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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate and address Mrs R.BHARATHI PRIYA (in block letters) SRI LAKSHMI COLLEGE OF NURSING, 127/1, SRI GANDADAKAVAL, MAGADI MAIN ROAD, VISHWANEEDAM POST, SUNKADAKATTE, BANGALORE-91. 2. SRI LAKSHMI COLLEGE OF NURSING, Name of the Institution 127/1, SRI GANDADAKAVAL, MAGADI MAIN ROAD, VISHWANEEDAM POST, SUNKADAKATTE, BANGALORE-91. 3. Course of study and subject M. Sc. NURSING OBSTETRIC AND GYNAECOLOGICAL NURSING 4. Date of admission to the course 5. Title of the study 01-06-2012 “A STUDY TO ASSESS THE EFFECTIVENESS OF INFORMATION BOOKLET ON KNOWLEDGE REGARDING POLYCYSTIC OVARIAN SYNDROME (PCOS) AMONG THE FEMALE STUDENTS IN SELECTED DEGREE COLLEGES AT BANGALORE KARNATAKA” . 1 6. BRIEF RESUME OF THE INTENDED WORK 6.1 Introduction Polycystic ovary syndrome - A metabolic malady, the mother of all lifestyle disorders in women - Can Indian health budget tackle it in future? The diverse and complex female endocrine disorder polycystic ovary syndrome (PCOS), which affects 1 in 15 women worldwide, is a major economic health burden that is likely to expand together with obesity, says Dr Theresa Hickey and Prof Robert Norman, says in edition of University of Adelaide, Australia. 1 The name polycystic ovary syndrome sounds worrying, but it doesn’t need to be. It is a very common condition affecting as many as 25% of “normal” women in some series. So at one end of the scale there are people with no obvious abnormality, and at the other extreme, people with excessive facial or body hair, infrequent periods and in fertility. 2 Polycystic ovarian syndrome (PCOS) is the 4th gynaecological problem of hospital admission. About 15 – 20 % of women in reproductive age group are affected by PCOS. A study conducted to understand the magnitude of Polycystic ovarian syndrome(PCOS) with sample size of 257 volunteers who were examined with ultrasonography showed that 22% were found to have polycystic ovaries. 3 The World Health Organization criteria for classification of an ovulation include the determination of oligomenorrhea (menstrual cycle >35 days) or amenorrhea (menstrual cycle > 6 months) in combination with concentration of prolactin, follicle stimulating hormone (FSH) and estradiol. Almost 80% of an ovulation patients have normal serum FSH and estradiol levels and demonstrate very heterogeneous symptoms ranging from an ovulation, obesity, biochemical or clinical hyperandrogenism and insulin resistance. PCOS is the most common cause of an ovulation in women with normal serum FSH and estradiol levels. Despite the heterogeneity in symptoms associated with PCOS, the essential feature is arrested follicular development at the stage when selection of the dominant follicle should normally occur. In a normal menstrual cycle, one egg is released from a dominant follicle – essentially a 2 cyst that bursts to release the egg. After ovulation the follicle remnant is transformed into a progesterone-producing corpus luteum, which shrinks and disappears after approximately 12– 14 days. In PCOS, there is a so-called “follicular arrest”, i.e., several follicles develop to a size of 5–7 mm, but not further. No single follicle reaches the preovulatory size (16 mm or more). The small ovarian follicles are believed to be the result of disturbed ovarian function with failed ovulation, reflected by the infrequent or absent menstruation that is typical of the condition. 4 Polycystic Ovarian Syndrome (PCOS) is the most commonly reported endocrine disease and the most common cause of infertility among women of childbearing age. Additionally, Norman, Dewally, Legro and Hickey report that PCOS is the “most frequent cause of hyperandrogenism and oligo-an ovulation, both of which have substantial psychological, social, and economic consequences (2007, 685). Originally reported by Stein and Leventhal in 1935, it is estimated that between five and ten percent of women suffer from PCOS. While the name of the syndrome is indicative of the presence of ovarian cysts, not all women with PCOS exhibit this particular symptom. In fact, women with PCOS may have two or more of a constellation of symptoms which may include amenorrhea (the absence of a regular menstrual cycle), infertility, hirsutism (the abnormal growth of hair in places such as the face, neck, abdomen and chest), acne, weight gain, insulin resistance/type 2 diabetes, high cholesterol, high blood pressure, thinning hair or male pattern baldness, acanthosis nigricans (areas of darkened skin discoloration generally found on the neck, breasts, arms or thighs), skin tags, pelvic pain, anxiety and/or depression generally related towards one’s appearance or the inability to conceive, and sleep apnea. 