pilot study to evaluate efficacy of a self-directed audio intervention on pain...

Running Head: PILOT STUDY TO EVALUATE EFFICACY

1

Pilot Study to Evaluate Efficacy of a Self-Directed Audio Intervention on

Pain, Anxiety, and Patient Satisfaction for Surgical Patients

Tanya G. Island

Texas Woman’s University

Author Note

Tanya G. Island, T. Boone Pickens Institute of Health Sciences, Texas Woman’s

University.

Correspondence concerning this dissertation should be addressed to Tanya G. Island, T.

Boone Pickens Institute of Health Sciences – Dallas Center, Texas Woman’s University, 5500

Southwestern Medical Avenue, Dallas, TX 75235-7299.

Contact: [email protected]

mailto:[email protected]

PILOT STUDY TO EVALUATE EFFICACY 2

Pilot Study to Evaluate Efficacy of a Self-Directed Audio Intervention on Pain, Anxiety, and

Patient Satisfaction for Surgical Patients

Patients waiting for surgery often experience anxiety and emotional distress related to

high levels of ambient noise, unfamiliar surroundings, and loss of privacy in curtained or semi-

private holding areas. Ebirim and Tobin (2011) described several factors impacting preoperative

patient anxiety and fear as the fear related to surgery schedule changes, fear of complications

resulting in death or injury, fear related to staff inattention, and fear of “not waking” after

surgery. Kindler and colleagues (2000) also found similar results, along with fears of survival

and fears related to not knowing what was happening. The duration of waiting time is

unpredictable and, oftentimes, patients have minimal interaction with hospital staff members

once the admission process is complete. Preoperative waiting areas are often high traffic areas

with patient throughput determined by surgical volume and caseload scheduling. Patients with

elevated stress and anxiety exhibit elevated vital signs and often require increased amounts of

sedative and anesthetic hypnotic medications to achieve adequate depth of anesthesia (Gonzales

et al., 2010; Kil et al., 2012, Kim & Choi, 2013). Options to aid in preoperative relaxation

encompass three main categories: a) pharmacological treatments; b) behavioral patient-centered

interventions; and c) staff-driven interventions, such as patient education and instructional

materials.

Current treatment interventions focus mainly on administration of anxiolytic medications

in the preoperative holding area. Benefits to this option include fast onset and synergistic effect

with other anesthetic medications (Carroll, Cullinan, Clarke, and Davis, 2012). Drawbacks


include the need for delayed administration due to legal, procedural, and administrative

requirements for patient surgical preparation and prolonged residual effects that may delay

emergence and/or discharge from a surgical facility (Carroll et al., 2012). Behavioral

interventions, such as noise-cancelling headphones with audio relaxation tracks, offer the benefit

of being self-directed, low cost, portable, and user-friendly (Johnson, Raymond, and Goss,

2012). Guided imagery offers patients a self-directed audio track with relaxation music

combined with positive affirmations about the upcoming surgery and a speedy recovery (Nelson

et al., 2013). Drawbacks include variability of therapeutic response and willingness of patients

to participate.

Dr. Moerman (1996) honed in on the screening and identification of patients who prefer

more information to help assuage fears during preoperative preparation. Providing the right

amount of information at the right time is critical to the patient’s ability to retain and feel

empowered by the intervention. Patient education offers the benefit of being low cost and

flexible enough to tailor to facility constraints and environments of care. Drawbacks include the

potential for inconsistency in the type of education delivered, staff variability in teaching depth,

time constraints and production pressure that may impair patient education efforts, and inability

to gauge patient understanding of patient education interventions.

Key elements of the literature review surrounding the use of audio interventions to aid

preoperative mind-body preparation and relaxation of surgical patients encompass three main

themes: a) validity and reliability of preoperative anxiety assessment tools; b) effects of

preoperative anxiety on anesthetic requirements; and c) therapeutic interventions with reported

effectiveness at reducing preoperative anxiety.


Overview and Purpose

The purpose of this capstone project is to evaluate the efficacy of a self-directed audio

relaxation intervention for pain, anxiety, and patient satisfaction outcomes measures for the

outpatient surgical population at Memorial Hermann Surgical Hospital – First Colony. The

project aims are to translate evidence regarding effectiveness of self-directed audio relaxation

interventions to the practice setting of a community hospital in Sugar Land, Texas.

SWOT Analysis

The following section will describe a SWOT analysis of the environment of care in which

the intervention will be conducted. The strengths of the facility include an engaged perioperative

care team willing to tackle a known clinical problem, a customer-focused and service-driven

perioperative department, nursing staff that participates in all levels of the organization, and an

executive leadership team that is on board and fully supportive of an intervention aimed at

reducing anxiety in the preoperative area. The weaknesses are the high volume of patients and an

organizational emphasis on efficiency and throughput that may discourage attention and follow-

through with a process improvement or clinical investigation. Another weakness is the variable

response of patients to a self-directed relaxation intervention. The success of the intervention

may be highly variable and dependent on the willingness of patients to cooperate with a

distraction technique to reduce anxiety. Lastly, the nursing staff is currently task-focused, rather

than process- or outcome-driven. One advantage of the environment is that the patients of this

facility currently engage in alternative and complementary therapies. Several patients report use

of non-pharmacological approaches to alleviate stress and anxiety. By providing an intervention

of this type to a population already familiar with complementary therapies may lead to increased

acceptance by subjects. The opportunity to shift the nursing culture in the organization to a more


proactive approach to outcomes-based care is also present. The threats include lack of

participation by patients who decline the intervention.

Problem Statement

Patients waiting for surgery experience a wide range of emotions. Fear stems from

several patient concerns, including fear of not waking up after surgery, pain and surgical

complications, the unknown and fear associated with strange surroundings (Gonzales et al., 2010

and Kindler et al., 2000). Current models of surgical preparation are task-focused and often

require patients to sit for variable amounts of time in a semi-private holding area without any

sedative medication or entertainment options. The inadequate mind-body preparation of patients

results in patients experiencing varying levels of anxiety, emotional distress, and fear, which

contributes to increased sympathetic response and catecholamine release (Nelson et al., 2013).

This is clinically apparent in nervous patients exhibiting elevated blood pressure, increased heart

rate, and diaphoresis. Non-pharmacological interventions may provide significant clinical benefit

for preoperative patients and warrant further inquiry (Pellino et al., 2005).

Clinical Inquiry

Will a self-directed audio intervention reduce overall perioperative anxiety and pain

experienced by surgical patients at a community hospital? Can perioperative patient satisfaction

scores for patients improve by providing a mind-body intervention in the preoperative holding

area?

Research Questions

● Will a self-directed audio intervention reduce overall perioperative anxiety experienced

by surgical patients at a community hospital?


● Will a self-directed audio intervention reduce overall perioperative pain and narcotic

consumption experienced by surgical patients at a community hospital?

● Will a self-directed audio intervention improve overall patient satisfaction with surgical

services at a community hospital?

● Can this mind-body intervention be successfully piloted at a community hospital, thereby

translating research into clinical practice?

Hypotheses and Null Hypotheses

The self-directed audio intervention will decrease anxiety experienced by surgical

patients. The self-directed audio intervention will decrease pain scores and narcotic consumption

experienced by surgical patients. The self-directed audio intervention will improve patient

satisfaction scores. The self-directed audio intervention will be successfully piloted at a

community hospital, demonstrating translation of evidence-based practice into clinical practice.

The null hypothesis states that the self-directed audio intervention will not improve pain,

anxiety, and patient satisfaction outcomes in surgical patients at a community hospital.

Statement of Intervention

The anxiety-provoking experience of waiting for surgery in a semi-private curtained

holding area for an unknown duration of time precipitates elevated vital signs, increased

anesthetic demand, and can contribute to delayed wound healing and negative surgical outcomes

(Broadbent et al., 2012). Based on a review of literature and the existing practice environment,

the intervention for this pilot study will include an audio intervention that contains both guided

imagery relaxation tracks provided by Health Journeys (2014) and an FM tuner for patient-

selected local radio broadcasting.


Patients admitted to the preoperative holding area will be assigned a curtained bed space.

Once the staff complete their intake procedures, the PI will enter the room and perform the

preanesthesia assessment along with a description of what to expect from an anesthesia

standpoint. Informed consent for anesthesia services will be obtained at this time. After this is

complete and the patient has had an opportunity to ask questions, the study description will be

provided and informed consent will be obtained. Each patient will be briefed on the study

conditions, procedures, risks and benefits. If the patient agrees to participate, the informed

consent document (see Appendix B) will be signed and witnessed by preoperative nursing staff.

At this time, the patient will complete the anxiety assessment and pain tool. Music equipment

will be provided to the patient once baseline data has been collected. The noise cancelling

headphones will help to reduce ambient noise levels experienced by patients. The MP3 player

will be handheld, portable, low cost, and easy to operate.

Subjects who agree to participate in the intervention will be provided a brief instructional

description of how to use the equipment, adjust the volume, and size the headset. The PI will

leave the curtained area and offer privacy to the patient to listen to the device. The subjects will

continue to listen to the audio intervention as they travel from the holding area to the surgical

suite where the device will be removed after anesthetic induction. The headsets will be placed

back on once the patient has surpassed Stage II of anesthetic depth and the patient will continue

listening while resting in the post-anesthesia care unit. Once the patients have met discharge

criteria, the equipment will be recovered, sanitized and returned to the storage area in the locked

medication dispensation room for the next subject’s use. Study participants will complete an

anxiety tool, pain tool, and hospital patient satisfaction survey prior to discharge.


To aid in the mind-body preparation of surgical patients, a self-directed guided imagery

audio relaxation tool will be provided. The noise-cancelling headset and MP3 player will be

provided after a description of the study is relayed to the patient and informed consent is

obtained. The non-intervention group will receive standard treatment and will provide informed

consent to be evaluated as the control group. All participants will have a preoperative and

postoperative data collection of pain and anxiety, as well as postoperative patient satisfaction.

PICO or PICOT Question

P: Surgical patients scheduled for outpatient surgery at a community hospital in a

southern Texas city.

I: Self-directed audio relaxation guided imagery intervention with noise-cancelling

headphones and MP3 player during the preoperative stage.

C: Standard care with no audio intervention or distraction devices, pharmacological

intervention of anxiolytic and narcotic medications prior to transport to operating room.

O: Measures of pain, anxiety, narcotic consumption and patient satisfaction with

perioperative experience.

T: Three-month pilot study investigation period from January to March 2015.

Clinical Inquiry

In surgical patients scheduled for outpatient surgery at a community hospital in a

southern Texas city, how does a self-directed audio relaxation guided imagery intervention

compare to pharmacological anxiolytic and narcotic medication administration in the outcome

measures of pain, anxiety, narcotic consumption, and patient satisfaction during the 3-month

pilot study investigation window of January to March 2015?


Evidence-Based Practice Model — Guiding Framework: Stetler Model

The Stetler model provides a targeted approach to identifying factors and critically

evaluating all the dimensions of the clinical problem of high levels of ambient noise and low

patient satisfaction with the preoperative waiting experience. The surgical department helped to

identify the problem along with confounding factors, such as high staff traffic and patient family

member traffic in and out of the holding area. Critical evaluation of factors included a discussion

of what the literature review revealed as well as how the physical facility limited options for

solving the problem. Executive leadership of the hospital embraced a self-directed audio

intervention due to low cost, high portability, and ease of use.

Guiding Framework

Stetler Model for Evidence-Based Practice

Define: Patients report high levels of ambient noise and increased anxiety while waiting

in the preoperative holding area, decreased patient satisfaction scores related to preoperative

waiting experience

Assess: Critical evaluation of factors

Evidence-based factors: Multiple peer-reviewed sources indicate patients may

experience reduced preoperative anxiety when listening to audio devices

programmed with guided imagery relaxation tracks and personal music

selections in the holding area.

