APPLICATION FOR APPROVAL OF DISSERTATION TOPIC Name of Candidate

APPLICATION FOR APPROVAL OF DISSERTATION TOPIC
Name of Candidate:Dr. Uko, Edidiong Emmanuel
Phone Number:+2347034647506
E-mail:[email protected]
Date of passing the Part I
FMCFM Examination:October 2015
Date of commencement of
Part II Training: November, 2015
Training institution:University of Uyo Teaching Hospital, Uyo.

Proposed Title of Dissertation: ASSESSMENT OF IMPACT OF SEXUAL DYSFUNCTION ON QUALITY OF LIFE OF ADULT FEMALE DIABETIC PATIENTS ATTENDING GENERAL OUT-PATIENT CLINIC OF UNIVERSITY OF UYO TEACHING HOSPITAL.

For completion by Faculty Board Secretary
1.Faculty Approval of supervisor: Signature and Date
2.Date of FMCFM Part II for which the candidate may be eligible:
Faculty Board Secretary:__________________________
Name:____________________Signature Date:________________
SUPERVISORS
Name:Dr O. S. AkinbamiSignature:
Address:Department of Family medicine,
University of Uyo Teaching Hospital,Date:
Uyo.

Name: Dr A. U. IdungSignature:
Address: Department of Family Medicine
University of Uyo Teaching Hospital,
Uyo. Date:
HEAD OF DEPARTMENT
Name:Dr A. U. IdungSignature:
Address:Department of Family Medicine
University of Uyo Teaching Hospital
Uyo. Date:

A PROPOSAL SUBMITTED TO THE FACULTY OF FAMILY MEDICINE, NATIONAL POST-GRADUATE MEDICAL COLLEGE OF NIGERIA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF THE FELLOWSHIP OF NATIONAL POST-GRADUATE MEDICAL COUNCIL OF NIGERIA (FMCFM)
TITLE:ASSESSMENT OF IMPACT OF SEXUAL DYSFUNCTION ON QUALITY OF LIFE OF ADULT FEMALE DIABETIC PATIENTS ATTENDING GENERAL OUT-PATIENT CLINIC OF UNIVERSITY OF UYO TEACHING HOSPITAL.

AUTHOR:DR. UKO EDIDIONG EMMANUEL
FACULTY:FACULTY OF FAMILY MEDICINE
TRAINING
INSTITUTION:UNIVERSITY OF UYO TEACHING HOSPITAL (UUTH),
UYO, AKWA IBOM STATE, NIGERIA

OCTOBER, 2017.

TABLE OF CONTENT
Title page——–i
Introduction——-1
Statement of problem——4
Aim and objectives——5
Materials and methods——5
References——-15
List of abbreviation——-19
Appendices
Informed consent——-20
Questionnaires ——-21

INTRODUCTION
Sexuality is a complex process, coordinated by neurological, vascular, and endocrine systems. Individually, sexuality incorporates family, societal, and religious beliefs. It is altered with aging, health status, and personal experiences.1A distortion in any of these areas may cause sexual dysfunction. The World Health Organization (WHO) has defined sexual health as a state of physical, emotional, mental, and social wellbeing in relation to sexuality and not merely the absence of disease, dysfunction or infirmity.2 Sexual dysfunction is defined as the various ways in which an individual is unable to participate in a sexual relationship as he or she is supposed to.3Sexual and reproductive health and wellbeing are essential if people are to have responsible, safe, and satisfying sex lives.

