clinical hypnosis: a strategy to modify pain impact and depression in sickle cell patients · 2012....
TRANSCRIPT
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Clinical Hypnosis: A Strategy to Modify Pain Impact and Depression
in Sickle Cell Patients
Gwenyth R. Wallen, RN, PhD
Nursing Research and Translational Science
National Institutes of Health, Clinical Center
Bethesda, MD
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Kimberly R. Middleton, BSN, MPH
Sinthujah. Velummylum, BSAlyssa Todaro, BS
Nancy Ames, RN, PhDClaiborne Miller-Davis, RN
MSChad Koratich, RN, MSMichael Krumlauf, BSN
Daniel Handel, MD
Co-authors:
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Background• Sickle cell disease (SCD) is the most
common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises.
• Standard medical therapies to control or prevent crises are limited because of efficacy and/or toxicity.
• Sickle-shaped cells which are stiff and distorted in shape, have difficulty passing through small blood vessels and block blood from reaching parts of the body.
• Tissue that does not receive a normal blood flow eventually becomes damaged, which causes the complications and pain “crises”typical of sickle cell disease.
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Background• Historically, standard medical therapies for controlling
painful vaso-occlusive crises in patients with sickle cell disease were limited to opioid administration.
• Published studies often focus on the frequency of acute pain crises resulting in emergency department use and hospitalizations.
• Few studies focus on pain manifestations occurring outside the healthcare delivery system. The proportion of patients who are able to self-manage their crises at home is unknown.
• The impact mind-body interventions such as hypnosis may have on physical and emotional suffering remains unclear.
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Methods• We conducted a randomized, controlled pilot study of
hypnosis with outpatient SCD patients (n=31).
• Sixteen participants were randomized to the control group and fifteen to the treatment arm of the study.
• Participants in the treatment arm received guided hypnosis during 4 weeks of face-to-face encounters with a credentialed therapist followed by 6 weeks of self-hypnosis using a customized DVD.
• Participants in the control arm of the study received face-to-face education on SCD for the same length and frequency.
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Intake Interview and Begin Daily Diaries for 1 week
Randomization Begin Intervention (1 week
after Consent)
Yes
End of studyNo
CONTROL HYPNOSIS ARM
End of study
Face-to-face Outcomes Assessment
(qW
kx
4 w
ks)
(qW
kx
4 w
ks)
(6 wks)(6 wks with Education DVD)
Education Hetero-hypnosis
Self-hypnosis DVD
crossover
Eligible for Study?
Hypnotic Susceptibility Assessment
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Hypnosis
Hypnosis is described as a state of inner absorption, concentration and focused attention. The hypnosis therapist acts as a teacher who guides the process of relaxation into a comfortable state, it appears to help with a variety of health conditions, like pain or easing symptoms of asthma.
Following hypnotic training, most people can effectively perform self-hypnosis. Self-hypnosis can be used to better manage pain and other symptoms such as difficulty sleeping.
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Hypnosis DVD
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Education Modules
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Patient Reported Outcomes
• Pain frequency and intensity [NRS] • Pain Impact Scale [PIQ] • State-Trait Anxiety Inventory [STAI State and STAI
trait] • Coping Strategies Questionnaire [CSQ] • Pittsburgh Sleep Quality Index [PSQI] • Beck Depression Inventory [BDI] • Stanford Hypnotic Clinical Scale for Adults was
utilized to measure hypnosis susceptibility.• Daily Diaries
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Statistical Analysis
• Descriptive statistics and nonparametric tests including Spearman Rho correlation analyses for interval data and Mann Whitney U for categorical data will be presented.
• A nonparametric Friedman test was conducted comparing the differences within groups across time.
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Totaln=31
Experimental n=15
Controln=16
n (%) n N
GENDERMale 16 (51.6%) 6 10Female 15 (48.4%) 9 6
AGE18-36 years of age 19 (61.3%) 8 1137-57 years of age 12 (38.7%) 7 5Mean Age, years(SD): 36.2 ± 11.8 37.7 ± 13.6 34.7 ± 10.0
ETHNICITYHispanic 2 (6.5%) 1 1Non Hispanic 29 (93.5%) 14 15
RACEBlack/African American 25 (80.6%) 12 13American Indian/Alaskan Native 1 (3.2%) 0 1Other 5 (16.1%) 3 2
EDUCATIONHigh school or some college 21 (67.7%) 10 11Graduate or post-graduate 10 (32.3%) 5 5
MARITAL STATUSMarried 7 (22.6%) 3 4Not Married 24 (77.4%) 12 12
OCCUPATIONAL STATUSEmployedUnemployedStudent
8212
(25.8%)(67.7%)(6.5%)
5100
3112
*Comparisons using Fisher's exact test (sample too small for chi-square) show no statistical difference for the measures shown.