5 6.2 Need for study PCOS is the most common female endocrine disorder. Monika Woosley, RD, a leading nutrition expert onPCOS and eating disorders has termed PCOS “the perfect endocrine storm” Polycystic ovary syndrome (PCOS) has recently been shown to affect a striking 12%– 21% of Australian reproductive-age women, being more common among those who are overweight or of Indigenous background. PCOS can be a frustrating experience for women, a complex syndrome for clinicians and a scientific challenge for researchers, and is a major public health concern. Although reproductive features are prominent, PCOS has potential for major metabolic consequences, including obesity and related type 2 diabetes mellitus (DM2) as well as cardiovascular disease (CVD), all of which are currently national health priority 3 areas. It also has significant mental health and psychological impact, impairing quality of life. Because increased obesity exacerbates incidence, prevalence and severity of PCOS, and weight loss improves reproductive, metabolic and psychological features, lifestyle change should be first-line therapy for PCOS. It is estimated that 70% of Australian women with PCOS remain undiagnosed; clinical practice is inconsistent; psychological issues are underrecognised; and there is little focus on lifestyle and prevention, with most services targeting infertility and costly assisted reproductive technology. Given the prevalence, disease burden, health costs and clear gaps in care, PCOS is highlighted in national policy and has been prioritised by government. 6 PCOS affects 7-10% of women of childbearing age (15 to 45 years).In women of Indian subcontinent, prevalence rates as high as 50% have also been detected. PCOS was responsible for 18% of infertility and 40% of hirsutism cases in a study conducted at Srinagar. PCOS seems to run in families, and it is likely that it is a genetic disorder. Sisters of PCOS patients have about a 50% chance of also having PCOS. Metabolic syndrome was diagnosed in 46% ladies with PCOS in a study at Kolkotta recently. 7 Prevalence Rate for Polycystic ovary syndrome is approximately 1 in 40 or 2.50% or 6.8 million people in USA.8 Division of yoga and life sciences prospectively studied 460 girls aged 15 to 18 years from a residential college in Andhra Pradesh, South India, who underwent clinical examination. Out of which 72 girls with oligomenorrhea and/or hirsutism were invited for biochemical, hormonal, and ultrasonographic evaluation for diagnosis of PCOS by Rotterdam criteria. PCOS was defined as the presence of any two of the three features: (1) Oligo/amenorrhea: absence of menstruation for 45 days or more and/or ≤8 menses per year. (2) Clinical hyperandrogenism: Modified Ferriman and Gallway (mFG) score of 6 or higher. (3) Polycystic ovaries: presence of >10 cysts, 2-8 mm in diameter, usually combined with increased ovarian volume of >10 cm(3), and an echo-dense stroma in pelvic ultrasound scan.Out of 460 girls, one (0.22%) had oligo/amenorrhea with clinical hyperandrogenism, 29 (6.30%) had oligomenorrhewith polycystic ovaries, one (0.22%) had polycystic ovaries with clinical hyperandrogenism and 11 (2.39%) had oligomenorrhea with polycystic ovaries in the presence of clinical hyperandrogenism. Thus 42 (9.13%) girls satisfied Rotterdam's criteria for PCOS, which increased to 50.46 (10.97%) when inputed data were included. The study concluded that the prevalence of PCOS in Indian adolescents is 9.13%.This draws attention 4 to the issue of early diagnosis in adolescent girls. 9 Another population study reported that ultrasound scan showed that appearance of polycystic ovaries were present in 20% of women with normal menstrual cycles, in 26–32% with amenorrhoea, in 87–90% with oligomenorrhoea and in 90–95 % with hirsutism. One more study reported 50% women with recurrent miscarriage had the ultrasound picture of polycystic ovary. 10 According to women’s health organization Epigee, oligomenorrhea, or irregular periods, affect about 30% of women in their reproductive years. While amenorrhea, or the absence of menstruation (not caused by pregnancy), will happen to almost every woman at one point in her life. According to a 2012 study conducted by the Child Development Center at Medical College in Kerala, India ,PCOS is a leading cause of menstrual irregularity. Using a sample population of girls between 15 and 17 years of age who had reported menstrual irregularity and had not previously been examined for PCOS, researchers found that nearly 60% of all subjects did indeed have PCOS. 11 The potential health consequences of polycystic ovary syndrome are a lifelong issue. There is little doubt that the prevalence of impaired glucose tolerance and diabetesmellitus is increased substantially in women with polycystic ovary syndrome, although the magnitude of the increase depends on the prevalence of obesity in the population, and racial influences are evident. The evidence for increased risk of cardiovascular disease in women with polycystic ovary syndrome is less clear, although cardiovascular risk factors are substantially increased, including hyperlipidaemia, hyperandrogenaemia, hypertension, markers of prothrombotic state and markers of inflammation. Altered vascular endothelial function in young women with polycystic ovary syndrome is well documented, and increased death rates from cardiovascular disease have been shown in Polycystic Ovarian Syndrome women with menstrual irregularity (possibly with polycystic ovary syndrome) in the Nurses’ Health Study. Such evidence makes it clear that PCOS is a complex condition, requiring careful and attentive treatment over the course of a woman’s life. The increased risk across multiple body systems has the potential to put women in a rather precarious position .The vast amount of information and research on PCOS has been published by those in the medical field, especially those in the area of endocrinology. This 5 particular fact suggests the need to consider the production of knowledge. 