RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

“A STUDY TO ASSESS THE EFFECTIVENESS OF SOYA MILK CONSUMPTION ON REDUCTION

OF HOT FLASH AMONG PERIMENOPAUSAL WOMEN IN SELECTED URBAN AREAS AT

MYSORE”

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

Ms. ANUMOL MATHEWS

1st YEAR M.Sc NURSING

OBSTETRICS AND GYNAECOLOGICAL NURSING

GOPALA GOWDA SHANTHAVERI MEMORIAL COLLEGE OF NURSING

T.N. PURA ROAD, NAZARBAD

MYSORE-570 010

KARNATAKA

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

PROFORMA FOR SYNOPSIS REGISTRATION OF SUBJEECT FOR DISSERTATION

1.1 1. Name of the Candidate and Address Ms. ANUMOL MATHEWS

M.Sc. NURSING 1ST YEAR,

GOPALA GOWDA SHANTHAVERI

MEMORIAL COLLEGE OF NURSING,

T.N PURA ROAD, NAZARBAD,

MYSORE – 570 010

2.2 2. Name of the Institution Gopala Gowda Shanthaveri Memorial College Of Nursing,

Mysore.

3. 3. Course of study and subject 1st Year M.Sc Nursing,

Obstetrics and Gynaecological Nursing.

4. 4. Date of admission to course 28-06- 2012

5. 5. Title of the Topic:

“The Effectiveness of Soya Milk Consumption on Reduction of Hot Flash Among Perimenopausal

Women”.

6. 6.

Brief resume of the intended work:

6.1 Need for the study

6.2 Review of literature

6.3 Objectives of the study

6.4 Operational definitions

6.5 Hypotheses of the study

6.6 Assumptions

6.7 Delimitations of the study

6.8 Pilot study

6.9 Variables

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

1.1 7. Materials and methods:

7.1 Source of data collection: the data will be collected from perimenopausal women aged above 40 years and who have not attained menopause with hot flash in selected urban areas at Mysore.

7.2 Method of data collection: prior to data collection permission will be obtained from the concerned

authority of urban areas for conducting the study. The perimenopausal women aged above 40 years and

who have not attained menopause with hot flash will be selected by inclusion criteria. Informed consent

will be obtained from the perimenopausal women. Then assess the level of hot flash among by using

modified menopausal rating scale and soya milk will be administered to experimental group. The

effectiveness of soya milk consumption on reduction of hot flash will be assessed in experimental group

and will be compared the effectiveness among experimental and control group.

7.3 Does the study require any interventions or investigations to the patients or other human

being or animals?

YES, soya milk will be administered orally to perimenopausal women aged above 40 years and who

have not attained menopause with hot flash.

7.4 Has ethical clearance been obtained from your institutions?

YES, ethical committee’s clearance has been obtained.

2.2 8. List of references Enclosed

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the candidate and Address Ms. ANUMOL MATHEWS

M.Sc. NURSING 1ST YEAR,

GOPALA GOWDA SHANTHAVERI MEMORIAL COLLEGE

OF NURSING,

T.N PURA ROAD, NAZARBAD,

MYSORE- 570 010

2. Name of the institution Gopala Gowda Shanthaveri Memorial College Of Nursing,

Mysore.

3. Course of study and subject 1st year M.Sc nursing,

Obstetrics and Gynaecological Nursing.

4. Date of admission to course 28-06-2012

5. Title of the topic “The Effectiveness of Soya Milk Consumption on Reduction of

Hot Flash Among Perimenopausal Women”.

6. BRIEF RESUME OF THE INTENDED WORK:

INTRODUCTION

“Women is a miracle of divine contradictions”

- Jules Michelet.

Being a woman is very special. Women experience various turning points in their life cycle, which may

be developmental or transitional. The transitional changes of a girl start when she attains a menarche. Thus a girl

transformed to a women. Similarly another vital event in women is pregnancy and childbirth, where the women

become the mother –the revolutionary act. At last woman will reach the stage of menopause in which various

physiological as well as psychological changes will takes place. But these are usually neglected by most of the

women.

Menopause means permanent cessation of menstruation at the end of reproductive life due to

loss of ovarian follicular activity. It is the point of time when last and final menstruation occurs. The

age of menopause ranges between 45-55 years average being 50years.1 The word “menopause” literally means

the "end of monthly cycles" (the end of monthly periods or menstruation), from

the Greek word pausis (cessation) and the root men- (month).2

The stages of the menopause have been classified into premenopausal, post menopausal and

perimenopausal. Perimenopausal period describes the years both before and after the final period. During

perimenopausal period, the ovarian production of the estrogen and progesterone becomes more irregular, often

with wide and unpredictable fluctuations in their levels, FSH level increases until months after the last menstrual

period, fertility diminishes and menses become more irregular.3

In the developed world, mean life expectancy for women since 1990 has increased from 50 to 81 years.