Demographic Measures by Group
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Outcome Measures by Group
Totaln=31
Experimental n=15
Controln=16
Mean (±SD) Mean (±SD) Mean (±SD)
PAIN INTENSITY (NRS)Possible range 0-10, Actual Range: 0-8
2.7 (± 2.3) 3.0 (± 2.6) 2.3(± 1.9)
PAIN IMPACT SCALEPossible range 40-78, Actual Range: 48-72
62.0 (± 6.7) 62.8 (± 6.5) 61.3 (± 7.1)
BECK’S DEPRESSION INDEX Possible range 0-63, Actual Range: 0-25
11.0 (± 6.3) 10.7 (± 7.0) 11.3 (± 5.8)
PITTSBURG SLEEP QUALITY INDEXPossible range 0-21, Actual Range: 2-16
9.6 (± 3.9) 9.2 (± 3.6) 10.0 (± 4.3)
STATE-TRAIT ANXIETY INDEX-statePossible range 20-80, Actual Range: 20-57
32.5 (± 9.6) 32.3 (± 10.1) 32.8 (± 9.4)
STATE-TRAIT ANXIETY INDEX-traitPossible range 20-80, Actual Range: 20-60
36.1 (± 10.2) 35.9 (± 9.5) 36.3 (± 11.2)
COPING STRATEGIES INDEXPossible range 0-300, Actual Range: 53-209
138.8 (± 41.6) 141.1 (± 43.7) 136.6 (± 40.8)
HYPNOSIS SUSCEPTIBILITY (n=16)Possible range 2-5
4.0 (± 1.0) 3.9 (± 1.2) 4.2 (± 0.4)
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Spearman’s rho Non-parametric Correlations
Pain Intensity
Pain Impact BDI STAI-State STAI-Trait
Pain Intensity
Pain Impact 0.412*
BDI 0.218 0.378*
STAI-State -0.112 0.009 0.456*
STAI-Trait 0.051 0.202 0.694** 0.770**
CSQ 0.331 0.264 0.108 -0.245 -0.113
PSQI -0.085 -0.029 0.430* 0.217 0.361*
#comorbid 0.316 0.050 0.014 -0.047 0.033
#meds 0.382* 0.086 0.257 -0.052 0.196
**significant at p≤ .01 level (2-tailed)* significant at p ≤ .05 level (2-tailed)
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CSQ PSQI #comorbids #meds
Pain Intensity 0.331 -0.085 0.316 0.382*
Pain Impact 0.264 -0.029 0.050 0.086
BDI 0.108 0.430* 0.014 0.257
STAI-State -0.245 0.217 -0.047 -0.052
STAI-Trait -0.113 0.361* 0.033 0.196
CSQ -0.045 0.273 0.223
PSQI -0.025 0.160
#comorbid 0.674**
#meds
**significant at p≤ .01 level (2-tailed)* significant at p ≤ .05 level (2-tailed)
Spearman’s rho Non-parametric Correlations (cont’d)
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Friedman Test (compares the mean ranks across time)Variable N Χ2 test p-value
Hypnosis
NRS 9 2.16 .34
PIQ 10 6.05 .048*
BDI 10 10.07 .007**
STAI Total 10 4.00 .14
STAI State 10 4.92 .09
STAI Trait 10 5.69 .06
CSQ 10 2.51 .29
PSQI 9 1.88 .39
Control
NRS 12 1.09 .58
PIQ 12 5.20 .07
BDI 11 3.15 .21
STAI Total 12 1.20 .55
STAI State 12 1.40 .50
STAI Trait 12 2.26 .32
CSQ 12 3.87 .14
PSQI 12 1.86 .40*p
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Results• There was a significant difference across time in the
hypnosis group for PIQ (p=0.048) and BDI (p=0.007). – Post-hoc analysis (Wilcoxon signed-rank tests) with a
Bonferroni adjustment, indicated there was a significant difference in the PIQ between baseline and week 12 (p=.017), but not between baseline and week 5 or between week 5 and week 12.
– The week 12 BDI scores were lower than baseline and week 5.
• There were no significant differences in the control group.
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Conclusions
• Preliminary results suggest a link between depression, sleep quality and anxiety in this patient population.
• Hypnosis is a promising new tool as an adjunct mind-body intervention to reduce pain impact and for increasing pain coping strategies.
• Further studies with larger sample sizes are needed.