Patient factors: Patients experience fear of the unknown, fear of anesthetic and

surgical complications, and fear of unfamiliar settings while waiting for

surgery.


Clinical setting factors: Curtained, semi-private holding area with minimal

noise-cancelling barriers due to physical facility constraints, high staff and

patient family member traffic, close proximity to post anesthesia care unit

which leads to increased traffic, and a high volume of cases leads to increased

throughput and increased ambient noise.

Plan: Following approval obtained by the executive leadership committee, a pilot study

was developed to facilitate a prompt solution to a known clinical problem of interest.

Communication to staff members at monthly surgical department staff meeting is

tentatively planned for December 2014 in order to ensure all appropriate approvals have

been obtained from TWU.

Implement: Plans are to begin the pilot study and data collection in January 2015.

Evaluate: Outcomes will be analyzed and evaluated in March 2015. Reports will be

created and a presentation will be prepared and provided to the executive committee in

April 2015. Based on the outcomes of the pilot study, a tentative plan includes expansion

of the pilot study to all surgical patients at the community hospital. Fit and feasibility of

widespread implementation for all surgical patients will be considered.

Diagram of Stetler Model for Evidence-Based Practice:


Stetler Model for Evidence-Based Practice

(http://www.ktdrr.org/ktlibrary/articles_pubs/ktmodels/#stetler)


Review of Literature

A comprehensive article search was conducted using Google Scholar, TWUniversal,

Cinahl, PubMed and Medline using terms preoperative anxiety, perioperative anxiety, anxiety in

holding area, anxiety and anesthetic demand, anxiety and surgical pain, anxiety and patient

satisfaction, guided imagery and preoperative anxiety, music and preoperative anxiety. The

initial number of articles returned totaled 16,700. Articles were limited to publication years 2000

to 2014 to identify most recent findings relevant to the topic of interest. Criteria for inclusion

included study samples focusing on adult patients scheduled for outpatient surgery or day

surgery. Articles that focused on audio interventions were targeted with specific emphasis on

peer-reviewed clinical research articles. Five main types of articles were identified: a) reliable

and valid assessment of study variables; b) theoretical dimensions of anxiety and pain

phenomenon; c) music interventions and the influence of music on physiology; d) guided

imagery and mind-body relaxation interventions; and e) pharmacological therapies and novel

technological approaches.

Background

Patients experience heightened emotional distress while waiting for scheduled surgery in

the preoperative holding area. The semi-private holding area has high levels of ambient noise,

high staff volume, and provides minimal comfort to nervous patients. The lack of entertainment

options and unfamiliar surroundings contribute to a heightened emotional state that adds to

feelings of anxiousness and helplessness (Moerman et al., 1996; Biddiss and Knibbe, 2014;

Cserep et al., 2012; Theunissen, Peters, Bruce, Gramke, and Marcus, 2012; and Tully et al…,

2011). The duration of waiting varies based on scheduled or unscheduled surgical procedures,

surgeons’ work schedules and staff/equipment availability. Patients overhear inappropriate


speech, confidential patient-physician communications, and other noise unrelated to their

healthcare needs.

Literature Search Process

A comprehensive article search was conducted using Google Scholar, TWUniversal,

Cinahl, PubMed, and Medline. The search terms included preoperative anxiety, perioperative

anxiety, anxiety and holding area, anxiety and anesthetic demand, anxiety surgical pain, anxiety

patient satisfaction, guided imagery preoperative anxiety, music and preoperative anxiety.

Initial number of articles returned totaled 16,700. Articles were limited to publication years 2000

to 2014 to identify most recent findings relevant to the topic of interest. Of 16,700 initial search

results, the final literature review focused on 49 sources. Included articles were peer-reviewed

from clinical journals and contained subject matter pertinent to the proposal topic. Exceptions to

the inclusion criteria were a well-written dissertation thesis and primary source descriptions of

anxiety assessment tools. Excluded articles included those not written in English and those with

little to add to the synthesis of available information.

Review of Literature

Nearly all studies described the high levels of anxiety experienced by surgical patients

while waiting in the holding area (Biddiss and Knibbe, 2014; Cserep et al., 2012; Theunissen,

Peters, Bruce, Gramke, and Marcus, 2012; and Tully et al., 2011). Preoperative anxiety in the

perioperative period can contribute to several negative health outcomes, including increased vital

signs, increased postoperative pain, delayed wound healing, emotional distress, increased

anesthetic requirements and decreased patient satisfaction (Kim, Byeon, Song, and Lee, 2010;

Kil et al., 2012; Yiu, 2012; and Kindler et al., 2000). Clinicians may be unaware of the level of

preoperative anxiety or the need for additional information to help mitigate fear and worry. A


multi-modal strategy that includes a self-directed intervention may alleviate the emotional

distress associated with waiting in the holding area prior to surgery and may improve surgical

outcomes after surgery. The following section describes several major themes that emerged from

a systematic review of the literature.

Synthesis of Literature

The following themes emerged from a synthesis of the literature: a) accurate assessment

of variables; b) effects of anxiety; c) effects of pain; d) music interventions; e) guided imagery

and relaxation interventions; and f) the use of novel techniques and pharmacological therapies.

Assessment tools for anxiety and pain. Several authors described a myriad of

assessments, instruments, and tools used to objectively quantify, evaluate, and comparatively

analyze the dimension of anxiety. Dr. Aitken (1969) initially described the use of a numeric

visual analog scale (VAS) to quantify and evaluate the patient perception of emotional

experiences. Further studies that subsequently elaborated on the reliability and validity of the

VAS applied the analysis specifically to the perioperative environment (Davey, Barratt, Butow,

and Deeks, 2007; Deloach, Higgins, Caplan, and Stiff, 1998; Facco et al., 2011). All authors

used factor analysis and statistical methods to demonstrate intrasubject and interrater reliability

and validity for the VAS for perioperative anxiety. Other measures described in the literature

were more facility specific and addressed concerns in specific areas, such as fears related to

anesthesia, fears related to surgery, and fears related to pain after surgery (McIntosh and Adams,

2011; Moerman et al., 1996; and Theunissen et al., 2014). The Amsterdam Preoperative Anxiety

and Information Scale proposed by Dr Moerman (1996) was deemed most suitable for the

purposes of the proposed pilot study due to its succinct and descriptive focus areas. Both of the


study instruments, VAS-Anxiety and APAIS were demonstrated to be reliable and valid in

assessment of preoperative anxiety in surgical patients.

Effects of anxiety. Tully and colleagues (2011) investigated the relationship between

anxiety and postoperative new-onset atrial fibrillation in coronary surgery patients. Results

indicated that preoperative autonomic arousal, which is observed in high-anxiety states, increases

the risk of atrial fibrillation. Along with arrhythmias, preoperative anxiety may contribute to

alterations in pain pathways. Abrishami and colleagues (2011) conducted a thorough

investigation of pain sensitivity and its effect on post-operative surgical-related pain. The

researchers described the complexity of pain assessment, the pain experience, and the

biochemical foundations of pain processing in the nervous system. The meta-analysis of

preoperative pain sensitivity to heat, electricity, and pressure and its relation to post-surgical pain

showed that heightened preoperative anxiety correlated strongly with postoperative pain

(Abrishami et al., 2011). In addition to surgical complications, anxiety may contribute to

decreased mortality. Cserep and researchers (2012) investigated the relationship between

depression, anxiety and mortality after cardiac surgery. Results indicated mortality was closely

associated with advanced age, higher risk stratification, comorbid diabetes mellitus, higher

anxiety and depression scores, and lower education level (Cserep et al., 2012). The physiologic

effects of anxiety are extensive and can lead to adverse health outcomes.

Music interventions. Numerous studies demonstrated marked clinical benefit in

utilization of music devices and audio interventions. In his translational research dissertation, Au

(2010) investigated a music intervention to reduce anxiety in emergency room patients in Hong

Kong during minor surgical procedures that were done under local anesthesia. Thoma, La Marca,

Bronnimann, Finkel, Ehlert and Nater (2013) compared the effects of three different conditions


(rippling water audio, relaxing classical music, and rest without audio) on the variables of

salivary cortisol, salivary alpha-amylase, heart rate, respiratory sinus arrhythmia, subjective

stress and anxiety. The study results indicated a faster recovery to baseline hormone levels in the

relaxing music group and the lowest amount of stress hormone were found in the music

intervention group. Bradshaw and colleagues also found similar results in a laboratory simulation

of pain responses during task-demand, stimulus-evoked potentials. Music engagement reduced

subjective pain perception and anxiety level was found to be a confounding variable (Bradshaw,

Donaldson, Jacobson, Nakamura, & Chapman, 2011).

Chen, Wang, Shih, and Wu (2013) described a beneficial response to a music

intervention that lasted only 15 minutes. These results support the conclusion that an audio

intervention may be initiated on the morning of surgery for a brief period of time before transport

to the operating room and still confer anxiolytic benefits. Yeo and colleagues (2013) published

an interesting study of rigid cystoscopy performed under local anesthesia with music headsets

and, remarkably, no anesthesia medications. The researchers reported that subjects tolerated the

procedure well and watched the examination on a visual display monitor. The findings of the

study indicated that patients reported statistically significant improvements in pain and anxiety as

well as greater mean patient satisfaction scores (Yeo et al., 2013).

Biddiss, Knibbe and McPherson (2014) conducted a meta-analysis of interventions

intended to reduce preoperative anxiety in adult and pediatric patients. Of three interventions of

interest, music was found to be most effective in alleviating anxiety for surgical patients as

compared to aromatherapy and interior design modifications. Another meta-analysis of 45

different studies concluded that music interventions led to decreased anxiety, decreased pain,


decreased medication consumption of anxiolytics and narcotics, and decreased vital sign

parameters along with increased patient satisfaction (Wakim, Smith & Guinn, 2010).

Some studies described the effects of music interventions on hemodynamic parameters.

Loomba, Arora, Shah, Chandrasekar, and Molnar (2012) reported positive hemodynamic effects

of music on blood pressure and heart rate. Study results showed that music interventions across a

variety of clinical settings, including ICU, perioperative departments, and procedure treatment

areas, provided significant benefit to patients (Loomba et al., 2012). Bansal and co-researchers

(2010) also published similar findings in their population of patients who had spinal anesthesia

for abdominal, lower extremity or pelvic surgeries. Patients required approximately a third less

anxiolytic medications and had almost a 25-point reduction in heart rate while listening to

relaxing music. Furthermore, patient satisfaction scores were significantly higher in the music

group (Bansal et al., 2010). Ko and Lin (2012) reported a statistically significant reduction in

vital signs and anxiety level with a relaxation tape intervention in surgical patients.

Two well-known clinical research entities, the Cochrane Database Review (Bradt, Dileo

& Shim, 2013) and the Joanna Briggs Institute (Kusi‐Amponsah, Allcock, Stanton, & Bath‐

Hextall, 2010), both published comprehensive meta-analysis articles describing the numerous

benefits of music interventions on reduction of pain, anxiety, and emotional distress. The

findings point at music as a beneficial intervention in the management of anxiety, pain and

hemodynamic stability for surgical patients.