The life expectancy of the population around the world is estimated to be 75-80 years. Today, there are over 200

million postmenopausal women worldwide and 40 million in India. According to the world health organization

they estimated that by 2025 there will be 1.1 billion women above the age of 50 years experiencing menopause

and the average age of experiencing the symptoms of menopause is 47.5years.4 In India as per the 2007 reports,

the mean age at menopause ranges from 40.32 to 48.48 years. 5

The most common and the noticeable symptom of menopause is hot flash or hot flush. Hot flash and

sweating are the hallmark of the climacteric in 85% of women, other symptoms include severe sweating,

headache, disturbed sleep, palpitation, anginal pain, irritability, lack of concentration ,cancer phobia, dry

vagina, loss of libido, osteoporosis, sensation pains and needles in the extremity ,urinary symptoms like

dysuria, stress incontinence, urge, recurrent infection etc.6

Hot flash is the characteristic symptom in perimenopause. It is thought to be due to a combination of

hormonal and biochemical fluctuations brought on by declining estrogen levels. A hot flash is a feeling of

warmth spreading over the body that is often most strongly felt in the head and neck regions. Hot flashes may be

accompanied by perspiration or flushing and usually last from 30 seconds to several minutes up to 40% of

regularly menstruating women in their 40’s report having hot flashes. About 80% of women will be finished

having hot flashes after five years, but sometimes they may persist for a longer time period. Hot flashes can

sometimes be accompanied by night sweats (episodes of drenching sweats occurring at night time).7

Soybean is commonly called wonder bean since it is an excellent source of nutrients such as proteins,

fats, carbohydrates, vitamins and minerals. It contains 43 gm of protein per 100 gm which is the highest among

the pulses. It also contains 19.5 gm of fat, 21 gm of carbohydrate and provides 432 kcal per 100gm Soybean also

contains a family of chemical compounds called phytoestrogens. Phytoestrogens have chemical structures similar

to the estrogens produced in the body and it is believed that eating foods rich in phytoestrogens can help alleviate

low estrogen production in the body. Isoflavones are the active ingredients in soybeans which have estrogen like

properties. Isoflavones reduces menopausal symptoms, blood cholesterol level, incidence of cancer and

osteoporosis. Eating 100gm of soya protein per day provides 200 mg of soya isoflavones. A target range of 80-

160 mg of isoflavones per day is needed for adequate relief of menopausal symptoms. All the products of

soybean are of dietary importance such as soybean cheese, soybean milk, soybean oil and soybean meal.8

"Researchers have found that women in Japan and other Asian countries, who eat 35 to 45 milligrams of

plant estrogens a day in the form of tofu, soy milk and other soy products, seems to experience fewer hot flashes.

The study revealed by The Department of Family Medicine and Community Health at Tufts University School of

Medicine in Boston. Researchers in Australia found that menopausal women who ate soy flour daily for 12

weeks showed a 40 percent decrease in hot flashes.9

A plenty of data that shows soy’s health benefits on menopause symptoms relief. The phytoestrogens

such as soy isoflavones are capable of binding to estrogen receptors (ER) to downgrade the effects of excess

estrogen when levels are high or to exert a weakly pro-estrogenic effect when levels are low. An interesting note

in the research is that phytoestrogens do not seem to cause cells to proliferate as steroid estrogens can under

certain circumstances. FDA has recommended adding 45 to 100 mg of soya diet in a day is beneficial to alleviate

menopausal symptoms mainly hot flash.10

6.1 NEED FOR THE STUDY

“Woman is the glory of creation". Nature takes her through a series of transitions from her birth until

death, which includes menarche, pregnancy, labour, motherhood and menopause. Each of these stages stands for

different phases in her life which includes both physical and/or psychological changes. Menopause is the time in

a woman's life when the function of the ovaries ceases. Perimenopause means "the time around menopause" and

is often used to refer to the menopausal transitional period.