5 Department of Obstetrics, Gynaecology and Reproductive Sciences, College of Medicine, University of Saskatchewan says polycystic ovary syndrome (PCOS) is a complex endocrine disorder that affects 6% to 10% of reproductive aged women. It is a poorly understood and often undiagnosed condition that has implications for the health of affected women. They assessed changes in knowledge, feelings, and daily health practices related to PCOS in clinical research study participants. Sixty-eight women who had received counselling and education about PCOS while participating in a clinical research study were invited to complete an online survey that assessed levels of concern, knowledge, healthy dieting, active living, and health care satisfaction before and after the study. Women with PCOS felt that they had more knowledge and motivation to implement preventive health strategies after participating in a clinical research study. Education about how PCOS affects their immediate and long-term health enabled women with PCOS to feel physical and psychological benefits and to engage more with their health care providers. 12 A prospective, non interventional case control study was conducted with 60 primary infertility patients, attending the gynecological department, S.S. Institute of Medical Sciences and Research Centre, Davangere, Karnataka. Aim is to establish the relation between PCOS and metabolic syndrome. An incidence of 38% of metabolic syndrome was noted in the PCOS cases studied. Women with PCOS were strongly associated with metabolic syndrome when compared with the controls. Obesity, high triglycerides and low high density lipoprotein levels are closely linked to insulin resistance and they are independent predictors of myocardial infarction and cardiovascular disease. Results strongly indicate the need for comprehensive screening and education program for women of all ages with PCOS. Modification of lifestyle factors such as diet and exercise along with insulin sensitizers and lipid lowering agents can prevent long term health risks. 13 Research consistently demonstrates that the first line of treatment for this condition is weight loss. Weight loss and dietary changes appear to affect all parameters of hormonal fluctuation. Because of potential side effects of many medications, weight reduction of obese patients should be the primary goal of treatment. The addition of antiandrogenic and insulin regulating agents should be added only to enhance the effects of weight loss. Experimental evidence has indicated that the typical western diet, which is high in fat and refined carbohydrate and low in fiber, induces insulin resistance and precedes obesity. Epidemiological evidence indicates that a diet rich in fruits, vegetables, and high fiber 6 complex carbohydrates is associated with a lower risk of chronic disease. Studies of obese women with menstrual abnormalities have demonstrated that cycles can potentially normalize and fertility be re-established following weight loss. Traditionally, sex steroids and thyroid hormones have been considered to be the major regulators of SHBG concentration, but dietary factors may be a more important consideration. Studies have been designed to explore caloric content and the role of dietary fat in the regulation of energy intake and weight loss. A study was performed to evaluate caloric consumption in women who each consumed a sequence of three two-week diets of low, medium, and high fat content. Results showed that by altering the type of food consumed, specifically fat, even without restrictions on amounts, spontaneous weight loss could be achieved in both obese and non-obese individuals on a low fat diet. 14 India has witnessed about 30 per cent rise in polycystic ovary syndrome (PCOS) cases in the last couple of years. It is a cause for major concern since it is increasingly being diagnosed in women who are in their reproductive age. Lack of awareness and lifestyle changes are considered to be the major factor leading to this phenomenon. There is a need to increase awareness among women so as to avoid major cases of fertility problem in future, according to Dr Rajeev Punjabi, gynecologist and obstetrician, Tulip Women’s HealthCare Centre, Mumbai. Dr Punjabi informs that women with PCOS have to maintain their lifestyle and control their diet for keeping PCOS under control. Women with PCOS should try to opt for low glycemic index foods, as they will cause a slower rise in blood sugar. Avoid those carbohydrates that trigger more hunger or cravings. The study stresses, “Women should be educated on the ill effects of this disorder since it can lead to a lot of problems. It’s a problem that needs urgent attention, since the incidence rate is increasing at a higher rate. Education, awareness, and self-control is the only way to control it from rising further and affecting more women15.” The above study suggest that the majority of the women are lacking knowledge on polycystic ovary syndrome. PCOS is most commonly reported endocrine disorder which has life long potential health consequences. Life style modification and diet can prevent polycystic ovary syndrome and risk factors. Hence the researcher is interested in assessing the effectiveness of the information booklet on knowledge regarding polycystic ovary syndrome among the female students in selected degree colleges Bangalore at Karnataka which will help the 7 female students to increase knowledge regarding polycystic ovary syndrome. 