Guided Imagery. Several investigations focused directly on the therapeutic benefits

associated with guided imagery interventions. The benefits were observed across several

different surgical delivery lines, including cardiac surgery, abdominal surgery, same-day surgery,

and intra-abdominal general surgery (Attias et al., 2014; Casida and Lemanski, 2010; Gonzales


et al., 2010; and Stein et al., 2010). Guided imagery was delivered in a self-directed audio format

for the majority of interventions. Jong, Pijl, de Gast, and Sjoling (2012) described a self-directed

intervention with a guided imagery audio CD that was given to the patient one week prior to

surgery. Although significant benefits were observed in narcotic consumption and self-reported

pain, compliance with daily use of the intervention was found to be challenging. In contrast to a

self-directed intervention, other researchers attempted to use a hospital-based broadcasting

system to deliver the guided imagery cues.

One particular investigation targeted the delivery and efficacy of alternative methods of

guided imagery audio cues and compared the use of headsets to a loudspeaker, broadcast device

(Lee et al., 2011). Headsets were found to be superior to a broadcast device in the waiting area

prior to surgical procedure. Stein and researchers (2010) conducted an evaluation of the

effectiveness of guided imagery for coronary surgery patients. Findings pointed at the

complexity of emotional experiences and postoperative recovery in cardiac surgery patients;

however, the study demonstrated the willingness of older adults to participate in complementary

audio therapies.

Feasibility of guided imagery interventions was confirmed by Jacobsen, Lewandowski,

Palmieri, and Myerscough (2011) in a convenience sample of 20 subjects. The findings of the

study indicated that time of day and location of listening to the audio intervention impacted

clinical benefit. The consensus reached by numerous authors was that guided imagery offered

significant clinical benefit as shown by reduced anxiety, less variation in vital signs, and

reduction in postoperative pain (Attias et al., 2014, Casida and Lemanski, 2010; and Gonzales et

al., 2010).


Relaxation interventions and mind-body therapies. A multitude of non-

pharmacological interventions have been researched in order to facilitate mind-body preparation

of surgical patients. A meta-analysis of 20 studies conducted by Nelson and colleagues (2013)

indicated that, of several different approaches to mind-body preparation of surgical patients,

guided imagery appeared to provide the most significant benefit. Much of the data indicate a

statistically significant improvement in anxiety, pain, and narcotic consumption when a guided

imagery intervention was utilized. Other mind-body therapies investigated included hypnosis,

relaxation coaching and guided imagery, with promising results for guided imagery (Nelson et

al., 2013).

Novel technological approaches and pharmacological therapies. Unique approaches

to anesthetic management and mitigation of preoperative anxiety were identified in the literature.

Newman, Boyd, Meyers, and Bonanno (2010) described the use of patient-selected music to

facilitate anesthetic induction for Monitored Anesthesia Care cases in a systematic review of 10

articles. These findings provided a clinical protocol for incorporation of patient-selected music in

the perioperative care environment. This novel technique led to reduction in medication

requirements, decreased time to adequate anesthetic depth, and decreased anxiety and pain

(Newman et al., 2010). Further research should focus on scientific evaluation of the protocol for

reliability and validity as well as randomized trials in other settings.

Gorini and colleagues (2010) described a portable immersive audio and video simulation

system that helped patients relax while waiting for surgery by creating a mock nature scene on

specialized patient goggles. The subjects utilized the device throughout the perioperative period

and experienced an uninterrupted relaxation intervention, delivered via a video simulation

apparatus (Gorini et al., 2010). Subjects wore the goggles and earphones while having local


anesthesia, however, no additional intravenous sedation was concurrently administered. The

emphasis by Gorini and colleagues (2010) was that utilization of immersive head-mounted

display with earphones was a cost effective alternative to medication administration, risk of

patient movement, and patient perceptions of pain and discomfort.

Instrumentation, Population, and Sample Instrumentation

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the Visual

Analog Scale (VAS) will be used to assess anxiety levels while patients are waiting in the

holding area. Permission from Dr. Moerman has been obtained to use the APAIS in this

investigation. Construct validity was determined using factor analysis that pointed at anxiety and

the need for information as the two primary factors of the instrument (Moerman, 1996).

Concurrent validity was evaluated using the gold standard State Trait Anxiety Inventory (STAI)

with positive correlation for anxiety in both tools (Moerman, 1996). Sensitivity, specificity, and

positive predictive value were all evaluated using the STAI (Moerman, 1996). Known group

comparisons were analyzed using ANOVA and the Student’s t test, and reliability was

considered acceptable using Cronbach’s alpha ≥70 (Moerman, 1996). Using the APAIS tool, the

cutoff value for anxious patients was found to be 11 and for patients needing additional

information, the value was 5.

Additional information will be obtained during the intake assessment, including pain,

home medications, baseline vital signs, and other pertinent medical and surgical history. The

pain and anxiety baseline scores will be rated on a 100-point scale. Patient pain scores and

assessments will be entered in the facility’s electronic health record. Patient satisfaction with the

intervention will be asked during postoperative data collection.


Population and Sample

Based on a power analysis using an alpha of 5% to a 95% confidence interval and a beta

of 50% with 1.0 standard deviation and test value of 35 and sample average of 50, the sample

size needs to be 168 subjects (Decision Support Systems, 2014). Inclusion criteria include all

English-speaking outpatient surgery patients between the ages of 18-65 scheduled for general,

podiatry, ear-nose-throat (ENT) or colorectal procedures. Exclusion criteria will include chronic

pain disorders, chronic psychiatric disorders, or unwillingness/inability to participate in the

investigation. Patients who receive regional anesthesia nerve blocks will also be excluded from

the study sample to avoid clouding subjective pain and anxiety experienced during perioperative

care.

Patients will be randomized on the morning of surgery to receive either the control or

intervention. Between 3 and 4 patients will be enrolled in the study each day. Assignment to

intervention or control groups will be randomized using a computer generated web-based

randomizer located at www.randomizer.org. The population of patients are located at a

community surgical specialty hospital in a South Texas city.

The patients will sign the consent (see Appendix B) after a study briefing is administered

by the PI in the preoperative holding area. The study briefing will begin after the preanesthesia

assessment is completed and a signed anesthesia informed consent has been obtained. After the

standard anesthesia preparation is complete, the intervention group will receive audio equipment.

The control group will receive standard treatment, which includes no headphones and

pharmacological anxiolytic medications prior to transport to the operating room. Both groups

will have baseline data collected in the Electronic Medical Record (EMR) in the post-anesthesia

care unit (PACU) and prior to discharge.


Description of Proposed Intervention

Patients scheduled for surgery will be admitted by preoperative nursing staff in the usual

fashion. Once the admission process is complete, the PI will enter the holding area and discuss

the study. If the patients agree to participate, written consent (see Appendix B) will be signed

and witnessed by preoperative nursing staff members. The intervention will be described in

detail and, if patients are assigned to the intervention group, headsets will be provided to patients

while waiting for transport to the operating room. Adjustments to headsets and volume of music

will be made with assistance of the PI. Questions will be asked and answered prior to beginning

the intervention. All baseline data, including anxiety tools and pain assessment will be completed

during the admissions and intake process.

Once patients are transported to the operating room, the audio intervention will continue

playing until anesthetic induction is complete. The headset will be removed and stored until the

surgery is complete. After emergence from anesthesia is complete, the headset will be replaced

on the patient’s ears for further listening during the immediate recovery period. Once the patient

has achieved discharge criteria from the post-anesthesia care unit, the headphones will be

removed and sanitized. The patient will complete discharge paperwork and assessment,

including a pain, anxiety and patient satisfaction assessment. An exit consultation with

anesthesia personnel and the PI will be conducted immediately prior to discharge and any

questions or concerns will be addressed at that time.

Implementation

Staff meetings during November and December 2014 will include an explanatory

briefing to surgical department nursing staff regarding the study aims, design and protocol. A

brief description of the assessment tools and intervention will be provided to nursing staff.


Coordination with the Information Technology (IT) department will proceed on a biweekly basis

until January 2015. Meetings with IT personnel will encompass development of a study

instrument, integration of the study instrument into EMR and construction of reports within

EMR. All baseline admission data will be extracted from the nursing admissions flowsheet

located in the Cerner electronic health record. Collaboration and coordination meetings with the

Information Technology Department have been occurring on a bi-monthly basis since August

2014. Reporting tools for the electronic health record (see Appendix D) are in the development

and testing phase and are expected to be functional by November 2014. Data collection is

scheduled to begin in January 2015. Study participants exposed to the experimental condition

will be selected based on random number generation software on the morning of surgery. IRB

approval is expected to be completed by November 22, 2014. The Executive Summary document

has been signed, approved, and accepted by the facility’s executive leadership committee (see

Appendix C).

Project Objectives and Timelines of Phases

The project seeks to improve the mind-body preparation of surgical patients scheduled

for outpatient surgery. The project also seeks to alleviate stress and anxiety associated with

waiting for scheduled surgical procedures. Furthermore, the project seeks to overcome physical

and structural limitations of the facility in which the investigation is being conducted by

providing a distraction in a curtained holding area with high ambient noise and limited privacy.

Phase I of the project includes proposal submission, approval and defense, which is

expected to be completed by December 4, 2014. During Phase I of the project, IRB approval will

be obtained, staff inservices will be conducted and all preparatory groundwork will be


completed. Cost estimates will be prepared and approved by the Executive Committee. Upon

immediate completion of Phase I, study equipment will be purchased and prepared for Phase II.

Phase II of the project includes baseline data collection and trial of existing process. Test

subjects will be used to evaluate the process and ensure smooth operation of study protocol.

Phase II will run from December 8, 2014 through December 22, 2014.

Phase III of the project includes initiation of the pilot study. Patient education handouts

will be provided to study participants and posters describing the study process will be placed in

lounge areas. Enrollment of study participants will begin on January 3, 2015 and participants will

be enrolled until sample size reaches 78. The study process and data collection will be monitored

by the PI throughout the study period. During staff inservices, the surgical department will

receive a brief synopsis of the pilot study status.

Phase IV of the project includes data analysis, reporting, and presentation of findings.

This phase is expected to begin on April 1, 2015. The data will be analyzed with the assistance of

a statistician and the results will be reported to the facility Executive Committee, the surgical

department staff, and the TWU Capstone Committee. This phase will be completed in mid-April

and will conclude with all necessary documentation and submissions to the TWU School of

Nursing Doctorate of Nursing Practice Program Chair.

Data Collection

● Preoperative anxiety and pain assessment data will be recorded in the EMR on the Study

Data Tool (see Appendix D) during admissions and the intake process. The EMR

Preoperative Admission Flowsheet also has a subheading for pain and anxiety, which will

be accessed and completed during admission to the preoperative holding area.


● Patients who are identified to participate in the study will complete the APAIS with

results entered into a separate reporting tool located in the EMR (see Appendix D).

● Medication consumption and perioperative anxiolytic/narcotic administration will be

extracted from the Medication Administration Record (MAR) and entered on the Data

Tool (see Appendix D) located in the EMR.

● Participants’ medical records will have the tab entitled ’Study Intake Data Worksheet’

completed both before and after the intervention. This worksheet will then feed data into

a ’Study Data Report’ that will be accessed by the PI weekly.

● The study data tool, along with standard anxiety and pain flowsheets, will be completed

again in the Phase II discharge area. The patient satisfaction response will be recorded in

the study data tool. The tool will automatically populate the ’Study Intake Data Report,’

which will be accessed daily for the first week and weekly thereafter.

● Coordination with the Information Technology Department will continue throughout the

study period. Any concerns or observed reporting errors will be immediately brought to

the attention of the Information Technology department. Written study data tools will be

present in the perioperative treatment areas to ensure uninterrupted collection of data in

the event of EMR malfunctions.

Results and Findings

● ANOVA and Student’s t test will be conducted on study variables for pre-and post-test

analysis. A statistician has been consulted during proposal development and will be enlisted

to aid in a full statistical analysis of outcome variables.