The median age at menopause in Europe ranges from 50.1 to 52.8 years, in North America from 50.5 to

51.4 years, in Latin America from 43.8 to 53 years and in Asia from 42.1 to 49.5 years. The frequency of

vasomotor symptoms such as hot flash varies widely depending on the geographical region, selection of criteria,

and method of symptom identification. The prevalence of such symptoms ranges from 74% of women in Europe,

36–50% in North America, 45–69% in Latin America and 22–63% in Asia, as reported in different, large,

epidemiological studies.11

For the majority of women, the perimenopause will last not more than a couple of years, although others

experience symptoms for as long as five or six years. In that 15% of women have no problems when their

periods cease, whereas 70% of women experience some symptoms and changes. The decline in the release of

oestrogen and progesterone which begins a few years before menstruation stops, leading to some uncomfortable

physical symptoms, which includes hot flushes , night sweats , irregular, scant or heavy periods, dry or itchy

skin, aches and pain, insomnia, tiredness and lethargy, bladder problems, loss of vaginal elasticity, dizziness,

swollen ankles and palpitations. In which hot flashes are the most frequent symptoms of menopause and

perimenopause.12

Hot flashes typically begin as a sudden sensation of heat centered on the face and upper chest that rapidly

becomes generalized. The sensation of heat lasts between two and four minutes, is often associated with profuse

perspiration and occasionally palpitations and is often followed by chills and shivering. Physiologic studies have

determined that hot flashes represent thermoregulatory dysfunction; there is inappropriate peripheral

vasodilatation with increased digital and cutaneous blood flow and perspiration resulting in rapid heat loss and a

decrease in core body temperature below normal. Shivering then occurs as a normal mechanism to restore the

core temperature to normal. Hot flashes usually occur several times per day, although the range may be from

only one or two each day to as many as one per hour during the day and night. They cause arousal from sleep,

leading to sleep disturbances.13

A population based survey was carried out on a representative sample of 495 Singaporean migrant

women aged 40 to 60 to determine the prevalence of 17 menopausal symptoms. The mean age of participants

was 49 year and the classical menopausal symptoms found were hot flushes (17.6%), vaginal dryness (20.7%)

and night sweats (8.9%). The most well-known effect of these is the "hot flash" or "hot flush", a sudden

temporary increase in body temperature. These symptoms were reported due to hormonal changes underlying

menopause, which are caused by aging, other health status, psychosocial factors and life style.14

Although menopause is natural process, almost all women during and after the menopause suffer from

typical symptoms with approximately 40% seeking a medical help for various symptoms like vasomotor,

psychological, urogenital, musculoskeletal symptoms. Recent studies failed to show the protective effect of

hormone replacement therapy in reducing the risk of coronary artery disease and have revealed an increased risk

of heart disease, stroke and invasive breast cancer. 15 Certain foods which are in estrogen supplements helps in

reducing the menopausal symptoms mainly hot flushes.16

The dietary supplements like soya beans, wild yam and vitamin E like green leafy vegetables, nuts and

almonds, as well as plenty of mineral and fibre-rich foods, like whole grains and fresh vegetables and water

helps in reducing menopausal symptoms like, hot flushes.17 Soya contains special chemicals known as

phytochemicals that seems to fight against illness and disease. Phytoestrogen, a special kind of phytochemical,

appear in high quantities in soya products. These phytoestrogens are a weaker form of our own natural estrogen,

and seem to help combat the symptoms of menopause. A particularly beneficial type of soya estrogen is the

isoflavone.18

A systematic review and meta-analysis of randomized controlled trials were conducted among

perimenopausal and postmenopausal women to investigate the influence of extracted or synthesized soya bean

isoflavones on reduction of menopausal hot flash frequency and severity. From 277 potentially relevant

publications, 19 trials were included in the systematic review and 17 trials were selected for meta-analyses to

clarify the effect of soybean isoflavones on hot flash frequency and severity. Meta-analysis revealed that

ingestion of soy isoflavones for 6 weeks to 12 months significantly reduced the frequency of hot flashes (P <

0.00001).The results showed that Soy isoflavone supplements, derived by extraction or chemical synthesis, are

significantly more effective than placebo in reducing the frequency and severity of hot flashes.19

Japanese women have a much lower incidence of hot flushes, as their diet is rich in soy. Phytoestrogens

have been found to reduce vasomotor symptoms such as hot flash in most of the epidemiological studies. One

study found a 45% decrease in menopausal flushes on women using 40-60 mg of soy products per day.