6.3 Review of literature Literature review is a standard requisition of scientific research. It means reading and writing the pertinent information of the attempt in research topic to understand better about the proposed topic. It also supports and explaines why the proposed topic is taken for research, and avoid unnecessary duplication explore the feasibility and illuminate the way of new researcher. The Review of Literature is organized as follows: Section A:- Literature related to incidence and prevalence of Polycystic ovarian syndrom (PCOS). Section B:- Literature related to etiology, clinical features, diagnosis, Management and Complication of Polycystic ovarian syndrome(PCOS). Section C:- Literature related to Prevention of Polycystic ovarian syndrome(PCOS) Section D:- Literature related to Knowledge of college girls on Polycystic ovarian syndrome(PCOS) Section E:-Literature related to effectiveness of information booklet Section A:- Literature related to incidence and Prevalence of polycystic ovarian syndrome(PCOS 5-10% women of childbearing age (20-40); 30% of women have some PCOS symptoms (NWHIC). 16 The incidence of PCOS varies according to the diagnostic criteria. Polycystic ovaries on ultrasound are noted in up to 25%-30% of reproductive aged women. Thus the vast majority of women with polycystic ovaries do not have the syndrome. Women with unexplained hyperandrogenic chronic an ovulation (i.e. NIH criteria) make up approximately 7% of reproductive age women10 8 The prevalence is estimated to be 4-8% in studies performed in Greece, and Spain.The prevalence of PCOS is increasing the world over and is showing a galloping increase in parallel with the rising prevalence of type 2 diabetes mellitus (T2DM). Use of different diagnostic criteria may partly account for it, as has recently been shown (18%) in the first community-based prevalence study based on current Rotterdam diagnostic criteria. PCOS has also been noted to affect 28% of unselected obese and 5% of lean women. In 2006,based on US data and traditionally lower prevalence estimates, the anticipated economic burden of PCOS in Australia was AU$400 million (menstrual dysfunction 31%, infertility 12% and PCOS-associated diabetes 40% of total costs), representing a major health and economic burden. 17 Section B:- Literature related to etiology, clinical features, diagnosis, Management and Complication of of polycystic ovarian syndrome(PCOS Odunsi and Kidd have put together the main theories that have been proposed in previous studies regarding etiology of PCOS. 1. The luteinizing hormone-theca interstitial cell (LHTIC) theory suggests that the pathophysiologic mechanisms leading to abnormally elevated levels of LH underlie the phenomenon of PCOS. The theory suggests that high levels of circulating LH cause an increase in the growth of TIC in developing follicles, which leads to androgen overproduction and follicular atresia. 2. The follicle stimulating hormone-granulosa cell (FSH-GC) theory suggests that the reduced FSH leads to subnormal induction of cytochrome P450 aromatase in the granulosa cells, leading to elevated androgen levels. This may be due to insufficient bioactive FSH in the follicular microenvironment to induce P450 aromatase gene expression, dysfunctional FSH receptor signal transduction mechanism, or the presence of inhibitors (such as epidermal growth factor and insulin-like growth factor (IGF)-binding protein that prevent the normal expression of P450 aromatase activity. 3. The third theory relates to the growth factor- autocrine-paracrine system. In PCOS, there is evidence of an altered IGF/insulin system, and these act as mediators of biologic responses of the selectogenic and atretogenic follicular hormones. 18 In a study published in 1998 in the journal Fertility and Sterility, Ricardo Azziz, a professor of obstetrics and gynaecology at the University of Alabama at Birmingham, looked at 13women with too much body hair who thought they were having regular periods. By 9 measuring their progesterone levels, he found that 40 percent of them actually ovulating irregularly. That suggests PCOS. A Harvard study found that 80 percent of women with fewer than six periods a year had abnormally high levels of male hormones. They, too, may be PCOS women. There is often no simple proof that a woman has polycystic ovarian syndrome (PCOS); diagnosis is based primarily on a woman's medical history and tests for insulin resistance. But the presence of several of the symptoms – infertility, hirsutism, menstrual irregularities and insulin resistance – is strong evidence. PCOS can be a challenge to diagnose because the disorder presents with a wide range of signs and symptoms that can easily be missed (Azziz,2004). Given the heterogeneity of the disorder, this condition is often under-diagnosed. Widely accepted criteria for diagnosis of PCOS in adolescent patients are based on standards that were established at the 1990 Consensus Conference of the National Institute on Child Health and Human Development (Kent & Legro, 2002). These criteria include chronic an ovulation and hyperandrogenism in the absence of other endocrine disorders. The presence of polycystic ovaries is not a criterion for diagnosis in adolescents as it is with young adults and middle age women as determined by the Rotterdam Criteria (2004). 