Female sexual dysfunction (FSD) is defined as disorders of sexual desire, arousal, orgasm and sexual pain, which lead to significant personal distress.4 It is a common, but underestimated problem with adverse effect on the quality of life of women, family and society. The normal female sexual response cycle was reported for the first time in 1966 by masters and Johnson as consisting of four successive phases: excitement, plateau, orgasm, and resolution.4 Modifications made by Kaplan in 1979, split the excitement phase into desire and arousal and eliminated the plateau phase.4 These modifications formed the basis of the Diagnostic and statistical manual of mental disorders, 4th edition (DSM IV) definitions and classifications of sexual dysfunction.5 In 2010, the Third International Consensus of Sexual Medicine accepted revised definitions of FSD, emphasizing a model based on a circular pattern of the sexual female response, in which different phases of sexual function can overlap.6 More recently, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) released newer and revised definitions, in which sexual desire and arousal disorders have been combined into the “female sexual interest/arousal disorder” category, and vaginismus and dyspareunia have been grouped into the “genito-pelvic pain/penetration disorder” category.7,8 All of the sexual dysfunctions outlined in the DSM-5 require a minimum duration of approximately 6 months, and more precise severity criteria must be met in order to provide useful thresholds for making a diagnosis and for distinguishing transient sexual difficulties from more persistent sexual dysfunction.7,8
Sexual difficulties in women appear to be widespread in the society, as they are influenced by both health-related and psychosocial factors; they are also associated with impaired quality of life and interpersonal relationships.8 For many years, the prevalence of FSD was 43% based on data of the National Health and Social Life Survey of 1992 in the U.S.A.9 In Africa, data is rare. In Nigeria, the reported prevalence of sexual dysfunction in women of the reproductive age group is 63%.10FSDs are associated with such risk factors as cigarette smoking, hypertension and its medications, hypercholesterolemia, overweight, increasing age, and diabetes mellitus especially with poor glycemic control.11 FSDs may be associated with Prescription and over-the-counter medications, illicit drugs and alcohol abuse. Gynecologic conditions contribute physically to sexual difficulties.1
Diabetes mellitus is defined as a metabolic disorder of multiple aetiologies characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action or both¹³. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels.14
It can be classified into four broad categories:
Type 1 diabetes (due to Beta-cell destruction, usually leading to absolute insulin deficiency),
Type 2 diabetes (due to a progressive insulin secretory defect on the background of insulin resistance),
Other specific types of diabetes due to other causes, include genetic defects in Beta-cell function, genetic defects in insulin action, diseases of the exocrine pancreas (such as cystic fibrosis), and drug- or chemical-induced (such as in the treatment of HIV/AIDS or after organ transplantation) diabetes mellitus,
Gestational diabetes mellitus (GDM) (diabetes diagnosed during pregnancy that is not clearly overt diabetes).14
Some patients cannot be clearly classified as type 1 or type 2 diabetic. However, difficulties in diagnosis may occur in children, adolescents, and adults, with the true diagnosis becoming more obvious over time. Type 2 diabetes mellitus is the most common form of diabetes. Diabetes is usually diagnosed based on WHO criteria, using the presence of symptoms of hyperglycaemia (e.g. polyuria, polydipsia, unexplained weight loss, visual blurring, genital thrush, lethargy) AND raised venous glucose detected once-fasting ?7mmol/L or random ?11.1mmol/L OR raised venous on 2 separate occasions-fasting ?7mmol/L, random ?11.1mmol/L or oral glucose tolerance test (OGTT)-2 hour value ?11.1mmol/L.15 Recently, an International ExpertCommittee added the HbA1C (threshold 6.5%) as a third option for diagnosis of diabetes.16 HbA1c relates to mean glucose level over previous 8 weeks.All types of diabetes mellitus are associated with micro vascular and macro vascular complications including sexual dysfunction.17
The World Health Organization (WHO) defines quality of life as individuals’ perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards and concerns.18 However, the term is used in reference to healthcare as health related quality of life (HRQOL). It refers to how the wellbeing of an individual is affected by a disease, a disability, or disorder over time.19Individually, HRQOL includes physical and mental health perceptions and their correlates- including health risks and conditions, social supports, functional status, and socioeconomic status.
There has been an increasing interest in research on HRQOL of individual with chronic illnesses in Africa including Nigeria.20,21 A chronic medical condition such as Diabetes mellitus, its complications and medications is reported toaffect the quality of life of individuals.22,23 However, reports on FSD and studies on how FSD affects the wellbeing of diabetic adult females in Akwa Ibom state are scarce in scientific literature. This study intends to assess the impact of FSD on the health related quality of life of female diabetic patients attending the Family Medicine General Outpatient clinic of University of Uyo Teaching Hospital, Akwa Ibom State, Nigeria.