Phytoestrogens also have other benefits, like improved vascular compliance by 26% is noted, they cause a

favourable alteration in insulin resistance, improves glycaemic control and serum lipoproteins are altered

favourably. They also have lowered the incidence of osteoarthritis and prevent cardiac diseases in predisposed

women.20

A study was conducted to evaluate the effect of soy-derived isoflavones over hot flushes, menopausal

symptoms and mood in climacteric women. Fifty symptomatic climacteric women aged 40 to 59 with increased

BMI (≥25) were recruited to receive oral 100 mg/day of soy derived isoflavones for 6weeks. Hot flushes

(frequency/intensity), menopausal symptoms (Menopause Rating Scale [MRS]) and mood (Hamilton Depressive

Rating Scale [HDRS]) were evaluated at baseline and at 90 days. After 6weeks of soy isoflavone

supplementation, hot flushes significantly decreased in percentage, number and severity (p < 0.001). Menopausal

rating scale scores reflecting the general menopausal symptoms significantly decreased compared to baseline.

Regarding mood, after three months total Hamilton Depressive Rating Scale [HDRS]) scores and the rate of

women presenting depressed mood significantly decreased (p < 0.05).The results showed that, among high risk

climacteric population, soy derived isoflavone treatment improved mood as well as vasomotor and general

menopausal symptoms.21

The researcher had observed perimenopausal women experiences hot flash. Hence the researcher felt that,

there is an effect of soya bean consumption among perimenopausal women to reduce vasomotor symptoms such

as hot flash. Considering all the above factors, there is a need of soya bean consumption among perimenopausal

women.

6.2 REVIEW OF LITERATURE:

A study was conducted among postmenopausal Spanish women to analyze the effects of nutritional

intervention with a milk product enriched with soy isoflavones on quality of life and bone metabolism. Ninety-

nine postmenopausal women were selected randomly. Group S women (n=48) were randomized to consume

milk product enriched with soy isoflavone (50 mg/day) while group C (n=51) consumed product control for 12

months. Parameters of quality of life (Cervantes scale), markers of bone metabolism and bone mass estimated by

ultrasound of the calcaneus (QUS) were evaluated. Overall, there was an improvement in the domains

menopause (P=.015) and vasomotor symptoms (hot flash), (P<.001). In the assessment of QUS, there was an

increase in estimated bone mineral density in group S (P=.040), whereas in group C there were no significant

differences. The study concluded as daily consumption of these milk products increases levels of 25-OH-vitamin

D and decreases the vasomotor symptoms and bone metabolism markers.22

A study was conducted to find out the soy germ isoflavones to improve menopausal symptoms among

early postmenopausal Chinese women. Ninety early postmenopausal women aged 45 to 60 years, were randomly

assigned to three treatment groups (30 each) receiving daily doses of 0 (placebo), 84, and 126 mg of soy germ

isoflavones. Both the frequency of hot flushes and the Kupperman index score decreased in all three treatment

groups during the intervention period, but the percentage decreases in both were significantly greater in the two

isoflavone groups than in the placebo group. The results of the study revealed that a daily supplement of 84 or

126 mg soy germ isoflavones may decrease menopausal symptoms. 23

A survey was done to review current research on the effects of soy consumption on menopausal

symptoms. The methods used were meta- analysis and individual clinical trials. The survey reported that

isoflavone supplementation was associated with a 34% reduction in hot flashes, with increased efficacy as the

baseline number of flashes .This study concluded that consumption of 30 mg/day of soy isoflavones (or at least

15 mg genistein) reduces hot flashes by up to 50 %. The greatest benefit may be realized when the isoflavone-

rich food or supplement taken in divided doses by subjects who experience at least four, hot flashes/day.24

A study was conducted to investigate the efficacy of soy isoflavone on climacteric symptoms in

postmenopausal women. In this study, a total of 80 women with mean age 55.1 years, who reported 5 or more

hot flush episodes per day, were randomized to receive either 250 mg of standardized soy extract (Glycine max

AT) a total of 100mg/day of isoflavone. For 10-months, climacteric symptoms were evaluated using a score card

and the menopausal Kupperman index. After 10 months, there was a significant reduction in frequency of hot

flushes among isoflavone users when compared to those on placebo (p<0.001).Soy isoflavone was significantly

superior to placebo, in reducing hot flush severity (69.9%, (p<0.001). The study concluded that the soy

isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance, providing a safe and

effective alternative therapeutic for postmenopausal women.25

A study was conducted to evaluate effectiveness of isoflavones (Soyfem) administration among

postmenopausal women on reduction of moderate and medium-severe climacteric syndrome.555 postmenopausal

women were recruited for the study. Out of this group, 169 women completed the study (4-month observation