Institutional Review Board (IRB)


● An IRB package has been submitted for expedited review and results are pending at the

time of submission of this proposal to the TWU Capstone Committee.

Evaluation, Outcomes, Implications, and Future Directions

Guiding Framework

● The final step in the Stetler model includes evaluation of the intervention to determine if

expected outcomes were as expected based on implementation of the intervention. During

this phase, clinical findings will be analyzed and findings will be reported to all

stakeholders. A cost-benefit analysis will also be considered in light of the study findings

and practicality of a broader application of the intervention. Utilization of research and

application of clinical findings will be an ongoing process of incremental evaluation and

modification to improve the process of rolling out the intervention.

● Once the data collection period ends in April 2015, a comprehensive statistical analysis

will be conducted. Findings will be presented to the Executive Committee of the hospital

and to staff members in the perioperative care areas. Based on the findings of the pilot

study, the intervention may be expanded as a permanent preoperative surgical preparation

intervention.

Outcomes

● Pre-intervention and post-intervention pain

● Pre-intervention and post-intervention anxiety

● Post-intervention patient satisfaction

● Narcotic consumption

● Anxiolytic drug consumption

● Description of statistical correlations between APAIS tool and anxiety score


● Conclusions and findings

Implications

Lessons learned will be described here.

Suggestions for future investigators will be described here.

This section will be completed after data collection and statistical analysis.

Future Directions

● Further research should be conducted in application of the intervention in different

surgical populations, including ophthalmic procedures, colonoscopy and endoscopy, and

both radiology procedures and diagnostic testing, such as ultrasounds, CT scans, and

MRIs.

● Additionally, collaboration with Biomedical Technicians may be beneficial to ensure no

concerns are raised regarding the presence of electrical devices in the Surgery

Department and the potential for interference with surgical equipment.


References

Abrishami, A., Chan, J., Chung, F., & Wong, J. (2011). Preoperative pain sensitivity and its

correlation with postoperative pain and analgesic consumption: a qualitative systematic

review. Anesthesiology, 114(2), 445-457.

Aitken, R. C. (1969). Measurement of feelings using visual analogue scales. Proceedings of the

Royal Society of Medicine, 62(10), 989.

Attias, S., Keinan-Boker, L., Sroka, G., Matter, I., Arnon, Z., & Schiff, E. (2014). The

effectiveness of a generic Guided Imagery CD compared with individualized

complementary therapies and standard of care for reducing preoperative anxiety:

preliminary results. The Journal of Alternative and Complementary Medicine, 20(5),

A137-A137.

Au, M. Y. (2010). Appropriateness and feasibility of music intervention in reducing anxiety for

patients undergoing minor operative procedures in Accident and Emergency

Department. HKU Theses Online.

Bansal, P., Kharod, U., Patel, P., Sanwatsarkar, S., Patel, H., & Kamat, H. (2010). The effect of

music therapy on sedative requirements and hemodynamic parameters in patients under

spinal anesthesia: a prospective study. Journal of Clinical and Diagnostic Research,

4(4), 2782-87.

Biddiss, E., Knibbe, T. J., & McPherson, A. (2014). The Effectiveness of Interventions Aimed at

Reducing Anxiety in Health Care Waiting Spaces: A Systematic Review of Randomized

and Nonrandomized Trials. Anesthesia & Analgesia, 119(2), 433-448.

Bonnel, W. & Smith, K.V. (2014). Proposal Writing for Nursing Capstones and Clinical

Projects. New York: Springer.


Bradshaw, D.H., Donaldson, G.W., Jacobson, R.C., Nakamura, Y., & Chapman, C.R. (2011).

Individual Differences in the Effects of Music Engagement on Responses to Painful

Stimulation. Journal of Pain, 12(12), 1262-1273. doi:10.1016/j.jpain.2011.08.010.

Bradt, J., Dileo, C. & Shim, M. (2013). Music interventions for preoperative anxiety. The

Cochrane Library, 6, 1-84. doi: 10.1002/14651858.CD006908.pub2.

Broadbent, E., Kahokehr, A., Booth, R. J., Thomas, J., Windsor, J. A., Buchanan, C. M… Hill,

A.G. (2012). A brief relaxation intervention reduces stress and improves surgical wound

healing response: a randomized trial. Brain, Behavior, and Immunity, 26(2), 212-217.

Carroll, J. K., Cullinan, E., Clarke, L., & Davis, N. F. (2012). The role of anxiolytic

premedication in reducing preoperative anxiety. British Journal of Nursing, 21(8), 479-

483.

Casida, J., & Lemanski, S. A. (2010). An evidence-based review on guided imagery utilization in

adult cardiac surgery. Clinical Scholars Review, 3(1), 22-30

Chen, L. C., Wang, T. F., Shih, Y. N., & Wu, L. J. (2013). Fifteen-minute music intervention

reduces pre-radiotherapy anxiety in oncology patients. European Journal of Oncology

Nursing, 17(4), 436-441.

Cserép, Z., Losoncz, E., Balog, P., Szili-Török, T., Husz, A., Juhász, B., & Székely, A. (2012).

The impact of preoperative anxiety and education level on long-term mortality after

cardiac surgery. Journal of Cardiothoracic Surgery, 7(1), 86.

Decision Support Systems. (2014). Sample Size Calculators. DSS Research. Retrieved from:

https://www.dssresearch.com/calculators/samplesizecalculators.aspx

DeLoach, L. J., Higgins, M. S., Caplan, A. B., & Stiff, J. L. (1998). The visual analog scale in

the immediate postoperative period: intrasubject variability and correlation with a numeric

https://www.dssresearch.com/calculators/samplesizecalculators.aspx


scale. Anesthesia & Analgesia, 86(1), 102-106.

Ebirim, L., & Tobin, M. (2011). Factors responsible for pre-operative anxiety in elective surgical

patients at a University Teaching Hospital: a pilot study. The Internet Journal of

Anesthesiology, 29(2).

Facco, E., Zanette, G., Favero, L., Bacci, C., Sivolella, S., Cavallin, F., & Manani, G. (2011).

Toward the validation of visual analogue scale for anxiety. Anesthesia Progress, 58(1), 8-

13.

Faul, F., Erdfelder, E., Lang, A.G. & Buchner, A. (2007). G*Power 3: A flexible statistical

power analysis program for the social, behavioral, and biomedical sciences. Behavior

Research Methods, 39, 175-191.

Gonzales, E. A., Ledesma, R. J., McAllister, D. J., Perry, S. M., Dyer, C. A., & Maye, J. P.

(2010). Effects of guided imagery on postoperative outcomes in patients undergoing

same-day surgical procedures: a randomized, single-blind study. AANA Journal, 78(3),

181-88.

Gorini, A., Mosso, J. L., Mosso, D., Pineda, E., Ruíz, N. L., Obrador, G. T., & Riva, G. (2010).

A portable immersive system as an alternative medical treatment to reduce anxiety in

minor surgical operations: a randomized controlled study. Virtual Worlds, Real Healing,

125.

Health Journeys. (2014). Safe Surgery Guided Imagery CD. Retrieved from:

http://www.healthjourneys.com/

Holly, C. (2014). Scholarly Inquiry and the DNP Capstone. New York: Springer.

Jacobsen, A.F., Lewandowski, W., Palmieri, P.A., & Myerscough, R.P. (2011). Feasibility trial

of guided imagery and control interventions in mock subjects. Applied Nursing Research,




24(2011), 45-52.

Jong, M., Pij, A., de Gast, H., Sjöling, M. (2012). The effects of guided imagery on preoperative

anxiety and pain management in patients undergoing Laparoscopic Cholecystectomy in

a multi-center RCT study. BMC Complementary and Alternative Medicine,

12(Supp1),184.

Kil, H. K., Kim, W. O., Chung, W. Y., Kim, G. H., Seo, H., & Hong, J. Y. (2012). Preoperative

anxiety and pain sensitivity are independent predictors of propofol and sevoflurane

requirements in general anesthesia. British Journal of Anesthesia, 108(1), 119-125.

Kim, Y. H., & Choi, W. J. (2013). Effect of preoperative anxiety on spectral entropy during

induction with propofol. Korean Journal of Anesthesiology, 65(2), 108-113.

Kim, W. S., Byeon, G. J., Song, B. J., & Lee, H. J. (2010). Availability of preoperative anxiety

scale as a predictive factor for hemodynamic changes during induction of anesthesia.

Korean Journal of Anesthesiology, 58(4), 328-333.

Kindler, C. H., Harms, C., Amsler, F., Ihde-Scholl, T., & Scheidegger, D. (2000). The visual

analog scale allows effective measurement of preoperative anxiety and detection of

patients’ anesthetic concerns. Anesthesia & Analgesia, 90(3), 706-712.

Ko, Y. L., & Lin, P. C. (2012). The effect of using a relaxation tape on pulse, respiration, blood

pressure and anxiety levels of surgical patients. Journal of Clinical Nursing, 21(5‐6),

689-697.

Kusi‐Amponsah, A., Allcock, N., Stanton, W., & Bath‐Hextall, F. (2010). Efficacy of music

listening as a postoperative pain management intervention in adult patients: a systematic

review. The JBI Database of Systematic Reviews and Implementation Reports, 8(24

Suppl), S301-319.


Lee, K., Chao, Y., Yiin, J., Hsieh, H., Dai, W. & Chao,Y. (2011). Evidence that music listening

reduces preoperative patients' anxiety. Biological Research for Nursing, 14(1),78-84.

doi: 10.1177/1099800410396704

Loomba, R. S., Arora, R., Shah, P. H., Chandrasekar, S., & Molnar, J. (2012). Effects of music

on systolic blood pressure, diastolic blood pressure, and heart rate: a meta-

analysis. Indian Heart Journal, 64(3), 309-313.

Mavros, M.N., Athanasiou S., Gkegkes I.D., Polyzos K.A., Peppas G., & Fallagas, M.E. (2011)

Do psychological variables affect early surgical recovery? PLoS ONE 6(5),1-6.

doi:10.1371/journal.pone.0020306.

McIntosh, S., & Adams, J. (2011). Anxiety and quality of recovery in day surgery: A

questionnaire study using Hospital Anxiety and Depression Scale and Quality of

Recovery Score. International Journal of Nursing Practice, 17(1), 85-92.

Nelson, E.A., Dowseya, M.M., Knowles, S.R., Castle, D.J., Salzberg, M.R., Monshat, K….

Choong, F.M. (2013). Systematic review of the efficacy of pre-surgical

mind-body based therapies on post-operative outcome measures. Complementary

Therapies in Medicine, 21, 697-711.

Newman, A., Boyd, C., Meyers, D., & Bonanno, L. (2010). Implementation of music as an

anesthetic adjunct during monitored anesthesia care. Journal of Perianesthesia Nursing,

25(6), 387-391.

Pellino, T. A., Gordon, D. B., Engelke, Z. K., Busse, K. L., Collins, M. A., Silver, C. E., &

Norcross, N. J. (2005). Use of nonpharmacologic interventions for pain and anxiety

after total hip and total knee arthroplasty. Orthopaedic Nursing, 24(3), 182-190.

Pritchard, M.J. (2009). Identifying and assessing anxiety in pre-operative patients. Nursing


Standard, 23(51), 35-40.

Stein, T. R., Olivo, E. L., Grand, S. H., Namerow, P. B., Costa, J., & Oz, M. C. (2010). A pilot

study to assess the effects of a guided imagery audiotape intervention on psychological

outcomes in patients undergoing coronary artery bypass graft surgery. Holistic Nursing

Practice, 24(4), 213-222.