2 Despite the high prevalence of PCOS, the diagnosis and differential diagnosis remains confusing. This is in part due to the lack of a specific diagnostic test for the disorder. The diagnosis of PCOS is based on hyperandrogenism or chronic anovulation in the absence of specific pituitary and/or adrenal disease .Oftentimes the clinical history and a few laboratory tests are enough to make the diagnosis and exclude other entities that may present in much the same way. A careful history and physical examination, looking for other signs of those disorders that may not be a part of PCOS, must be performed. Pelvic ultrasonography may be very helpful in the evaluation as well, but polycystic ovaries are not specific for PCOS with over 20% of “normal” women having this finding. The number of follicles and ovary volume are both important in the ultrasound evaluation19 It is estimated that 60% to 80% of women with PCOS demonstrate elevated circulating androgen levels. Serum levels of free testosterone, and not total testosterone, are more frequently elevated in women with PCOS. Serum free testosterone is therefore considered to be the most sensitive biochemical marker supporting a diagnosis of PCOS. Hirsutism is the most common clinical manifestation of hyperandrogenism in women. Approximately 60% to 70% of women with PCOS have hirsutism. Hirsutism is defined as excessive terminal hair 10 growth that takes on a male pattern distribution. One third of women with PCOS, particularly younger women, demonstrate acne. Androgens participate in the development of acne by stimulating sebum production, thereby providing optimal conditions for bacterial colonization with organisms. While the actual prevalence of alopecia in women with PCOS is relatively low compared with other androgenic symptoms (approximately 5%), an association with polycystic ovaries has been reported, and this observation merits an investigation of whether alopecia is actually increased in prevalence or severity in women with PCOS. Menstrual disturbances in PCOS generally present in the form of oligo-amenorrhea (fewer than eight episodes of menstrual bleeding per year or menses that occur at intervals greater than 35 days). The researchers believe a conservative diagnosis is more likely to motivate appropriate education, judicious treatment, and long-term follow-up of patients as the actual health risks of these distinct phenotypes are slowly revealed. 20 A descriptive study was conducted in Holy Family Hospital, Rawalpindi, Pakistan from Nov 2001 to Oct 2002 to review different clinical endocrine manifestation of polycystic ovarian syndrome in adolescent girls. Adolescent girls diagnosed with polycystic ovaries on ultrasound seen in the out patients department for menstrual problems were included in the study. Their body mass index, waist hip ratio, hirsutism scoring was done. Serum FSH and LH were estimated to see the ratio. A total of 52 unmarried girls between 15 to 25 years of age were included. Most of the girls were having oligomenorrhea (88%). While overweight girls were 34 (65%) and mild to moderate hirsutism was seen in 46 (88%). Serum FSH:LH ratio was normal in 25 (48%) and raised in 27 (52%). Earliest manifestation was hirsutism, and as body weight increased, there was linear increase in hirsutism and menstrual disturbances. The study concluded Polycystic Ovarian syndrome, a common problem of women of reproductive age group is affecting their life physically, mentally and socially. The clinical manifestations are variable with obesity playing the key role. 21 A study was designed to assess, with a randomized, double-blind, placebo-controlled protocol, the effects on menstrual abnormalities of a 6-month course of metformin in a group of 23 subjects with PCOS with normal glucose tolerance. Subsequently, 18 of these subjects and 14 additional women with PCOS were included in an open trial to evaluate the long-term effects of metformin on clinical features of the syndrome and to determine any baseline predictors of the treatment’s efficacy. In conclusion, in women with PCOS metformin treatment reduced hyperinsulinemia and hyperandrogenemia, independently of changes in body weight. In a large number of subjects these changes were associated with striking, 11 sustained improvements in menstrual abnormalities and resumption of ovulation. Higher plasma insulin, lower serum androstenedione, and less severe menstrual abnormalities are baseline predictors of clinical response to metformin. 22 Stress, pollution, and diet all affect the course of PCOS although it is not yet known exactly how they influence the disease. Under stress, the body responds by increasing hormone production, including production of cortisol and adrenaline, the “fight or flight” hormones. Cortisol can encourage weight gain, irregular periods, acne, excess body hair, high blood pressure, and diabetes – exacerbating PCOS symptoms. 23 In an observational study of adolescent women with PCOS, van Hooff et al found a significant decrease in the frequency of self-reported acne, dysmenorrhea, and menstrual irregularities in those engaging in more than eight hours of sporting activity per week. Although few studies have reported on the link between exercise and PCOS, clear associations have been made with regard to exercise and its effects on obesity and insulin resistance. A recent study in The Journal of the American Medical Association (JAMA) confirmed that fiber consumption could predict insulin levels, weight gain, and other cardiovascular risk factors more strongly than saturated fat consumption. Chromium is one of the most widely studied nutritional interventions in the treatment of glucose- and insulin-related irregularities. While research shows a clear link between chromium and glucose metabolism, evidence for its interaction in insulin resistant states is a bit more ambiguous. 