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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION. 1. NAME OF THE CANDIDATE Mrs. SHASHIKALAVATHI AND ADDRESS GOUTHAM COLLEGE OF NURSING MANJUNATHA NAGAR, WEST OF CHORD ROAD RAJAJINAGAR, BANGALORE-10. 2. NAME OF THE INSTITUTION GOUTHAM COLLEGE OF NURSING MANJUNATHA NAGAR, WEST OF CHORD ROAD RAJAJINAGAR, BANGALORE-10. 3. COURSE OF STUDY AND I YEAR M.Sc. NURSING SUBJECT OBSTETRICS AND GYNAECOLOGICAL NURSING. 4. DATE OF ADMISSION TO 16.10.2007. COURSE 5. TITLE OF THE TOPIC A STUDY TO ASSESS THE EFFECTIVENESS OF SELF INSTRUCTIONAL MODULE ON POLYCYSTIC OVARY SYNDROME AMONG THE ADOLESCENT GIRLS IN A SELECTED COLLEGE OF BANGALORE. 1 6. BRIEF RESUME OF THE INTENEDED WORK 6.1 NEED FOR THE STUDY: Pcos (Polycystic Ovary syndrome) an endocrine disorder, which means normal hormone cycles are interrupted. The syndrome was originally reported by Stein and Leventhal in 1935 when they described a group of women with Amenorrhea, Infertility, Hirsuitism and enlarged poly cystic ovaries. Polycystic are two to five times larger than normal ovaries. Women are usually diagnosed when in their 20’s or 30’s. This can contribute to infertility. Possible complications are, Sterility, Obesity, Related conditions like high blood pressure and diabetes, Increased risk of Endometrial Cancer, Possible increased risk of Breast Cancer.1 Pcos is reported to be growing problem with Adolescent girls .It can be very difficult to diagnose pcos in teenage girls as they often experience irregular or absent menses and acne. The underlying cause of pcos may or may not be detectable in Adolescents during the onset of pcos symptoms. As a result researchers report that pcos is often missed in this age group. This causes great concern among clinicians due to the potentially serious complications associated with these conditions.2 Pcos occurs in 5% to 10% of women, making it one of the most common endocrine disorder.3 Pcos is a heterogeneous endocrine disorder that affects about 1 in15 women worldwide.4 The prevalence of pco in Indian sub continent Asian women was 52%.5Polycystic morphology seen in ultrasound is approximately 22% of women.6 Hirsutism is a common problem in India as elsewhere in the world. Idiopathic hirsutism 38.7%, pcos 37.3%.. In India nearly 40% of women are affected by pcos. But among them only 60% come to hospitals for treatment, when they recognize that they have got infertility21. 2 Pcos also known by the name Stein Leventhal syndrome is a variety of symptoms. The symptoms of pcos includes, irregular or no menstrual periods, Acne, obesity, excess hair growth, oily skin, dandruff., Infertility, skin discolorations, High cholesterol levels, Elevated blood pressure and Abnormal hair growth and distribution. Any of the above symptoms and signs may be absent in pcos, with the exception of irregular or no menstrual periods. All women with pcos will have irregular or no menstrual periods.8 A report released in the British journal of obstetrics and gynecology in 2000 indicated that up to 40% of women with pcos have either impaired glucose tolerance or type 2 diabetes by age 40. In addition, with pcos, high levels of insulin stimulate the ovaries to produce large amounts of testosterone (A male hormone), which can possibly prevent ovaries from releasing an egg each month thus causing infertility. High testosterone levels can also cause excessive hair growth male pattern boldness and acne. In patients with pcos insulin resistance encourages the storage of fat and the production of excessive amounts of testosterone.9 Pcos are readily identified by pelvic ultrasound because, they are larger than normal size (overage volume three times that in normal women).10 The diagnosis of pcos is based on ultrasound scan of the ovaries using a vaginal probe and a hormone profile including measurement of FSH /LH, testosterone and androstenedione .11 Lifestyle modification with increased physical activity and weight reduction remains first line of therapy.12 Treatment of Pcos includes weight loss of more than 5% of previous weight is important and will help in restoring the hormonal milieu to some extent. Cigarette smoking raises DHEA (Dehydroepiandrostenedione, Which produces androgens) it should be avoided. Estrogen suppresses androgen and adrenal production. It is in oral contraceptives. Dexomethosone 0.5Mg or Prednisolone 5Mg at bed time also reduces androgen 3 production. Hirsutism is treated with cyproteron acetate (Prevents recurrence of hirsutism) Infertility is treated With clomiphene 80% ovulate and 40% conceive. Surgery is reserved for those in who medical therapy fails hyper stimulation occurs. Surgery comprises laparoscopic multiple punctures of the cysts with electrocautery