STATEMENT OF THE PROBLEM
The number of adults living with diabetes mellitus has quadrupled since 1980 from 108 million to 422 million adults.24This dramatic rise is largely due to a rise in type 2 diabetes mellitus.25 In Nigeria, the combined prevalence for male and female is 4.3%. Prevalence of 4.3% for the female population is demonstrated. In the USA, People with diagnosed diabetes, on average, have medical expenditures approximately 2.3 times higher than what expenditures would be in the absence of diabetes mellitus.26 Diabetes mellitus is a major cause of micro and macro vascular diseases affecting nearly every system in the body.27 It is the commonest cause of erectile dysfunction in men and is also responsible for reduced libido, low arousability, reduced vaginal lubrication, orgasmic dysfunction and dyspareunia in women through diabetic autonomic neuropathy.27
The prevalence of sexual dysfunction in people with diabetes mellitus is higher than in the general population.28 Although impaired sexual function in men is a well-documented complication of diabetes mellitus, the sexual problems of women with diabetes mellitus have received much less attention in research and clinical practice.29 The aetiology of female sexual dysfunction in diabetics varies greatly across cultures, with the incidence of sexual dysfunction in women with diabetes mellitus generally linked less to organic factors and more to psychological factors, especially co-existing depression.30 The prevalence of sexual dysfunction in diabetic women is estimated to be 20-80%.31Despite over 70 years of investigations in the field of diabetes mellitus in women, sexual dysfunction has remained a controversial issue.31
In Nigeria, comparative hospital based studies in females compared to non-diabetics in a study done at the University of Ilorin teaching hospital reports that diabetes significantly impairs the sexual performance of the Nigerian women afflicted with the disease.32 A prevalence of 77.52% in Nasarawa, north-central, Nigeria,6.6% in Benin, south-south, Nigeria and 88% in Lagos, south-west, Nigeria, have been reported respectively.11,33,34 Reports on the impact of sexual dysfunction on the quality of life among adult diabetic female patients in Uyo are scarce in scientific literature.

AIM AND OBJECTIVES OF STUDY
Aim: To assess the impact of sexual dysfunction on the quality of life among adult female diabetics attending the Family Medicine Clinics of the University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria.

SPECIFIC OBJECTIVES:
To determine the social demographic characteristics of adult female diabetic patients.

To determine the hospital prevalence of sexual dysfunction in adult female diabetic patients attending the general outpatient clinic (GOPC) of UUTH.

To determine the types of sexual dysfunction among identified respondents
To assess the relationship between sexual dysfunction and blood sugar control among respondents.

To assess the impact of sexual dysfunction on health related quality of life of respondents.

MATERIALS AND METHODS
STUDY AREA:
This study will be conducted in the Family Medicine General Outpatient clinic of the University of Uyo Teaching Hospital. The Family Medicine clinics consist of the general outpatient clinic, the national health insurance scheme clinic, and the staff clinic. The University of Uyo Teaching Hospital is a 700 bed hospital occupying 43 hectare of land. It currently serves a population of over 4 million people in the South-South geo-political zone of Nigeria. The hospital was established in 1996 as a State Specialist Hospital. It was granted the status of a Federal Medical Centre in 1997 and later a Teaching Hospital by the Federal Government of Nigeria in 2007.
It has been accredited by both the National Postgraduate Medical College of Nigeria and the West African College of Physicians and Surgeons to train Specialists in various fields of medicine including Family Medicine.
Target Population: The target population will be female patients aged between 18 and 60 years, who attend the general outpatient clinic (GOPC) of the University of Uyo Teaching Hospital over a three- month period. According to unpublished data from the health information and management department of the UUTH, a total of 21,919 patients attended the general outpatient clinic in 2016, 10,928 of whom were adult females.