24 A study was conducted with the aim to assess differences in anxiety and depression between women with and without (controls) polycystic ovary syndrome (PCOS). A systematic review and meta-analysis of published literature comparing women with PCOS to control groups on anxiety and depression. Electronic databases were searched up to 17 December 2010. The inverse variance method based, as appropriate, on a random- or fixedeffects model in Review Manager, Version 5 was used to analyse the data. Twelve comparative studies were included; all studies assessed depression and six also assessed anxiety . Analysis revealed higher depression and anxiety scores in the participants with, than without, PCOS. Studies controlling for BMI showed a smaller difference between women with PCOS and controls on anxiety and depression scores than studies not controlling for BMI. Women with PCOS on average tend to experience mildly elevated anxiety and depression, significantly more than women without PCOS. Women with PCOS with lower BMI tended to have slightly lower anxiety and depression scores, suggesting that having a 12 lower BMI reduces anxiety and depression. 25 PCOS patients are at higher risk for the metabolic syndrome, which is a group of cardiovascular risk factors that include dyslipidemia, type 2 diabetes mellitus, hypertension, and obesity. In a study of 254 women with PCOS, the prevalence of impaired glucose tolerance was 31% compared with 10.3% in controls, and the prevalence of type 2 diabetes was 7.5 % compared with 1.5% in controls26 Section C:- Literature related to Prevention of Polycystic ovarian syndrome(PCOS) The evidence is overwhelming that diets rich in fruits, vegetables, complex carbohydrates,and fiber lower chronic disease risk. High fiber diets, particularly diets high in soluble fiber, prevent dyslipidemia and lower blood pressure .Overall, findings are ambiguous regarding the supplemental use of flaxseed, glucomannan, guar gum, vitamin E, chromium, magnesium, and the botanical saw palmetto for PCOS . Exercise is proven to reduce insulin resistance and facilitate weight loss. Women with PCOS should participate in regular aerobic exercise and strength training to improve their physical and mental well-being27 A study was conducted to evaluate the influence of Dietary management and Physical exercise on ovarian function and metabolic parameters in overweight adolescent girl with Polycystic ovarian syndrome (PCOS). A sample of 57adolescent girls were supervised by dietician on randomized 4 month trial with three interventions and a long term follow up. The result shows that on average, body mass index was reduced 6% by the dietary management, 3% by the exercise and 5% by the combined interventions. The menstrual pattern significantly improved in 69% and ovulation confirmed in 34%. The study highlights that dietary management and exercise or combination of both are equally effective in improving reproductive function in obese adolescent girls with PCOS. 28 Section D:-Literature related to Knowlegde of adolescent girls on Polycystic ovarian syndrome(PCOS) As many as 1 out of every 15 assessed was found to be suffering with PCOD in Wellington college and their knowledge was very poor regarding the subject. College girls were afraid to talk about their disease to the parents 29 A study was conducted in Australia to describe young women perception and awareness of Polycystic ovarian syndrome (PCOS), among age group of 18-22years using a questionnaire. The study showed that participants lacked knowledge about the disease and 13 complicated quality of life(p=0.033). The young women only perceived the risk of obesity (p=0.0001), infertility (p=0.023), loss of femininity (p=0.035) and loss of sexuality (p=0.003). The study highlights that young women did not know the disease but only few risks associated with it knowing the disease and therefore health education regarding PCOS is helpful in knowing the disease and perceived risk outcomes through educational methods. 30 Section E:- Literature related to effectiveness of information booklet A study was conducted to assess the effectiveness of information booklet on knowledge of people residing in selected areas of Pune city regarding Disaster Preparedness. Evaluative approach and quasi experimental one group pre-test post-test research design was used. Sample for the current study was selected according to non-probability purposive sampling technique consists of men and women between 21 to 50 years residing in diverse areas of Pune city. Semi-structure questionnaire was used to assess the effectiveness of information booklet on knowledge about disaster preparedness of study samples. Descriptive and inferential statistics had been used for data analysis. Analysis of the data showed that majority 88.3% of people in pre -test were having moderately adequate knowledge (scores 11-20), 8.3% of people in pre-test were having inadequate knowledge (scores 0-10) and only 3.3% of people in pre-test were having adequate knowledge (scores 21-30), whereas in post-test majority 81.7% of the people had adequate knowledge (scores 21-30) and 18.3 % of people in post-test were having moderately adequate knowledge(scores 11-20), which indicates that the information booklet improved knowledge of people regarding disaster preparedness 31 The study supports that the information booklet is effective in improving knowledge. A study, attempted to assess the level of knowledge about palliative care among nurses working in the oncology department using a self administered structured questionnaire and also to assess the effectiveness of information booklet designed on