period). 1 or 2 tablets of Soyfem were administered twice a day. A regular decrease of Kupperman index value

and improvement of life quality were observed in the group of 169 postmenopausal women. The study noted that

a marked decrease in the intensity and number of hot flushes, diaphoresis (p < 0.05), diminished sleep

disturbances (p < 0.05), decreased headache, dizziness, and arthrosis pain. These findings supported that

administration of Soyfem in the dosage 52 to 104 mg/24 hours (2 times daily 1 or 2 tablets) is a safe and

effective therapy in the postmenopausal women with moderate and medium-severe climacteric syndrome

evaluated according to the Kupperman index.26

A study was conducted to evaluate the effect of soy isoflavones on improving peri-menopausal symptoms

and the secretion of estrogen. Fifty women accompany with peri-menopausal symptoms were single-blindly

randomized into two groups, the experimental group with a daily 120 mg/d of soy isoflavones for eight weeks

and the control group with placebos. The symptoms, such as the frequency of hot flash and sweating, insomnia

and Kupperman scores were observed. Hot flashes, Kupperman scores and other index were significantly

decreased (P < 0.01). The study came to the resulted that the menopausal symptoms and the secretion of estrogen

were improved in peri-menopausal women on a daily dosage of 120 mg of soy isoflavones.27

A study was conducted to assess the efficacy soy extract phytoestrogens with high dose of isoflavones for

menopausal symptoms among 180 women aged 40-65 years with a minimum of five moderate-to-

severe hot flushes per day and absence of menstruation for at least 6 months. Women received one tablet a day of

80 mg isoflavones (corresponding to 60 mg of genistein) for a period of 2week.The mean daily number of

moderate-to-severe hot flushes decreased, assessed by using kupperman index. The study revealed that daily

practice conditions, high doses of isoflavones, particularly genistein, can be used for the management

of hot flushes in postmenopausal women not treated with hormone replacement therapy.28

A scientific study was conducted to investigate the influence of soya isoflavones on menopausal

symptoms among postmenopausal women. One hundred and four postmenopausal women examined the

consumption of 60 grams of isolated soy protein with 60 grams of the common milk protein (casein) per day for

8 weeks. Women recorded the severity of hot flash daily in menopause dairy. After fourth week of treatment,

identified as the soy bean, which can reduce the frequency and intensity of hot flushes by 45% among

postmenopausal women, which was significantly different from the milk protein group. The study finding

revealed that phytoestrogens for their role in diminishing menopausal symptoms related to estrogen deficiency.29

A community based prospective study was conducted on Soy product intake and hot flashes in Japanese

women by Department of Public Health. A sample of 1106 women, the age between 35-54 years were selected

randomly. The women were received soya isoflavones during the 6 years of the study period, 101 women had

moderate or severe hot flashes according to the Kupperman test of menopausal distress. After data were

controlled for age, total energy intake, and menopausal status, hot flashes were significantly inversely associated

with consumption of soy products (p< 0.002). These data suggest that consumption of soy products has a

protective effect against hot flashes.30

6.3. OBJECTIVES OF THE STUDY:

1. To assess the pre-test level of hot flash among perimenopausal women in experimental and

control group.

2. To administer soya milk to the perimenopausal women among the experimental group.

3. To assess the effectiveness of soya milk consumption on reduction of hot flash among

experimental group.

4. To compare the level of reduction of hot flash among the experimental and control group.

5. To find out the association between pre-test level of hot flash and selected demographic variables

like age, religion, educational qualification, history of illness, dietary habits among experimental

and control group.

6.4. OPERATIONAL DEFINITIONS:

Assess: - It refers to measuring the level of hot flash among perimenopausal women.

Effectiveness: - It refers to the level of reduction of hot flash after the oral consumption of soya milk

among perimenopausal women as measured by using modified menopausal rating scale.

Soya milk: - It refers to the solution which is prepared with 60gm of soya bean soaked for 12-14hours,

grinding, mixed and boiled with 200 ml of milk and administered twice a day per week.

Hot Flash: - It is a momentary sensation of heat that may be accompanied by a red, flushed face and

sweating. The intense feeling of heat radiates to the face, neck, arms, sometimes whole body. The

sensation of heat lasts between two to four minutes, is often associated with profuse perspiration,

irritability, dizziness, headache, nausea and occasionally palpitations and is often followed by chills

and shivering.

Perimenopausal women: - It refers to those women aged above 40 years and who have not attained

menopause.