Study Population: The study population will include a sample of females aged between 18-60 years who have registered for treatment and have been diagnosed of diabetes mellitus at the general outpatient clinic (GOPC) during the study period. According to data available from the health information management department of the UUTH, the total number of female diabetics that attended the GOPC in 2016 was 1564. The average monthly attendance was 130. Using this projection, a total of 390 patients will be seen during the three months of study.

Study Design: The study will be cross-sectional study.

Estimation of Sample Size: The sample size (nf) will be determined using the lesliekish statistical formula below:35
nf= __n__
1 + n
N
Where; nf= the desired sample size when the population is less than 10,000.

n =normal sample size when population is more than 10,000.

N= the entire population of female diabetic patients (1564).

n is calculated using the formula (n= z²pq/d²)35
Where n= minimum sample size for statistically significant survey.

Z= normal deviant at the proportion of 95% confidence interval= 1.96.

P= 6.6%proportion in the target population estimated to have particular characteristic (in this study, prevalence of 6.6%33 was used).

q =1.0 – p
d=degree of accuracy desired (set at 0.05 on this study).

Therefore the desired minimum sample size
n =1.962 x 0.066x( 1 –0.066)
0.052
= 0.2535 x 0.066= 0.236769
0.0025 0.0025
n = 94.7 = 95
nf= __n__ =95=95 =95=89.53=90
1 + n1+95 1+0.061 1.061
N 1564
The minimum sample size will be 90.

To compensate for non-response and incomplete response, ten percent (10%) of the minimum sample size will be added. A total of not less than 99 respondents will be recruited for the study.

Sampling Technique:
A systematic sampling technique will be used to recruit respondents for the study. The sampling interval (K) will be calculated using the formula: K=N/n
Where
N = estimated population size for study period (average monthly clinic attendance x duration of study) = 390
n = selected sample size =99
K= 390/99 = 3.9 = 4
Respondents will be selected using systematic random sampling method with a sampling interval of 4.

Numbers ranging from 1 to 4 will be assigned to the first four respondents who meet the inclusion criteria. The first respondent will be chosen by simple balloting which will be done by randomly picking one of the assigned numbers. Subsequently, every 4th respondent will be recruited into the study.

Where, however, such a respondent is below ;18 years of age or above 60 years of age, the respondent will be dropped. Then the next respondent that meets the inclusion criteria will be recruited.
Inclusion Criteria:
All consenting female patients with established diabetes mellitus
Respondents between 18 and 60 years of age.

Exclusion criteria:
Adult females with Emergency medical conditions who require immediate medical intervention.

Adult females with diabetes mellitus that are pregnant.

STUDY PROTOCOL
Informed consent form- Appendix-A
A semi-structured pre-tested questionnaire- Appendix-B.

This will comprise of4 sections namely;
Social demographic variables such as age, sex, income, occupation, education, ethnic group, etc.

Female sexual function index
World Health Organization quality of life instrument (short version WHOQOL-Bref).

Clinical data recording form.
A weighing scale with stadiometer for weight and height measurement.

Mercury sphygmomanometer and stethoscope for blood pressure measurement.

Glycated hemoglobin will be measured using the colorimetric analytical method.

Fasting plasma glucose will be measured using thee glucose oxidase teset
Ethical approval form – Appendix-C
This will be a hospital based cross- sectional study which will be carried out at the general outpatient clinic of the University of Uyo Teaching Hospital over three month period.

A semi-structured questionnaire will be administered to each eligible respondent by the author or a trained female assistant (a doctor or nurse) in comfortable and strict professional environment after they have been informed of the purpose, content and confidentiality of the study. The weight and height of each subject in light clothing without shoes will be measured by trained assistants. The weight obtained will be recorded in kilograms (kg) to the nearest 0.1kg and the height will be recorded in meters (m) to the nearest 0.01m from which the body mass index will be calculated as the weight in kg divided by the square of the height in meters.