various aspects of palliative care on their knowledge in Indo American Cancer Hospital, Hyderabad, AP, India. A structured self administered questionnaire was prepared and administered as a pre-test. An information booklet was developed pertaining to the general concepts of palliative care, care components (physical, social, emotional and spiritual) and role of the nurse in palliative care and it was given to the participants. As a post test, the same questionnaire was re-administered after four days to the same study subjects. Pre-test and post-test knowledge scores were compared and the findings were analyzed statistically. The information booklet was effective in enriching the knowledge of nurses on palliative 14 care. Enhancing the nurse’s knowledge about palliative care will promote their understanding of the needs of the advanced stage patients and will enable them to provide quality care. 32 This study supports that the information booklet is effective in improving the knowledge of the people. 6.4 Statement of the problem “A study to assess the effectiveness of the information booklet on knowledge regarding polycystic ovarian syndrome (PCOS) among female students of selected degree colleges at Bangalore , Karnataka 6.5 Objectives of the study Objectives of the study are to: 1. To assess the existing level of knowledge regarding polycystic ovarian syndrome among the female students of degree colleges by knowledge score in experimental group and comparison group. 2. To administer Information Booklet to only experimental group. 3. To evaluate the effectiveness of the information booklet regarding polycystic ovarian syndrome among the female students of degree colleges in experimental group by post test knowledge score. 4. To asses the post test knowledge level regarding polycystic ovarian syndrome among the comparison group. 5. To find out the difference between level of knowledge on PCOS among the female students of degree colleges by post test knowledge score in experimental group and comparison group. 6. To find out the association between demographic variables such as age, year of education, religion, family income, occupation of the father, occupation of the mother, type of family, life style, nutrition, place of residence and source of information with the pre test knowledge score among the female students of degree colleges. 6.6 Operational definitions ASSESS: It is the organised systematic continuous process of collecting data from pre test and 15 Post test knowledge regarding polycystic ovary syndrome score among the female students of degree colleges. Effectiveness: In this study, it refers effectiveness refers to the extent to which information booklet has achieved the desired effect to increase in the knowledge on PCOS among the female students of degree colleges as assessed by the post test. Information booklet: In this study it refers self-learning information prepared in English to improve the knowledge on poly cystic ovary syndrome which includes anatomy and physiology of uterus, definition, incidence and prevalence, etiology, pathophysiology, clinical manifestation, management ,complications and prevention of PCOS. Knowledge: In this study, it refers to the correct responses by the female students of degree colleges regarding polycystic ovarian syndrome as elicited through a self administered questionnaire. Polycystic ovarian syndrome: Polycystic ovary syndrome (PCOS) is one of the most common female endocrine disorders.The principal features are anovulation, resulting in irregular menstruation, amenorrhea, ovulation-related infertility, and polycystic ovaries; excessive amounts or effects of androgenic hormones, resulting in acne and hirsutism; and insulin resistance, often associated with obesity, Classic symptoms include excess facial and body hair, acne, obesity, irregular menstrual cycles, and infertility. Female students of seleted degree colleges female Students studying in the selected degree colleges other than professional colleges at Bangalore in Karnataka. HYPOTHESIS:6.7 H1. There will be statistically significant difference between pre-test and post-test knowledge scores among female students of degree colleges in experimental and comparison group regarding polycystic ovary syndrome (PCOS) at 0.01 and 0.05 level of significance. H2- There will be significant association between selected demographic variables with the level of knowledge of female students regarding polycystic ovary syndrome (PCOS) in experimental and comparison group at 0.01 and 0.05 levels of significance. 6.8 ASSUMPTIONS:- 6.8.1 The female students of degree colleges may not have adequate knowledge about polycystic ovary syndrome (PCOS). 6.8.2 The female students of degree colleges would willingly participate in the study and express 16 their knowledge on polycystic ovary syndrome (PCOS). 6.8.3 6.8.4 The female students of degree colleges will be curious to learn about polycystic ovary syndrome (PCOS). The information booklet will be effective to improve the knowledge of female students of degree colleges. 6.9 6.9.1 6.9.2 DELIMITATIONS:The study is delimited to the female students of degree colleges at Bangalore, Karnataka. Assessment of knowledge is based on the responses to the objective type test item used in self administered questionnaire. 