The Joanna Briggs Institute. (2011). The JBI best practice intervention sheet: music as an

intervention in hospitals. Nursing and Health Sciences, 13, 99-102. doi: 10.1111/j.1442-

2018.2011.00583.x

Theunissen, M. Peters, M.L. Bruce, J. Gramke, H., & Marcus, M. (2012). Preoperative anxiety

and catastrophizing: a systematic review and meta-analysis of the association with

chronic postsurgical pain. Clinical Journal of Pain, 00(00).

Theunissen, M., Peters, M. L., Schouten, E. G., Fiddelers, A. A., Willemsen, M. G., Pinto, P. R.,

& Marcus, M. A. (2014). Validation of the Surgical Fear Questionnaire in adult patients

waiting for elective surgery. PloS one, 9(6), e100225.

Thoma, M. V., La Marca, R., Brönnimann, R., Finkel, L., Ehlert, U., & Nater, U. M. (2013). The

effect of music on the human stress response. PloS One, 8(8), e70156.

Vaajoki, A., Pietila, A., Kankkunen, P., and Vehvilainen-Julkunen, P. (2011). Effects of listening

to music on pain intensity and pain distress after surgery: an intervention. Journal of

Clinical Nursing, 21, 708–717. doi: 10.1111/j.1365-2702.2011.03829.x

Wakim, J. H., Smith, S., & Guinn, C. (2010). The efficacy of music therapy. Journal of

Perianesthesia Nursing, 25(4), 226-232.

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Appendix A

Critical Analysis of Literature

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1. Title

2. Principal Investigator or First Author

3. Date

4. Country

5. Patient Population

6. Sample Size

7. Intervention of Interest

8. Design(Experimental, Observational, etc.)

9. Level of Evidence(I – VII)

10. Comparison of Interest

11. Outcome of Interest

12. Results of Study

13. Conclusion

14. Strengths

15. Limitations

Measurement of feelings using visual

analogue scales. Proceedings of the

Royal Society of Medicine, 62(10), 989.

Aitken, R. C.

(1969)

Scotland.

Researcher does not

specify sample size.

Assessment of emotional mood states

using a 100-mm visual scale.

Quasi-experimental design.

Level III

Assessment of

emotional states

via open-ended

questions, as

compared to

the100-mm visual

analog scale.

Using VAS was

effective in

capturing the

subjective

emotional mood

state. Reliability

and validity were

documented. VAS

is effective in

quantifying

emotional mood.

Sample size,

inclusion/exclusion

criteria,

randomization, and

methodology were not

described. The

strength of this study

is that it was one of

the original reports of

VAS in clinical use.

The visual analog scale in the

immediate postoperative period:

intrasubject variability and correlation

with a numeric scale. Anesthesia &

Analgesia, 86(1), 102-106.

Deloach, L.J.

1998.

USA.

Surgical patients

60

Assessment of VAS for immediate

post-operative pain measurement.

RCT.

Level II.

Assessment of

pain using

conventional

methods or VAS

Using VAS was

effective in

measurement of

pain in the

immediate

postoperative

period

Study participants

were surgical patients,

and this study

validates use of VAS

for postop pain

assessment. Small

sample size and

limitations in design

with blinding and

participation bias are

present.

Toward the validation of visual

analogue scale for anxiety. Anesthesia

Progress, 58(1), 8-13.

Facco E.

2011.

Italy.

Patients scheduled

for dental implants.

1114

Adequacy of VAS in measuring

procedure-related anxiety.

RCT.

Level II.

Comparison in

anxiety assessment

between two

instruments:

Dental Anxiety

Scale and VAS.

Validation of

VAS.

Statistically

significant

correlation between

DAS scores and

VAS in 72% of

cases. Remaining

28% discordance

may have been due

to other factors,

such as over and

underestimation by

different

instruments.

Study compared VAS

to the gold standard

anxiety assessment

tool (DAS) and

demonstrated

significant

concurrency. Further

studies are required

with larger sample

sizes and in different

clinical subsets of

patients outside of

dentistry.

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The visual analog scale allows effective measurement of preoperative

anxiety and detection of patients’

anesthetic concerns. Anesthesia &

Analgesia, 90(3), 706-712.

Kindler, C.H.

2000.

USA.

Surgery patients. 734

Comparison of VAS to STAI in assessing preoperative anxiety.

RCT.

Level II.

Comparison between 100mm

VAS and STAI in

adequacy of

assessing

preoperative

anxiety.

Statistically significant

correlation between

STAI and VAS in

anxiety assessment

in surgical patients.

Both construct and

concurrent validity

of VAS were

demonstrated using

factor analysis and

student’s T test.

Study also

identified ten

specific dimensions

of preoperative

anxiety.

Demonstrated validity of VAS for

preoperative anxiety

as compared to gold

standard STAI. Also

described specific

predictors and risk

factors for elevated

preoperative anxiety.

Additional studies in

multiple sites with

larger samples are

needed to strengthen

validity.

Anxiety and quality of recovery in day

surgery: A questionnaire study using

Hospital Anxiety and Depression

Scale and Quality of Recovery Score.

International Journal of Nursing

Practice, 17(1), 85-92.

McIntosh, S.

2011.

United Kingdom.

Day surgery patients.

54

Administered HADS and QRS to

quantify perioperative anxiety and

quality of recovery after day surgery.

RCT.

Level II.

Compared

preoperative

anxiety to

postoperative

anxiety, and

compared

preoperative

anxiety to

postoperative

recovery.

Variables

included: HADS

score, QRS score,

and correlations

between scores.

Preoperative

anxiety has been

linked to a variety

of poor surgical

outcomes. The

preoperative and

postoperative

anxiety were found

to be significantly

correlated. The

correlation between

quality of recovery

and postoperative

anxiety was found

to be significantly

correlated.

Strengthens the

argument to

adequately assess and

quantify anxiety in

the preoperative area,

despite time

constraints and

process limitations in

fast-pace of day

surgery. Small sample

size limits

generalizability.

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Validation of the Surgical Fear Questionnaire in adult patients waiting

for elective surgery. PloS one, 9(6),

e100225.

Theunissen, M.

2014.

Netherlands, Portugal.

Surgical patients. 1490 surgical

patients, 201 female

surgical patients,

1275 surgical

patients.

Assessment of surgical fear using SFQ.

Multi-site RCT.

Level II.

Staged factor analysis and

validation of SFQ

in assessing

surgical fear. First

stage involved

1490 Dutch

surgical patients

for exploratory

factor analysis.

Second stage

involved 201

Portuguese female

surgical patients

for exploratory

factor analysis.

Confirmatory

factor analysis

conducted in stage

III with Dutch

surgical patients.

SFQ demonstrated reliability and

validity in

adequately

assessing multiple

dimensions of

surgical fear.

Factor analysis,

construct and

convergent

validity, as well as

internal validity

were all

demonstrated in the

studies.

Thorough and comprehensive

validity assessment of

the SFQ. Provides a

useful and valid tool

to capture the

dimensions of fear

and anxiety

specifically associated

with surgical

procedures. Validated

SFQ in multiple

populations in

different countries

with five separate

investigations. Needs

to be evaluated in the

US with English-

speaking surgical

patients.

The Amsterdam preoperative anxiety

and information scale

(APAIS). Anesthesia &

Analgesia, 82(3), 445-451.

Moerman, N.

1996.

Amsterdam.

Outpatient surgery

patients.

320

Administration of STAI and APAIS

to assess anxiety.

RCT.

Level II.

State anxiety,

APAIS score, and

correlation

between variables.

Demonstrated

criterion and

construct validity

for the APAIS.

APAIS correlated

with the state-

anxiety.

Developed an

innovative tool to

assess preoperative

anxiety and need for

more information in

the preoperative

period. Tool needs to

be demonstrated in

English and in the

US, to be

generalizable to US

surgical patients.

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Availability of preoperative anxiety scale as a predictive factor for

hemodynamic changes during

induction of anesthesia. Korean

Journal of Anesthesiology, 58(4), 328-

333.

Kim, W.S.

2010.

Korea.

Surgical patients. 120

Assessment of preoperative anxiety and effects on hemodynamic

instability during anesthesia

induction.

RCT.

Level II.

Preoperative anxiety, gender

and age related

effects on

hemodynamic

instability during

anesthetic

induction. STAI

was used to

measure

preoperative

anxiety.

Demographic data

was collected,

including gender,

age and surgical

procedure.

Anesthetic

technique was

standardized for all

subjects.

Gender, state, and trait anxiety were

not appropriate

predictors of >

20% change in

hemodynamic

results during

induction. Age >

45 years was the

greatest predictor

of hemodynamic

instability.

Study determined anxiety is not a

predictor of

significant

hemodynamic

instability. Study

needs to be repeated

in a larger sample in

multiple centers.

Preoperative anxiety and pain

sensitivity are independent predictors

of propofol and sevoflurane

requirements in general

anaesthesia. British Journal of

Anaesthesia, 108(1), 119-125.

Kil, H.K.

2012.

Korea.

Women scheduled

for total

thyroidectomy.

100.

Impact of preoperative anxiety and

pain threshold on anesthetic

requirements under general

anesthesia.

Cross-sectional study.

Level III.

Patients completed

STAI and PSQ

preop. Baseline

BIS values and

BIS-anesthesia

were recorded at

varying depths of

anesthesia.

General anesthesia

maintained

consistently for all

subjects. Propofol

requirements and

BIS values were

matched to

preoperative

anxiety and pain

results.

Higher state and

trait anxiety was

found to be

predictive of

increased propofol

requirements.

Increased age was

associated with

lower pain

sensitivity.

Sevoflurane

requirement was

associated with

pain sensitivity

values. VAS 1hr

postop correlated

with STAI and

PSQ.

Higher preoperative

anxiety found to

correlate with

increased propofol

requirements, and

higher pain sensitivity

associated with higher

sevoflurane

requirements. Study

needs to be repeated

with larger sample

with both men and

women in different

surgical conditions.

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Factors responsible for pre-operative anxiety in elective surgical patients at

a University Teaching Hospital: a pilot

study. The Internet Journal of

Anesthesiology, 29(2).

Ebirim, L.

2011.

Nigeria.

Patients scheduled for surgery.

125

Assessment of factors contributing to preoperative anxiety.

Cross-sectional non-experimental.

Level VI.

Survey given to patients on the

night before

scheduled surgery

to determine

highest patient

concerns

contributing to fear

and anxiety.

Top concern (69%) was fear of

postponing the

surgery, mistakes

causing harm to the

patient was

reported in 64% of

respondents, and

fear of inattention

from staff members

was reported by

63%. Fear of “not

waking up” was

reported by 58%.

Least concern was

of PONV at 8%

Nearly 35% of

respondents had

significant

preoperative

anxiety, according

to VAS.

Survey identified contributing factors to

patient worry and fear

in this specific study

sample. Results have

limited

generalizability due to

small sample size and

possibility of other

geographical or

facility-specific

limitations affecting

surgical care. Further

studies may benefit

from analyzing

gender as a predictor

of preoperative

anxiety.

Effect of preoperative anxiety on

spectral entropy during induction with

propofol. Korean Journal of

Anesthesiology, 65(2), 108-113.

Kim, Y.H.

2013.

Korea.

Surgical patients.

92

Effects of preoperative anxiety on

spectral entropy at different points in

anesthetic induction and maintenance.

Quasi-experimental.

Level III.

Baseline anxiety

measured using

STAI. Anxiety

compared to

response entropy

and state entropy

at different time

points in anesthetic

care: pre-

induction, at loss

of consciousness,

time of

hemodynamic

changes, and at

emergence.

SE and RE values

at LOC correlated

with state anxiety

values. SE had

stronger correlation

to state anxiety

than RE. No

differences were

found in total

propofol

requirements to

LOC for all levels

of anxiety.