A pilot study involving 30 subjects will be done at the University of Calabar teaching hospital to correct detected errors in interpretation of the questionnaire.

Sexual function will be measured in the women by using the female sexual function index questionnaire. The female sexual function index (FSFI) is a known instrument assessing sexual function in women using 6 domains and 19 items.36 It was developed for the purpose of assessing domains of sexual functioning such as sexual desire, arousal, lubrication, orgasm, satisfaction, pain in clinical trials. FSFI is available in many languages and multiple researches in different countries such as Finland, Japan, Egypt, Malaysia and Iran support reliability and psychometric validity of the questionnaire in the assessment of key dimensions of female sexual function.36 It has been used in a comparative study in Nigeria.33 It is a specific sensitive and standardized tool for diagnosing female sexual dysfunction. Individual items will be assigned to six domains of female sexual functions: desires, arousal, lubrication, orgasm, satisfaction and pain during sexual intercourse.37The six domains belonging to the female sexual function index (FSFI) questionnaire are defined in the following lines.

Domain 1: sexual desire: (Q1+Q2);implying the wish/wanting to engage in a sexual experience, receptivity towards sexual initiation or reacting to that as well as fantasizing.The range of score is 2-10 and the score range for sexual dysfunction is 2-4,
Domain 2: sexual arousal: (Q3+Q4+Q5+Q6);signs of attention, activity and excitement. Specifically the questionnaire looks at levels and types of arousal.The range of score are 0-20 and the score range for sexual dysfunction is 0-10, while 11-20 denotes no sexual dysfunction.

Domain 3: lubrication: (Q7+Q8+Q9+Q10); refers to vaginal lubrication that occurs during sexual excitement, presence, quantity or absence of it.The range of score is 0-20 and the score range for sexual dysfunction is 0-10,while 11-20 denotes no sexual dysfunction.

Domain 4: orgasm: (Q11+Q12+Q13);ability to attain orgasms, factors impairing it.The range of score is 0-15 and the score range for sexual dysfunction is 0-8, while 9-15 denotes no sexual dysfunction.

Domain 5: sexual satisfaction: (Q14+Q15+Q16);level of happiness, content with actual sexual life and habits. The range of score is 2-15 and the score range for sexual dysfunction is 2-8, while 9-15 denotes no sexual dysfunction.

Domain 6: sexual pain: (Q17+Q18+Q19);discomfort sensations during intercourse. The range of score is 0-15 and the score range for sexual dysfunction is 0-10, while 11-15 denotes no sexual dysfunction.33
Scores of the six domains will be added to obtain the full scale score. For individual domain scores, scores of the individual items that comprise the domain will be multiplied by the domain factors.37A domain score of zero indicates that the subject reported having no sexual activity during the past month.

The World Health Organization quality of life instrument short version(WHOQOL-Bref) will be used to assess the impact of female sexual dysfunction on general health related quality of life measures among respondents recruited for this study.38 The WHOQOL-Bref has been used as a measure of health related quality of life for other medical conditions in Nigeria.20, 21 It is a 26-item questionnaire, can be used in different cultural settings. It will be adapted as an interviewer-administered questionnaire for this study. It is made up of domains and facets.39 Domains are broad groupings of related facets. A facet is a well-defined specific aspect of life, which a coherent definition could be articulated. Of the 26-items of WHOQOL-Bref, the items on overall rating of QOL and subjective satisfaction with health are not included in the domains, but are used to form one facet on overall quality of life (QOL) and general health.39
There are 4 domains which include the physical, psychological, social relationships and environmental domains.