7.0 MATERIALS AND METHODS:SOURCE OF DATA 7.1 The data will be collected from female students of selected degree colleges at Bangalore, Karnataka 7.2 METHOD OF COLLECTION OF DATA :- 7.2.1 RESERCH DESIGN Quasi experimental non equivalent control group design will be used (O1XO2) –Experimental group (O1XO2)-Comparison group 7.2.2 RESEARCH APPROACH Quantitative Evaluative survey approach will be used. 7.2.3 SETTING Study will be conducted in selected degree colleges at Bangalore, Karnataka. 7.2.4 VARIABLES UNDER STUDY INDEPENDENT VARIABLES Information Booklet on polycystic ovary syndrome (PCOS) . DEPENDENT VARIABLE 17 Knowledge of the female students of degree college on polycystic ovary syndrome (PCOS) . EXTRANEOUS VARIABLE Demographic variables such as age, year of education, religion, family income, occupation of the father, occupation of the mother, type of family, life style, nutrition, place of residence and source of information of female students of selected degree colleges. 7.2.5 POPULATION Target population: The target population of the study comprises of female students of degree colleges Accessible population: Female students of selected degree colleges at Bangalore, Karnataka. 7.2.6 SAMPLE The sample of the study consists of female students of selected degree colleges at Bangalore, Karnataka. 7.2.7 SAMPLE SIZE In this study sample consists of 120 female students of selected degree colleges at Bangalore, Karnataka.60 female students of one college for experimental group, 60 female students of other college for comparison group 7.2.8 SAMPLING TECHNIQUE: Non probability, purposive sampling technique will be used. 7.2.9 SAMPLING CRITERIA: INCLUSION CRITERIA 1. Female students studying in selected degree colleges. 2. Female students of age group 17-21years. 3. Female students who can communicate in English. 4. Female students available during period of study. EXCLUSION CRITERIA 18 1. Female students of age groups more than 21 years. 2. Female students who are not willing to participate in the study. 3. Female students who are not available at the time of study. 4. Female students studying in professional colleges. 5. Female students who are married. 7.2.8 TOOLS FOR DATA COLLECTION: The self administered questionnaire will be used to collect data. The tool for data collection consists of two sections. Section A: Self administered questionnaire seeks information on demographic variables such as age, year of education, religion, family income, occupation of the father, occupation of the mother, type of family, life style, nutrition, place of residence and source of information Section B: Structured questionnaire to assess the knowledge of PCOS among female students of selected degree colleges 7.2.9 DATA COLLECTION PROCEDURE: The data will be collected by using self administered questionnaire on Demographic variables such as Demographic variables such age, year of education, religion, family income, occupation of the father, occupation of the mother, type of family, life style, nutrition, place of residence and source of information and the knowledge of female students of selected degree colleges The pre-test knowledge level of the female students will be assessed by using self administered questionnaire following that the Information Booklet on poly cystic ovary syndrome will be given to the students. After a week post test is conducted by using the Self administered questionnaire to know the effectiveness of Information Booklet on poly cystic ovary syndrome . METHODS OF DATA ANALYSIS AND INTERPRETATION: 7.2.10 The obtained data will be analyzed through Descriptive AND inferential statistics. Descriptive statistics - Demographic variables are to be analyzed in terms of frequency and percentage. 19 - Assessing the knowledge regarding poly cystic ovary syndrome in female students of the selected degree colleges will be interpreted by descriptive statistics such as mean, median and standard deviation. Inferential statistic - Effectiveness of Information Booklet on PCOS among female students of the selected degree colleges will be analyzed by t-test. - Chi-square test will be used to determine the association between selected demographic variables and pre test knowledge level of PCOS in female students of the selected degree colleges 7.2.11 DURATION OF DATA COLLECTION: Four weeks 7.2.12 PROJECTED OUTCOME: There will be significant increase in the knowledge among female students of the selected degree colleges regarding poly cystic ovary syndrome. 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? Yes, Information Booklet on poly cystic ovary syndrome will be given to the study participants as a part of the research study. 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION Yes, ethical clearance will be obtained from the research committee of Srilakshmi College of Nursing, Bangalore. 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Available fromhttp://www.sinhgad.edu/SinhgadNursingCollege-eJournal/pdf/auther4.pdf 32. Anita David and Sonali Banerjee Effectiveness of “Palliative Care Information Booklet” in Enhancing Nurses’ Knowledge Indian J Palliat Care. 2010 Sep-Dec; 16(3): 164–167. doi: 10.4103/0973-1075.73647PMCID: PMC3012240. Available fromhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3012240 23 9. Signature of the candidate 10. Remarks of the guide 11. Name and designation of (in block letters) ASSISTANT PROFESSOR 11.1 Guide HOD O.B.G SRI LAKSHMI COLLEGE OF COLLEGE OF NURSING BANGALORE 11.2 Signature LECTURER 11.3 Co-guide SRI LAKSHMI NURSING BANGALORE 11.4 Signature ASSISTANT PROFESSOR 11.5 Head of the department HOD O.B.G SRI LAKSHMI NURSING BANGALORE 11.6 Signature 12. 12.1 Remarks of Chairman and principal 12.2 Signature 24 COLLEGE OF