or laser.13 The symptoms of pcos are major source psychological morbidity and can negatively affect quality of life of adolescents. One of the symptoms acne is the area least reported upon in terms of its impact upon health related quality of life.14 A few small studies have also suggested an increased risk of depression in women with pcos.15 As pcos is among the most common during adolescence, there is always a need to investigate all new relevant data. Early recognition and prompt treatment of Pcos in adolescents is important to prevent long term sequel. More research is necessary in order to find answers to many clinical and the theoretical aspects of the syndrome.16 The onset of pcos occurs during adolescence since it is known that incidence of pcos is more among adolescents. They are suffering from physical and psychological morbidity. There is an increasing number of adolescents are presenting with signs of pcos and also there is an increased risk of cardiovascular, metabolic and depressive disorders. Mainly they will face problems like disturbance in their body image because of certain pcos related problems. It causes a psychological disturbances and also if untreated it may lead to complication of pcos. The pcos is a source of psychological morbidity and also can negatively affect the quality life of adolescents. So, early recognition, prevention and treatment is important to prevent long term sequel and to develop a positive attitude and follow healthy life style. From the above studies the investigator found adolescent girls have lack of knowledge regarding pcos and 4 they are neglecting taking care of the disease. Hence, the researcher is interested to educate the adolescent girls regarding pcos by giving them self instructional module and assess the effectiveness of Self instructional module. 6.2 REVIEW OF LITERATURE: Review of literature for this study has been organized under the following headings. 6.2.1. Studies related to polycystic ovary syndrome. 6.2.2 Studies related to prevalence of polycystic ovary syndrome. 6.2.3 Studies related to etiology of polycystic ovary syndrome. 6.2.4 Studies related to diagnosis and treatment of polycystic ovary Syndrome. 6.2.5 Studies related to complications of polycystic ovary syndrome. 6.2.6 Studies related to quality of life of adolescents with polycystic ovary syndrome. 6.2.1. Studies related to polycystic ovary syndrome. A study conducted on Pcos is a heterogeneous endocrine disorder that affects about 1 in 15 women worldwide. The major endocrine disruption is excessive androgen secretion or activity, and a large proportion of women also have abnormal insulin activity. Many body systems are affected in Pcos, resulting in several health complications including menstrual malfunction, infertility, hirsutism, acne, obesity, and metabolic syndrome. Women with this disorder have an established increased risk of developing type 2 Diabetes and still debated increased risk of cardiovascular disease. The diagnostic traits Pcos hyperandrogenism, chronic and anovulation, and polycystic ovaries, after exclusion of other conditions that cause these same features.4 A study conducted on “pcos and adolescents” by US scientists that is pcos is the most common form of chronic anovulation associated with androgen excess perhaps occurring in 5% to 10% of reproductive age women. Infertility is 5 caused by failure of ovulation although hyper secretion of LH (leutinizing hormone) is also and important in this regard, obesity often associated with an increase in the ratio of waist to hip circumference is the 3rd classical feature. The classical profile is the hyper secretion of LH androgens with normal circulating FSH, prolactin and thyroxin concentration. In-fact spectrum of endocrine findings occurs, reflecting the phenotype heterogeneity of the Pcos. In a study of more than 1500 cases 44% had and elevated serum LH and 22% an elevated serum total testosterone concentration. Levels of LH were raised most commonly in the women complaining of infertility and of testosterone in those complaining of hirsutism.10 6.2.2 Studies related to prevalence of polycystic ovary syndrome. A study conducted on “Prevalence of pcos in Women of Reproductive Age”. 189 healthy women aged between 20-45 years were included in the study. The women were divided into 2 groups, those 35 years of age and younger and those 36 years age and older, on cycle days 1-6 trans vaginal ultrasound was performed and blood samples were collected. There was 14.2% prevalence of pcos in entire group (27/189). The prevalence was 21.6% in women 35years and younger and 7.8% in the women 36years and older. Significantly more irregular cycles were seen in women with pcos than in those with normal (44%v/s 19%). In healthy women, the prevalence of pcos varies with age. The binding are more common in women younger than 35 years.17 A study conducted on Prevalence of ultrasonography proved polycystic ovaries in North Indian women with type 2 diabetes mellitus. Polycystic ovary syndrome as well as type 2 diabetes mellitus is common medical conditions linked through insulin resistance. 