Demonstrates varying

levels of spectral

entropy based on

preoperative anxiety

with no difference in

propofol requirements

for all levels of

anxiety. Conflicts

with other studies

demonstrating

increased propofol

requirements for high

anxiety.

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Preoperative anxiety and catastrophizing: a systematic review

and meta-analysis of the association

with chronic postsurgical pain.

Clinical Journal of Pain, 00(00).

Theunissen, M.

2012. United Kingdom and Netherlands.

No sample size reported. Population

focused on surgical

patients.

Evaluation of whether or not preoperative anxiety and

catastrophizing predict chronic pain

after surgery.

Systematic meta-analysis review of

29/75 articles.

Level I.

Summary of current evidence

regarding whether

high preoperative

anxiety or pain

catastrophizing are

associated with

chronic post-

surgical pain

which is defined as

pain lasting 3

months or longer

after surgery.

14 different assessment tools

were used to

evaluate

psychological

predictors

including

preoperative state

and trait anxiety,

anxiety related to

procedure and

anesthesia, and

surgery stress. 21

different tools were

used to measure

pain-related

outcomes.55% of

studies showed

preoperative

anxiety or pain

catastrophizing was

significantly

associated with

higher rates of

CPSP. In all cases,

high levels of

anxiety or pain

catastrophizing

predicted worse

outcomes. With

regards to

musculoskeletal

pain, high

preoperative

anxiety and

catastrophizing

were associated

with CPSP.

In 16 of 29 included studies, at least one

measure showed a

significant correlation

to CPSP. Further

research needs to be

conducted with

standardization of

anxiety and pain

assessment, as well as

with randomization

and larger sample

sizes. Regarding

musculoskeletal pain,

further studies need to

distinguish between

pre-existing pain and

postoperative

surgical-related pain.

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Anxiety, depression, and stress as risk factors for atrial fibrillation after

cardiac surgery. Heart & Lung: The

Journal of Acute and Critical Care,

40(1), 4-11.

Tully, P.J.

2011.

Australia.

Patients scheduled for CABG.

226

Examination of whether anxiety is associated with postoperative new

onset atrial fibrillation after CABG

and to determine whether anxiety was

associated with AF after adjustment

for psychosocial variables.

Prospective study.

Level IV.

Patients were administered the

DASS scale

preoperatively and

postoperatively,

and categorized

into 1 of 4 groups:

autonomic arousal,

skeletal

musculature,

situational anxiety,

and experience of

anxious effect.

EKGS were

recorded

preoperatively and

postoperatively

each day for five

days.

25% of patients manifested new

onset postop AF.

Retained predictors

of AF: older age,

mitral

incompetence,

LVEF <30%, and

urgent CABG.

ANOVA suggested

modest relationship

between baseline

DASS and postop

DASS. No

differences

observed between

AF and non-AF

groups in terms of

postop DASS.

Preoperative

autonomic arousal

increased risk of

AF.

Postoperative anxiety was associated with

concurrent AF, and

not found to be

predictive. Further

research should be

conducted in different

types of surgical

procedures with more

diverse samples, and

in other countries.

The psychogenic link

between

psychological

variables and

arrhythmias should be

investigated on a

larger scale.

The impact of preoperative anxiety

and education level on long-term

mortality after cardiac

surgery. Journal of Cardiothoracic

Surgery, 7(1), 86.

Cserep, Z.

2012. Hungary.

Patients scheduled

for CABG or cardiac

valve surgery.

197

Aim of the study was to investigate

the incidence and time-course of

preoperative and post-discharge

depression and anxiety in patients

undergoing cardiac surgery; and to

examine association between

depression, anxiety, and mortality 7.5

years post-discharge.

Longitudinal cohort study.

Level IV.

Beck Depression

Inventory and

STAI used to

assess anxiety and

depression

preoperative and

postoperatively.

Long term follow-

up intervals were:

6, 12, 24, 36, 48,

60, and 82 months

post discharge.

Mortality rate for

sample was found

to be 23.6%. Death

was associated with

older age, higher

risk scores, DM,

higher BDI and

STAI scores and

lower education

level. No

significant changes

were found

between pre- and

post-op STAI. Trait

anxiety and

education level

were associated

with higher

mortality risk

during 7.5 years of

follow-up after

CABG or valve

surgery.

Future studies should

include patients

undergoing different

surgical procedures

and expand on the

researchers’ findings.

High attrition may be

due to length of

research period. This

is the only study that

linked anxiety to

long-term mortality

risk after cardiac

surgery.

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Appropriateness and feasibility of music intervention in reducing anxiety

for patients undergoing minor

operative procedures in Accident and

Emergency Department. HKU Theses

Online.

Au, M.Y.

2010.

China.

Emergency care patients.

25

Translational research study investigating use of music in

emergency care patients to help

relieve procedure-related anxiety with

minimal time and cost constraints.

Quasi-experimental.

Level IV.

Researcher utilized translational

nursing research

principles to

describe the

cradle-to-grave

process of

evaluation,

analysis and

implementation of

music intervention

for alleviating

anxiety during

surgical

procedures in

Emergency

Department

patients.

Comprehensive literature review

along with steps

described for

implementation,

staff and patient

education, as well

as follow-up

evaluation of

intervention

effectiveness. STAI

used to assess

anxiety pre and

post-intervention.

Well-written case study of

implementation of

music intervention to

alleviate anxiety in

surgical procedures.

Comprehensive

literature review with

robust, well designed

RCTs.

The effect of music on the human

stress response. PloS One, 8(8),

e70156.

Thoma, M.V.

2013. USA, Switzerland, and Germany.

Female volunteers.

60

Music intervention and effect on

cortisol, alpha-amylase, heart rate,

respiration, subject stress perception

and anxiety.

Between-subjects RCT.

Level II.

Three intervention

conditions were:

relaxing music,

sound of rippling

water, and quiet

rest. Outcomes

evaluated were

salivary cortisol

and alpha-amylase,

heart rate,

respiratory sinus

arrhythmia,

subjective stress

perception and

anxiety, using

BDI, VAS, and

STAI. Stressor

was a two-part

scenario which

included public

speaking and

mathematical

exercises.

Both acoustic

stimuli were

considered relaxing

to subjects. Lowest

levels of cortisol

were found in

music listening

groups. Music

groups experienced

faster autonomic

recovery after

stress intervention.

In laboratory setting

in this study, music

was demonstrated to

attenuate stressful

biochemical

responses. Further

studies need to be

conducted to evaluate

hemodynamic effects

of music listening and

stress response.

Future investigation

should include both

male and female

subjects.

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The efficacy of music therapy. Journal of Perianesthesia

Nursing, 25(4), 226-232.

Wakim, J.H.

2010.

USA.

Meta-analysis Music of varying durations administered in the perioperative

period.

Meta-analysis of quasi-experimental

studies and RCTs.

Level I.

STAI scores, pre- and post-operative

anxiety scores,

VAS anxiety

scores, vital signs

pre- and post-

procedure, narcotic

consumption,

anxiolytic

consumption,

patient

satisfaction, length

of stay, time to

adequate

anesthetic depth,

time to return to

baseline vital signs

after procedure

Music groups experienced

decreased anxiety,

decreased pain,

decreased

medication

consumption for

pain and anxiety,

decreased vital

signs, and

increased patient

satisfaction.

Variability existed

regarding statistical

significance.

Study described 45 different articles that

related the clinical

benefit of using music

in the perioperative

period. Studies all

point to the clinical

benefit, in numerous

end-point measures,

for the surgical

patient. Methodology

differences found,

limitations due to no

randomization or

blinding.

Fifteen-minute music intervention

reduces pre-radiotherapy anxiety in

oncology patients. European Journal

of Oncology Nursing, 17(4), 436-441.

Chen, L.C.

2013.

Taiwan.

Oncology patients in

procedural waiting

area.

200.

15-min of pre-recorded music

administered prior to procedure.

Quasi-experimental, single-blinded

study.

Level II.

STAI scores, pre-

intervention and

post-intervention.

vital signs pre-

intervention and

post-intervention

Music group

experienced

statistically

significant

reductions in

anxiety post-

procedure. Systolic

blood pressure

reduction was

statistically

significant for

music intervention

group.

Study demonstrated

significant

improvement in self-

reported anxiety and

in systolic blood

pressure using just 15

minutes of music on

the day of procedure.

Oncology patients

may experience

heightened baseline

emotional distress

levels, which may

limit generalizability

to day surgery

patients.

Preoperative pain sensitivity and its

correlation with postoperative pain

and analgesic consumption: a

qualitative systematic

review. Anesthesiology, 114(2), 445-

457.

Abrishami, A.

2011.

Canada.

Surgical patients.

Mean sample size

from 15 studies was

54, with a range of

20-165.

Systematic review to identify and

summarize the methods used in the

preoperative assessment of pain

sensitivity and to evaluate the

correlation with postoperative pain,

analgesic consumption, and

occurrence of chronic postop pain.

Meta-analysis.

Level I.

Pain assessment

including pain

threshold,

intensity,

tolerance, and

types of pain

stimuli.

Preoperative pain

sensitivity and its

impact on postop

pain outcomes.

Critical finding: the

response to above

threshold heat pain

could consistently

predict postop pain

outcomes, whereas

no connection was

found between heat

pain tolerance and

postop pain. No

conclusions could

be derived between

electric and

pressure preop pain

stimuli and postop

pain outcomes.

Strengths are that the

article helps identify

the transition point at

which a stimuli

changes from

nonpainful to painful.

This helps quantify

the subjective pain

experience. Female

sex was found to be a

confounding variable,

as well as anxiety and

chronic pain. Main

limitation of the study

is the homogeneity of

the sample.

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Music interventions for preoperative anxiety. Cochrane Database Syst Rev,

6.

Bradt, J.

2013.

USA.

Surgical patients. 2051

All included studies used pre-recorded music listening along with

standard care, as compared to

standard care alone.

Meta-analysis of RCTs.

Level 1.

Music with standard therapy

versus standard

therapy alone

Findings found statistically

significant

reduction in

preoperative

anxiety in

experimental

group, using a

variety of anxiety

assessment tools.

Heart rate and

diastolic blood

pressure were also

reduced. One large

study found

improved

preoperative

anxiety outcome

measures in music

group, as compared

to midazolam

administration.

Large sample size, meta-analysis with

rigorous inclusion

standards. Can be

generalized to all

surgical patients and

strengthens validity of

music interventions in

this population. Main

weakness in study

designs of included

studies were lack of

blinding. Performance

bias and detection

bias were highest risk.

Implementation of music as anesthetic

adjunct during monitored anesthesia

care. Journal of Perianesthesia

Nursing, 25(6), 387-91.

Newman, A.

2010.

USA.

Surgical patients,

scheduled for MAC

anesthesia.

No sample size

reported.

Music as adjunct to anesthesia during

MAC cases.

Literature review and meta-analysis

of RCTs.

Level 1.

Music as

anesthetic adjunct,

effect of music on

BIS values during

MAC sedation,

drug requirements

to achieve

adequate BIS

values for surgical

procedure.

Findings

recommend

implementation of

patient-selected

music selection

during

preoperative,

intraoperative, and

postoperative

phases for MAC

cases. Music as

adjunct led to

decreased

medication

consumption,

decreased time to

adequate anesthetic

level, decreased

anxiety and

decreased pain.

Researchers

developed a useful

protocol for

incorporating patient-

selected music in

anesthetic

management of MAC

cases. However, the

tool needs to be

subjected to scientific

rigor to examine

validity and reliability

in a variety of clinical

settings and

procedures.

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Effects of music on systolic blood pressure, diastolic blood pressure, and

heart rate: a meta-analysis. Indian

Heart Journal, 64(3), 309-313.