6.5. HYPOTHESES OF THE STUDY:

H1: There is a significant difference between the level of hot flash before and after soya milk

consumption in experimental group.

H2: There is a significant difference between the post test level of hot flash among experimental and

control group.

H3: There is a significant association between the pre-test level of hot flash and selected demographic

variables among experimental and control group.

6.6. ASSUMPTIONS:

Perimenopausal women aged above 40 years and who have not attained menopause may experience

hot flash.

Soya milk consumption may reduce hot flash among perimenopausal women.

Reduction of hot flash may improve the quality of life of perimenopausal women.

6.7. DELIMITATIONS:

The study is delimited to only perimenopausal women aged above 40 years and who have not attained

menopause with hot flash in selected urban areas at Mysore

6.8. PILOT STUDY:

The study will be conducted with 20 samples. The purpose to conduct the pilot study is to find out the

feasibility for conducting the study and design on plan for statistical analysis.

6.9. VARIABLES:

Independent variables: Oral administration of soya milk.

Dependent variables: Level of hot flash.

Demographic variables: age, religion, educational qualification, history of illness, dietary habits.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

The data will be collected from perimenopausal women aged above 40 years and who have not attained

menopause with hot flash in selected urban areas at Mysore.

7.1.1 RESEARCH DESIGN:

Quasi-experimental Design.

7.1.2 RESEARCH APPROACH:

Evaluative research approach.

7.1.3. SETTING OF THE STUDY:

The study will be conducted in selected urban areas at Mysore.

7.1.4 POPULATION:

The population selected for the study is perimenopausal women aged above 40 years and who have not

attained menopause with hot flash in selected urban areas at Mysore.

7.2 METHOD OF DATA COLLECTION:

Prior to the data collection formal permission will be obtained from concerned authority of urban areas.

The perimenopausal women aged above 40 years and who have not attained menopause with hot flash, will be

selected by inclusion criteria. Informed consent will be obtained from the perimenopausal women.

LEVEL 1: Assessment of pre-test level of hot flash by using modified menopausal rating scale among

experimental and control group.

LEVEL 2: Administration of soya milk among experimental group.

LEVEL3: Assess the effectiveness of soya milk consumption on reduction of hot flash among

experimental group.

LEVEL 4: Compare the effectiveness of soya milk consumption among experimental and control group.

7.2.1 SAMPLING TECHNIQUE:

Non probability purposive sampling technique

7.2.2 SAMPLE SIZE:

The sample size consists of 60 perimenopausal women aged above 40 years and who have not attained

menopause with hot flush in a selected urban areas at Mysore. 30 samples will be assigned in the experimental

group and 30 in control group.

SAMPLING CRITERIA:

7.2.3 INCLUSION CRITERIA:

Women aged above 40 years with hot flash and who have not attained menopause.

Women who are available at the time of study. .

Women who can understand Kannada.

7.2.4 EXCLUSION CRITERIA:

Women who are on HRT.

Women undergone total hysterectomy.

7.2.5 TOOLS FOR DATA COLLECTION:

Section A: Demographic proforma.

Section B: Modified menopausal rating scale.

7.2.6 PLAN FOR DATA ANALYSIS METHOD:

The data will be analyzed by using descriptive and inferential statistics.

Descriptive Statistics: Frequency, Percentage Distribution, Mean, Standard deviation and coefficient of

variation will be used.

Inferential Statistics:

Paired “t” test will be used to analyze pre- test and post- test level of hot flash in experimental and control

group.

Independent “t” test will be used to compare the level of hot flash among experimental and control group.

Chi squire test will be used to find the association between pre-test level of hot flash and selected

demographic variables among experimental and control group.

7.3. DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE

CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

Yes, soya milk will be administered orally to perimenopausal women aged above 40 years and who have

not attained menopause with hot flash.

7.4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF

THE ABOVE?

YES, ethical committee’s clearance has been obtained

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65-5.

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Dec 22 ]; Available from:

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12. Treloar SA, Pandeya. Predictive factors of age at menopause in Australia. Helmboil 1998; 70: 103-4.

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URL: http://www.webmd.com/menopause/guide/hot-flashes.

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today 2005; 10: 115-2.

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9. Signature of the Candidate :

10. Remarks of the Guide :

11. NAME AND DESIGNATION OF :

11.1 Guide :

11.2 Signature :

11.3 Co-Guide (If Any) :

11.4 Signature :

11.5 Head of the Department :

11.6 Signature :

12.12.1 Remarks of the Principal :

12.2 Signature :