105 reproductive age group women with diet and /or oral hypoglycemic treated T2DM were the subjects of the study. 60 nondiabetic women served as controls. Trans abdominal ultrasonographic assessment of the ovaries was used to diagnose pcos. Clinical, biochemical and hormonal parameters were also noted. Ultrasonographic prevalence of pco was higher in 6 women with diabetes than in non-diabetic subjects, whereas that of pcos was 37.1% in diabetic subjects and 25% in non-diabetic controls. Diabetic women with pco had diabetes of significantly longer duration than those without pco. Among both diabetic and non-diabetic women, those with pco had significantly higher plasma LH, LH/FSH ratio, and total testosterone and androstenedione levels. This study demonstrates a higher prevalence of pco in women with T2DM as compared to non-diabetic subjects 18. 6.2.3 Studies related to etiology of polycystic ovary syndrome. The cause of pcos is unknown, but studies suggest a strong genetic component that is affected by gestational environment, life style factors, or both.4 A study conducted on Epidemiologic and etiologic aspects of hirsutism in Kashmiri women in the Indian subcontinent. To assess the prevalence of hirsutism and study its etiology in the Kashmir Valley of the Indian subcontinent. 5000 women attending various hospitals for reasons unrelated to hirsutism and 150 consecutive women referred for hirsutism were in study. The etiology of hirsutism revealed idiopathic hirsutism in 38.7%, pcos in 37.3%, postmenopausal state in 9.2%, adrenal tumors in 2.1%, congenital adrenal hyperplasia in 1.4%, and drug-induced hirsutism in 0.7%. The cause remained undetermined in 10.6% of patients. Hirsutism is as common a problem in the Kashmir Valley (India) as elsewhere in the world. Idiopathic hirsutism (38.7%), pcos (37.3%), and postmenopausal state (9.2%) are common causes of hirsutism. Late-onset congenital adrenal hyperplasia is a relatively uncommon cause of hirsutism in the Kashmir Valley.7 6.2.4 Studies related to diagnosis and treatment of polycystic ovary Syndrome. A study conducted on “Diagnosis Management of Pcos-A Practical Guide”, Pcos is a syndrome, which can be defined as a group of recognizable patterns of symptoms or abnormalities that indicate a particular medical situation. The current definition of Pcos requires the presence of two of the following three 7 conditions: (i) Oligo and /or anovalation, (ii) Clinical and/or biochemical signs of hyper androgenism, and (iii) Polycystic ovaries-and the exclusion of other etiologies. An approach to a patient with possible Pcos should be directed towards making a diagnosis and screening for associated endocrine abnormalities. Therapeutic interventions are directed towards addressing the need of the patient at present and towards preventing long term complications of the syndrome. Body Mass Index (BMI), which is a primary mediator in the relationship between Pcos and HRQL in obese Pcos adolescents. Any intervention directed at reducing central obesity will not only improve quality of life but also correct hyperinsulinism and improve fertility and lipid and androgen profile19. A study conducted on “Current Approaches to the Diagnosis and Treatment of Polycystic Ovarian Syndrome in Youth”. Pcos often presents during late adolescence but in some cases certain features are evident even before menarche. The diagnosis is based on a typical physical exam and laboratory evidence of hyper androgenism, such as elevated free testosterone, androstenedione and dehydroepiandrosterone sulfate (DHEAS), decreased sex hormone-binding globulin (SHBG) and increased luteinizing hormone (LH). An ovarian ultrasound may detect the multiple cysts. Oral contraceptive therapy is used to reduce androgen and LH levels with resultant improvement in acne and hirsutism, and the induction of regular menses. Anti androgens are usually required for a substantial improvement in hirsutism score. Insulin sensitizers such as metformin are a new class of drugs utilized in treatment of pcos. Despite all the available medications, life-style changes are the mainstay of therapy as weight loss and exercise improve all parameters of Pcos without the potential side effects of medication.20 A study conducted on Benefits of Kayakalpa Yoga over pcos patients, The aim of the study is to evaluate the benefits Kayakalpa yoga in pcos