Loomba, R.S.

2012.

India.

Patients from a variety of clinical

settings, including

ICU, perioperative

and procedure areas.

659.

Music therapy on vital signs, including heart rate, systolic blood

pressure, and diastolic blood pressure.

Meta-analysis of RCTs.

Level I.

Music as compared to

conventional

treatment.

Systolic blood pressure, diastolic

blood pressure, and

heart rate. Music

was found to be

beneficial in

reduction of vital

signs across a

variety of clinical

settings.

Pooled data can contribute to

erroneous conclusions

based on weak

linkages from studies

of varying designs.

Strengths are that

multiple authors

arrive at the same

conclusion regarding

beneficial effect of

music on vital signs.

Directions for future

studies include larger

sample size in

specific clinical

settings.

The effect of music therapy on

sedative requirements and

hemodynamic parameters in patients

under spinal anesthesia: a prospective

study. Journal of Clinical and

Diagnostic Research, 4(4), 2782-87.

Bansal, P.

2010.

India.

Surgical patients,

undergoing

abdominal,

urological, or lower

extremity surgery

under spinal

anesthesia.

100.

Effect of music and medication

requirements while undergoing

surgical procedures with spinal

anesthesia.

RCT.

Level II.

Two study groups:

headphones with

patient-selected

music and

headphones

without music. All

patients received

spinal anesthesia

in standard

fashion.

No statistical

differences in

midazolam

consumption for

both groups at start

of surgery.

Ongoing sedation

requirements were

lower in the music

group. Music group

required average

0.5 mg of

midazolam, as

compared to no

music group which

required 2.1mg of

midazolam. Mean

pulse rate

significantly lower

in music group.

Anxiolytic medication

and pulse rate were

shown to be

significantly lower in

the music intervention

group. Weakness of

the study was that it

was single-blinded,

due to presence of

headphones and

patients’ request for

selection/volume

changes. The strength

of the study could

have been increased

with plasma cortisol

levels or self-reported

questionnaires.

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Efficacy of music listening as a postoperative pain management

intervention in adult patients: a

systematic review. The JBI Database

of Systematic Reviews and

Implementation Reports, 8(24 Suppl),

S301-319.

Kusi-Amponsah, A.

2010.

United Kingdom.

Adults scheduled for elective major or

minor surgery.

No sample size

reported.

Aim of the study was to analyze and systematically review best available

evidence on the impact of music on

postoperative pain outcomes.

Meta-analysis.

Level I.

Interventions included in meta-

analysis: any

music type of any

duration delivered

immediately after

surgery to POD3

through any

medium, in

addition to

standard care.

Outcomes: postop

pain and analgesic

consumption.

Several recommendations

for practice are

described, for

providing music

interventions

preoperatively,

intraoperatively,

and postoperatively

during the recovery

period.

Provides summary recommendations to

improve perioperative

care using music

interventions to

alleviate patient

perception of pain.

Individual differences in the effects of

music engagement on responses to

painful stimulation. Journal of Pain,

12(12), 1262–1273.

Bradshaw, D.

2011.

USA.

Healthy volunteers.

153.

Effect of music-listening on task-

demand, stimulus-evoked potentials,

pupil dilation, skin conductance

response to noxious stimuli

(indication of central and peripheral

arousal states).

RCT.

Level II.

Volunteers

participated in an

experimental

session where they

received three

stimulus intensity

levels while

listening to

background audio

stimuli, as

compared to

condition 2 which

was performing a

music-listening

task.

Music engagement

reduced pain

perception; anxiety

was found to be a

confounding

variable. Attention

to the task

modulated the

magnitude of the

effect.

Active music listening

was shown to reduce

pain perception, and

those individuals with

anxiety and

absorption into a

stimuli may benefit

from music listening

to help relieve pain.

Study should be

repeated with clinical

pain stimuli.

The Joanna Briggs Institute Best

Practice Information Sheet: music as

an intervention in hospitals. Nursing

& Health Sciences, 13(1), 99.

Joanna Briggs Institute.

2011.

Australia.

Meta-analysis Music intervention for management

of pain, anxiety, and emotional

distress in hospitals.

Meta-analysis.

Level I.

Music intervention

as compared to

standard treatment.

Findings supported

reduced anxiety,

pain, narcotic

consumption with

use of music

interventions

Weak methodology,

poor randomization

and small sample

sizes make meta-

analysis difficult.

Weak quality of

included studies

makes generalization

difficult. Adds

confusion and clouds

the picture for a

minimally accepted

intervention.

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The effectiveness of a generic Guided Imagery CD compared with

individualized complementary

therapies and standard of care for

reducing preoperative anxiety:

preliminary results. The Journal of

Alternative and Complementary

Medicine, 20(5), A137-A137.

Attias, S.

2014.

Israel.

Patients scheduled for surgery.

315.

Comparison of individual complementary medicine treatments,

a generic GI CD and standard care on

preoperative anxiety.

RCT.

Level II.

58 patients in GI group, 41

acupuncture, 41

reflexology, 65

reflexology + GI,

62 generic GI CD,

48 standard care

only. Anxiety was

assessed using

VAS.

The GI patients, reflexology,

reflexology + GI,

and acupuncture

showed statistically

significant

reduction in VAS.

There were no

statistical

differences

between

complementary

therapy groups;

however all were

better than standard

care or GI.

Demonstrated effectiveness of

complementary

therapies in reducing

anxiety.

Randomization and

blinding not described

by authors.

Methodology not

described in detail.

Effects of guided imagery on

postoperative outcomes in patients

undergoing same-day surgical

procedures: a randomized, single-

blind study. AANA, 78(3), 181-188.

Gonzales, E.A.

2010.

USA.

Same-day surgical

patients scheduled

for head and neck

procedures.

44

Guided imagery audio intervention

during perioperative period.

Randomized, quasi-experimental

single-blinded study.

Level II.

Guided imagery

audio intervention

(28-min of

listening to a CD)

as compared to

standard treatment

for preoperative

and perioperative

anxiety.

Statistically

significant

reduction in

anxiety, reduction

in pain at 2 hours

post-procedure, and

an average 9 min

shorter PACU

LOS.

Most significant

finding of this study

is that an audio

relaxation

intervention applied

on the day of surgery

still may confer

statistically

significant reductions

in anxiety and pain.

Limitations include

the culture of the

facility in which all

patients receive

standard anxiety and

pain medications,

which may impact

outcomes of the

study.

The effects of guided imagery on

preoperative anxiety and pain

management in patients undergoing

laparoscopic cholecystectomy in a

multi-centre RCT study. BMC

Complementary and Alternative

Medicine, 12(Supp 1), 184.

Jong, M.

2012.

USA.

Patients scheduled

for laparoscopic

cholecystectomy.

95.

Guided imagery CD given 7 days

prior to surgery.

Multi-center experimental design

RCT.

Level II.

Guided imagery or

standard treatment.

Compliance was

suboptimal.

Morphine use was

lower in guided

imagery

intervention group.

Other variables

were lower, but not

statistically

significant.

Researchers failed to

ensure compliance

with the guided

imagery intervention.

Difficulty in isolating

clinical benefit

associated with

guided imagery, due

to extended study

period, 7 days prior to

surgery. High attrition

rates due to

cancellations/schedule

changes.

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A pilot study to assess the effects of a guided imagery audiotape intervention

on psychological outcomes in patients

undergoing coronary artery bypass

graft surgery. Holistic Nursing

Practice, 24(4), 213-222.

Stein, T.R.

2010.

USA.

Patients scheduled for CABG.

138.

Aimed to assess the effectiveness of a GI audiotape intervention for CABG

patients to help minimize

psychological distress

postoperatively.

RCT.

Level II.

Depression and anxiety were

assessed using

HADS. Subjects

were randomized

to one of three

groups: music,

guided imagery, or

standard care.

Guided imagery

was “Successful

Surgery” by

Health Journeys.

No significant relationship

between patients’ 1

week or 6 month

postoperative

distress and pre-

and intraoperative

use of GI was

found.

First RCT to examine whether a brief GI or

music intervention

would alleviate

emotional distress in

CABG patients. May

be difficult to

evaluate emotional

variables in CABG

patients due to

complexity of disease,

lifestyle changes and

recovery. Study

showed that GI was

palatable to a sample

of older adults. Future

studies should have a

larger sample.

An evidence-based review on guided

imagery utilization in adult cardiac

surgery. Clinical Scholars

Review, 3(1), 22-30.

Casida, J.

2010.

USA.

Meta-analysis of

cardiac surgery

patients. 7 articles

selected for review.

Comprehensive review of best

available evidence surrounding GI in

cardiac surgery patients.

Meta-analysis.

Level I.

Outcomes of

interest were

emotional distress,

hospital length of

stay, pre and

postop tension,

anxiety and pain.

GI may help to

reduce pain,

anxiety, tension,

and hospital LOS

in CABG patients.

Further research is

warranted to

strengthen

scientific rigor of

GI studies.

Articles had

weaknesses in study

design, blinding,

randomization, and

questionable validity.

Calls attention to

weaknesses in

scientific evaluation

of GI.

Feasibility trial of guided imagery and

control interventions in mock

subjects. Applied Nursing

Research, 24(1), 45-52.

Jacobsen, A.F.

2011.

USA.

Volunteers.

20.

Determine whether listening to audio

books or GI interventions were

comparable, and feasibility of audio

interventions.

Qualitative non-experimental.

Level V.

Intervention -

30min of self-

directed audio

intervention (GI or

AB) for a 2-week

period. Daily

journal entries,

exit interview, and

11-item

intervention

evaluation were

measured

outcomes.

Participant

reactions,

thoughts, and

feelings were

analyzed.

Respondents

described the time

of day and location

where they

participated in the

intervention as

significant impact

on their feelings

towards the

intervention.

Non-experimental

design, difficult to

draw conclusions

from. Establishes a

starting point for

experimental designs

and structure of RCTs

for GI, including an

appropriate control

group of audio books.

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The Effectiveness of Interventions Aimed at Reducing Anxiety in Health

Care Waiting Spaces: A Systematic

Review of Randomized and

Nonrandomized Trials. Anesthesia &

Analgesia, 119(2), 433-448.

Biddiss, E.

2014.

Canada.

Subjects from hospital waiting

areas in 41 studies.

33 adult samples and

8 pediatric samples.

1129.

Meta-analysis of interventions aimed at reducing anxiety in health care

waiting areas.

Meta-analysis.

Level I.

Music, aromatherapy,

interior design for

adults. Play,

distraction, and

music for pediatric

subjects.

Outcomes was

anxiety as

measured using

STAI.

Music was the only intervention with

statistically

significant

consistent

reductions in

anxiety scores.

Inconclusive

findings reported

for pediatric

subjects.

Comprehensive evaluation of most

effective interventions

for clinicians to target

efforts at reducing

anxiety while waiting.

Would have been

beneficial to separate

adult and pediatric

subjects.

A portable immersive system as an

alternative medical treatment to

reduce anxiety in minor surgical

operations: a randomized controlled

study. Virtual Worlds, Real Healing,

125.

Gorini, A.

2010.

Mexico.

Surgical patients,

scheduled for

procedures requiring

local or regional

anesthesia.

47.

Effect of virtual reality (VR), music

(M) or standard care on anxiety

levels, hemodynamic variables.

RCT.

Level II.

VR group wore a

head-mounted

display goggle

plus headphones

depicting an

immersive nature

experience, M

group listened to

relaxing music,

and standard group

received no audio

or video

stimulation.

Statistically lower

anxiety reported in

VR and M groups.

Decreased heart

rate observed in

both VR and M

groups. Onset to

anxiety reduction

was 45 min faster

in VR group than

M group.