patients. “Natural forces within us are the best healers of diseases.” Pituitary glands control the endocrine metabolism of our body. By giving treatment to pituitary 8 gland the pcos could be cured. Kayakalpa yoga is an intrinsic factor, done to regulate the endocrine metabolism of our body. Pcos is one of the endocrinal disorders; this yogasana is applicable to patients suffering from pcos. Obesity is one of the causative factors for pcos patients .Due to this yogasana our body will be reduced. So in the study, a new approach is analyzed to control the obesity factor in pcos patients. Kayakalpa yoga is a rejuvenating technique , which maintains the potency of our body and extends life span.21 6.2.7 Studies related to complications of polycystic ovary syndrome. A study conducted on increase risk of the depressive disorders in women with pcos, is associated with several metabolic complications. A few small studies have also suggested an increased risk of depression in women with Pcos. The goals of this study were to estimate the prevalence of depressive disorders in women with Pcos compared with controls and to evaluate the correlation between depression, hyperandrogenism, and other metabolic markers. Women with pcos. Women without pcos seen during the same time. Period for an annual exam were used as control subjects. Depressive disorders, Women with pcos were at an increased risk for depressive disorders compared with controls. The report was a significantly increased risk of depressive disorders in women with Pcos and recommend routine screening in this population.15 6.2.8 Studies related to quality of life of adolescents with polycystic ovary syndrome. A study conducted on “Quality of life in adolescent girls with Pcos”, A Cross-sectional study of female adolescents conducted at an urban hospital with 97 adolescents girls with Pcos and 186 healthy women. HRQL (health related quality life) scores as determine by the child health questionnaire-child self report form. It says Adolescents with Pcos experience lower HRQL compared with healthy adolescents.3 9 6.3 STATEMENT OF THE PROBLEM: A study to assess the Effectiveness of self instructional module on polycystic ovary syndrome among the adolescent girls in a selected college of Bangalore. 6.4 OBJECTIVES OF THE STUDY: 1. Assess the knowledge regarding poly cystic ovary syndrome among adolescent girls. 2. Assess the effectiveness of self instructional module on polycystic ovary syndrome among adolescent girls. 3. Determine the association between the selected demographic variables with the knowledge of adolescent girls regarding polycystic syndrome. 6.5 OPERATIONAL DEFINITIONS: 1. KNOWLEDGE Refers to the responses of subjects on self administered questionnaire on Pcos. 2. EFFECTIVENESS. . Refers to the gain in knowledge as determined by significant difference in pre test and post test scores. 3. SELF INSTRUCTIONAL MODULE. Refers to a booklet of contents prepared by the investigator and validated by experts. It contains the meaning, signs and symptoms, management and prevention of pcos, which will be provided to the subjects for self reading and gaining information. 4. POLY CYSTIC OVARY SYNDROME. Polycystic ovary syndrome is a complex condition affecting many organ sites in reproductive age women including the hypothalamus, pituitary, ovary, pancreas, peripheral glucose sensitive tissues, and skin in different individuals. 5. ADOLESCENT GIRLS Refers to the first and second year PUC students. 6.6 HYPOTHESES H1 - There will be significant difference between pre test and post test level of knowledge among of adolescent girls regarding Pcos. 10 6.7 ASSUMPTIONS Its is a assumed that 1. Adolescent girls will be willing to express their knowledge regarding polycystic ovary syndrome. 2. Self instructional module increases the knowledge of adolescent girls regarding polycystic ovary syndrome. 6.8 DELIMITATIONS: 1. The study is delimited to adolescent girls only 2. Adolescent girls who are available at the period of study. 3. Measurement of knowledge scores of Adolescent girls once before and after effectiveness of self instructional module. 6.9 PROJECTED OUTCOME 1. The study will enhance the knowledge of Adolescent girls on Pcos and help in increasing autonomy and operate in a desirable manner to achieve positive health. 2. The study will generate new knowledge on attitudes of Pcos among Adolescent girls. 7 MATERIALS AND METHODS 7.1 SOURCE OF DATA Adolescent girls in a selected college of Bangalore. 7.2 METHODS OF COLLECTION OF DATA. 11 7.2.1 SAMPLE CRITERIA Inclusion criteria of the 1. Adolescent girls in a selected college study 2. Adolescent girls available during data collection. 3. Who are willing to participate. 4. Who understand the language Kannada, English and Hindi. 1. Not willing to participate in the study. Exclusion criteria of the 2. Adolescent girls not attending college. study 7.2.2 RESEARCH DESIGN Pre Experimental design. One group pre test and post test design. 7.2.3 VARIABLES UNDER STUDY 7.2.4 INDEPENDENT VARIABLE Self instructional module. DEPENDENT VARIABLES. Knowledge of adolescent girls regarding polycystic ovary syndrome.. ATTRIBUTE VARIABLE Age, socioeconomic status, Education. SETTING OF THE STUDY Study will be conducted in a selected college of Bangalore. 7.7.5 SAMPLE TECHNIQUE The researcher will use convenience sampling technique. 7.2.6 SAMPLE SIZE The sample size consists of 30 Adolescent girls 7.2.7 TOOLS OF RESEARCH Level of knowledge of Adolescent girls about Pcos can be assessed by questionnaire on knowledge of Adolescent girls about Pcos. 7.2.8 COLLECTION OF DATA An informed consent will be obtained from the 12 subjects The process of the study will be explained to the subjects. Structured questionnaire will be administered to the subject to assess the knowledge level. Subsequently to the pre test, a self instructional module on poly cystic ovary syndrome will be given to the adolescent girls. Following this on 4th day the investigator will assess the knowledge score by post test using structured questionnaire. Study duration is of 30 days. 7.2.9 METHOD OF DATA By using descriptive and inferential statistics. ANALYSIS AND The plan of data analysis will be as follows 1. Organize the data in a master sheet / PRESENTATION computer 2. Frequencies and percentages for the analysis of background data 3. Mean , median, SD and ‘F’ values to determine the significance 4. Chi-square test to determine the association 7.3 Does the study require any investigation or intervention to be conducted on patients or other human or animals? If so, please describe briefly? The study requires administration of questionnaire 7.4 Has the ethical clearance been obtained from the institutional authorities of the particular institution and students Yes. Ethical clearance and informed consent will be obtained from the institutional authorities and students. Privacy, confidentiality and anonymity will be guarded. Scientific objectivity of the study will be maintained with honesty and impartiality. 13 8 REFERENCES: 1. Robert hurd. Polycystic ovary disease.medline plus medical encyclopedia2006.national library of medicine. US. 8600.rockvillepike Bethesda-20894. 2. Pcos andadolescents. Available from: http:// www.pcos.insulitelabs.com/pcos-and-adolescents.php. 3. Maria E Trent, Micheal Rich, Brym Austin S,Catherin M.Goron. quality of life in adolescent girls with polycystic ovary syndrome [online] 2002 Jun. Available from www.archpediatrics.com. 4. Norman RJ, Dewaily D, Legro RS,Hickey TE. Polycystic ovary syndrome. Lancet 2007Aug25;370(9588):685-97 5. Rodin DA, Bano G, Bland JM, Taylor K Nursley SS.Polycystic ovaries and associated metabolic abnormalities in Indian subcontinent Asian women. Clin endocrinal(oxf)1998July;49:91-9. 6. Hart R,Hicky M,Franks S, Definitions, Prevalence and symptoms of polycystic ovaries and polycystic ovary syndrome[online].2004oct 5[cited on 2007june11];Available from http//www.ncbi.nlm nih gov/sites/entrez?. 7. 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Jones GL,Hall IM, Balen AH,Ledger WL.Health related quality of life measurement in women with poly cystic ovary syndrome;A systematic review.[online]2007sep28[cited 2007june11];Available from http://www.ncbi.nlm nih.gov/sites/entrez? 15. Hollinrake E, A bren A ,Mafeld M,Van voorish BJ,Dokras A. Incresed risk of depressive disorders in women with polycystic ovary syndrome.Fertysterij,2007june 6;87: 1369-76. 16. Creatsas G,Deligeoroglou E. Polycysticovarian syndrome in adolescents.curr opine obstetgynecol2007oct5;19:420-6. 17. Danial R Mishell J R,Arthur L, Hurbst,Thomas H,Kirbeb Bensons.Year book of obstetrics gynecology and women’s health 2000.Mosby publication;2000.P-272-3. 18. Zagar AH,Gupta VK,Wani AI,Masood SR,Bashir mi,Laway BA,Gania MA,Salahuddin M.Prevalence of ultrasonography proved polycystic ovaries in North Indian women with type 2 diabetes mellitus. prodReprod biol / Endocrinol/2005aug11;3:35. 19. Stankiewicz M,Norman R,Diagnosis and management of polycystic ovary syndrome: A practical guide[online]2006[cited on 2007june11]; Available from http://www.ncbi.nlm.nih.gov/sites/entrez? 20. Harwood K, Vuguin P,Dimartino.Nardi J.Current approaches to the diagnosis and treatment of polycystic ovarian syndrome in youth.HormRes2007April5;68(5):209-17. 21. Bharathi SP,Ravichandran BS,Abeetha M.Benefits of kayakalpa yoga over polycystic ovary syndrome patients. Available from http://www.venthathiri.org/vethathirianscience/benefitsofkayakalpayog 15 16