Findings support use

of Virtual Reality

technology in

alleviating anxiety.

Demonstrates efficacy

of a cost-effective

alternative to sedation

medications. Subjects

received no additional

IV medication and

tolerated the

procedure under local

only. Further studies

should include visual

stimuli in relaxation

interventions.

Effectiveness of different music-

playing devices for reducing

preoperative anxiety: a clinical control

study. International journal of nursing

studies, 48(10), 1180-1187.

Lee, K.C.

2011.

Taiwan.

Day-surgery patients

waiting in the

surgery waiting area.

167.

Relaxation music delivered via

headset or broadcast speaker, as

compared to quiet waiting period.

RCT.

Level II.

Comparison

between

broadcasted music

and music

delivered via

headphones and

MP3 player. Both

types of music

were pre-recorded

and a specific beat,

tempo, and style of

music. Non-

intervention group

waited in silent

area without

music. All patients

had option to

receive standard

Although not

statistically

significant,

anxiety-VAS

scores were lower

for both music

playing

intervention groups

than for the no-

intervention group.

There was no way to

conduct pre-

intervention and post-

intervention testing,

due to the broadcast

intervention group. If

the subjects arrived in

the middle of a song

in the broadcast

group, it would be

difficult to assess

baseline values. Also,

the groups were not

blinded.

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The effect of using a relaxation tape on pulse, respiration, blood pressure

and anxiety levels of surgical

patients. Journal of clinical

nursing, 21(5‐ 6), 689-697.

Ko, Y.L.

2012.

Taiwan.

Surgical patients. 80.

Effect of listening to relaxation tape on vital signs and self-reported

anxiety.

Pre- and post-test quasi-experimental

design.

Level III.

Participants had baseline data

collected, vital

signs and anxiety,

before and after a

relaxation audio

tape.

Vital signs and anxiety scores

statistically

reduced after

listening to the

intervention.

Measuring data immediately before

and after the

intervention may bias

subjects to respond in

the expected manner

to the intervention.

Further research

should focus on

repeating the

intervention to

determine point at

which maximal

benefit occurs.

A brief relaxation intervention reduces

stress and improves surgical wound

healing response: a randomized trial.

Brain, behavior, and immunity, 26(2),

212-217.

Broadbent, E.

2012.

New Zealand.

Surgical patients

scheduled for

laparoscopic

cholecystectomy.

75.

Impact of relaxation intervention on

surgical wound healing, as measured

by hydroxyproline deposits in wound.

RCT.

Level II.

Relaxation

intervention was

described as 45-

min face to face

visit with

psychologist who

instructed on deep

breathing and

scripted readings

of deep breathing,

muscle relaxation

and guided

imagery. Outcome

of interest was

hydroxyproline

presence around

wound sites, an

amino acid and

cellular marker of

collagen synthesis.

Stress was

measured using the

Perceived Stress

Scale (PSS).

Older age patients

reported greater

stress reduction.

Intervention group

reported greater

stress reduction

than control.

Intervention group

had improved

wound healing, as

measured by

hydroxyproline at

wound sites.

Serum measures of

collagen deposition

are in line with

previous work on

stress and wound

healing. A larger

sample size may

increase

generalizability of

findings.

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An evaluation of the effectiveness of relaxation therapy for patients

receiving joint replacement

surgery. Journal of clinical

nursing, 21(5‐ 6), 601-608.

Lin, P.C.

2012.

Taiwan.

Patients scheduled for total joint

surgery.

93.

Effect of relaxation intervention on pain, anxiety, and healing in joint

replacement patients.

Quasi-experimental pre- and post-

intervention design.

Level III.

Patients in intervention group

received relaxation

and breathing

training using a

pre-recorded audio

tape. Outcomes

measured were

anxiety, measured

with STAI and

VAS, pain (VAS)

and self-reported

questionnaire.

Pain was reduced in experimental

group on night of

surgery and POD1,

however on POD2

and POD3 no

differences were

observed. Anxiety

on evening of

surgery was still

reported as

moderate, for both

groups.

Anxiety was not improved with use of

intervention. Pain was

reported to be

lowered in the

intervention group,

which indicates a role

for mind-body

preparation in pain

reduction. Limitations

were small sample

size and older age.

The role of anxiolytic premedication

in reducing preoperative

anxiety. British Journal of

Nursing, 21(8), 479-483.

Carroll, J.K.

2012.

Ireland.

Surgical patients.

1115.

Evaluation of baseline anxiety and

treatment with anxiolytic medications

in holding area.

RCT.

Level II.

Anxiety

assessments were

conducted before

and after

administration of

anxiolytic

medications.

Of total sample,

66% responded

with moderate

anxiety levels;

however only 4%

received anxiolytic

medications before

transport to the

operating theater.

Study describes

underutilization of

anxiolytic therapies.

May point at gaps in

awareness and

assessment of anxiety

in surgical

populations. Further

study should be

conducted in larger

sample, in the US.

Use of nonpharmacologic

interventions for pain and anxiety after

total hip and total knee arthroplasty.

Orthopaedic Nursing, 24(3), 182-190.

Pellino, T.A.

2005.

USA.

Patients scheduled

for total joint

replacement.

65.

Comparison of standard care to non-

phamacological options for pain,

anxiety and narcotic consumption in

orthopedic patients.

Retrospective review.

Level IV.

Patient-selected

non-

pharmacological

interventions were

employed to aid in

pain and anxiety

reduction in total

joint art hroplasty

patients. Patient

outcomes included

pain, anxiety,

medication

consumption,

LOS. Chart

reviews were used

to collect data.

Patients who

received non-

pharmacological

interventions

experienced less

anxiety and

required less

pharmacological

treatments.

Demonstrates

effectiveness of non-

pharmacological

treatments for anxiety

and pain reduction in

surgery patients. No

participation bias in

retrospective chart

audits; however risk

of inconsistent

treatment protocols.

Needs to be repeated

in a RCT

experimental design.

Key to Evidence Levels: Level I Evidence From systematic review or meta-analysis of all relevant randomized controlled trials (RCT’s),

or evidence-based clinical practice guidelines based on systematic reviews of RCT’s Level II Evidence From at least one well-designed RCT Level III Evidence From well-designed controlled trials without randomization Level IV Evidence From well-designed case-control and cohort studies Level V Evidence From systematic reviews of descriptive and qualitative studies Level VI Evidence From single descriptive or qualitative study Level VII Evidence From the opinion of authorities and/or reports of expert committees

Adapted from Melnyk, & Fineout-Overholt (2005). Evidence-based practice in nursing and healthcare: A guide to best practice, Rating system for the Hierarchy of Evidence, page 10.

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APPENDIX B

TEXAS WOMAN’S UNIVERSITY CONSENT TO PARTICIPATE IN RESEARCH

Title: Pilot Study to Evaluate Effect of Audio Relaxation Intervention on Pain, Anxiety, and

Patient Satisfaction in Surgical Patients at a Community Hospital

Investigator: Tanya Island, CRNA ............................................. [email protected] 832/875-3703

Advisor: Charli Oquin, DNP ....................................................... [email protected] 214/689-6568

Explanation and Purpose of the Research

You are being asked to participate in a research study for Tanya Island, CRNA at Memorial

Hermann Hospital – First Colony. The purpose of this research is to determine if listening to

relaxing music before and after outpatient surgery affects pain, anxiety, and patient satisfaction.

You have been asked to participate in this study because you are having outpatient surgery

today.

Description of Procedures

As a participant in this study you will be asked to spend 5-15 minutes of your time in a face-to-

face interview with the researcher. The researcher will provide a brief description of how to

use the headset and MP3 player. You will be advised to listen to the relaxation music, at your

discretion, for the entire duration of your wait in the preoperative holding area. Once you wake

up from anesthesia and rest in the Post-Anesthesia Care Unit (PACU), you will also be offered

the relaxation headset. Your pain and anxiety scores will be collected, via electronic charting,

before and after surgery. In order to be a participant in this study, you must be at least 18 years

of age, free of chronic pain or anxiety disorders, and having outpatient surgery.


Potential Risks

The researcher will ask you questions about your pain and anxiety history, similar to other

questions in the standard pre-anesthesia interview. A potential risk involves loss of privacy

with answering these questions. A possible risk in this study is discomfort with the headset or

the music volume. The audio intervention is directed by you and at your own pace. If at any

time you choose to stop listening to the music, you can simply turn off the MP3 player. Another

potential risk is excess sleepiness or fatigue after listening to the intervention. If you are not

comfortable with the relaxed state, you can simply turn off the MP3 player. Decontamination of

all headsets will be conducted prior to use with standard cleaning solutions. However, there is a

risk of contamination from using equipment from other patients. This risk is the same for other

pieces of reusable hospital equipment, such as blood pressure cuffs.

The results of the study will be reported in scientific magazines or journals but your name or

any other identifying information will not be included.

The researchers will try to prevent any problem that could happen because of this research. You

should let the researcher know at once if there is a problem. The research team will help you

resolve your concerns. However, TWU does not provide medical services or financial

assistance for injuries that might happen because you are taking part in this research.

_____________

Initials

Page 1 of 2


Participation and Benefits

Your involvement in this study is completely voluntary and you may withdraw from the study

at any time. If you would like to know the results of this study we will e-mail or mail them to

you. Please provide your contact information at the end of this consent form, so that we may

provide you with results.

Questions Regarding the Study

You will be given a copy of this signed and dated consent form to keep. If you have any questions about

the research study you should ask Tanya Island, CRNA; her phone number is at the top of this form. If

you have questions about your rights as a participant in this research or the way this study has been

conducted, you may contact the Texas Woman’s University Office of Research and Sponsored Programs

at 940-898-3378 or via e-mail at [email protected].

_______________________________________________________ _______________

Signature of Participant Date

_______________________________________________________ _______________

Signature of Researcher Date

If you would like to know the results of this study tell us where you want them to be sent:

Email: __________________________

Electronic format is preferred by the research team. However, if you do not have an email address, please provide

your mailing address.

Mailing Address:

________________________________

________________________________

_________________________________ Page 2 of 2


Appendix C


Appendix D

STUDY DATA TOOL Anxiety Assessment Scale (APAIS) NOT AT ALL EXTREMELY

1. I am worried about the anesthetic. 1 2 3 4 5

2. The anesthetic is on my mind continually. 1 2 3 4 5

3. I would like to know as much as possible 1 2 3 4 5

about the anesthetic.

4. I am worried about the procedure 1 2 3 4 5

5. The procedure is on my mind continually. 1 2 3 4 5

6. I would like to know as much as possible 1 2 3 4 5

about the procedure.

Anesthesia – related anxiety: SUM A = 1 + 2 _______________________

Surgery – related anxiety: SUM S = 4+5 _______________________

Desire for information: SUM 3+6 _______________________

Combined anxiety: SUM A + SUM S = 1+2+4+5 _______________________

Pain Assessment – On a scale of 0 to 100, with 0 being no pain and 100 being the worst pain you’ve

ever experienced, what is your pain at the current moment?

_______________________

Anxiety Assessment – On a scale of 0 to 100, with 0 being no anxiety and 100 being the worst anxiety

you’ve ever experienced, what is your anxiety at the current moment?

_______________________

FOR POSTOP PATIENTS:

Did you listen to the Guided Imagery tracks or a local radio broadcast of your choice?

GI or FM

List all anxiolytic and narcotic medications and dosages used during perioperative care:

Would you recommend the audio intervention you used today to other friends and family?

YES or NO

Please rate your satisfaction with the audio intervention on a scale of 1 to 5

Not at all Extremely

1 2 3 4 5

pilot study to evaluate efficacy of a self-directed audio intervention on pain...

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