Domain 1: physical: Q3+Q4 +Q10+Q15+Q17+Q18
Domain 2: psychological: Q5+Q6+Q7+Q11+ Q19+Q26
Domain 3: social relationships: Q20+Q21+Q13
Domain 4: Environment: Q8+Q9+Q12+Q13+Q14+Q23+Q24+Q25
Each of the 26 items of the WHOQOL-Bref has five options to which the patient is expected to respond on 5-point likert-type scale. The WHOQOL-Bref produces a quality of life profile with 4-domain scores of physical health, psychological health, social relationships, and environment. The four domain scores denote an individual’s perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).39The mean score of items within each domain is used to calculate the domain scores. Respondents’ individual scores for each domain are then compared with the possible mean score. A score of mean + 1 standard deviation (SD) on each domain is graded as good and a score of mean – 1 standard deviation is poor.20
Where more than 20% of data is missing from an assessment, the assessment will be discarded. Where an item is missing, the mean of other items in the domain is substituted. Where more than two items are missing from the domain, the domain score should not be calculated (with the exception of domain 3, where the domain score should only be calculated if less than one item is missing).39
Identified respondents with female sexual dysfunction will then be thoroughly assessed by the researcher. Firstly, a thorough medical and sexual history will be obtained. This will be followed by a thorough physical and clinical examination will be carried out on each subject by researcher.

DATA ANALYSIS
Data collected will be collated, coded manually and imputed into the statistical package for social sciences (SPSS) version 22.

Frequencies and percentages will be calculated for categorical variables while mean and standard deviation will be calculated for continuous variables. Association between categorical variables will be tested using chi square where appropriate tables and charts will be used to represent relevant variables. A p-value of ; 0.05 at 95% confidence level will be considered statistically significant.

Ethical consideration
Ethical clearance from the University of Uyo Teaching Hospital Research and Ethical Committee will be sought for and received before commencement of the study.

Consent
Written informed consent will be obtained from the respondents after the objectives of the study have been clearly explained to them
Duration of the study: Three months
Funding of the study: The study will be funded by the researcher.

Relevance of the proposed Study to Family Medicine
Sexual health is a vital part of overall health that should be routinely assessed during medical visits. Sexual health is important, but often neglected and/ or frequently undetected in clinical practice. Female sexual dysfunction is a common problem with detrimental effects on woman’s quality of life.40
Sexual dysfunction (SD) can also be an early sign of DM.38 Sexual problems are common complications of diabetes mellitus in both men and women. Sexual problems in diabetic women mostly include sexual satisfaction and desire disorder, orgasmic and arousal disorder and lubrication disorder. In contrast to male sexual dysfunction, sexual dysfunction has not been well studied among diabetic women and it’s prevalence in diabetic women seems to be slightly underestimated.38
A significant number of diabetics are being managed by family physicians. There is, therefore a need for family physicians to routinely assess sexual problems in female diabetic patients and its effect on patient’s wellbeing. Findings from this study will assist the family physicians in detecting and managing sexual dysfunction in diabetic women.

Limitations Envisaged:
1. This study is a hospital based study. It may be difficult to generalize it to community based subjects.

2. The subjects to be recruited are adult some may not be able to recall their exact ages or year of birth but rather would give estimates.

3. Paucity of literature on impact of FSD on HRQOL
4. FSD detected may not be due to organic causes.

5. This study may not establish whether diabetes is type 1 or type 2.

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Basson R, Berman J, Burnett A, Derogatis L, Ferguson D, Fourcroy J,etal. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. The Journal of urology. 2000; 163(3):888-93.

Raina R, Pahlajani G, Khan S, Gupta S, Agarwal A, Zippe CD. Female sexual dysfunction: classification, path physiology, and management. Fertility and sterility. 2007; 88(5):1273-84.

 Basson R, Wierman ME, van Lankveld J, Brotto L. Summary of the recommendations on sexual dysfunction in women. J Sex Med. 2010; 7(1 Pt 2):314–326.

American Psychiatric Association. Highlights of changes from DSM-IV-TR to DSM-5. 2013. https:www.psychiatry.org/DSM/ APA on May2017, 18.

Maiorino MI, Bellastella G, Esposito K. Diabetes and sexual dysfunction: current perspectives. Diabetes, metabolic syndrome and obesity: targets and therapy. 2014; 7:95.

Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008; 112(5):970–978.

Fajewonyomi BA, Orji EO, Adeyemo AO. Sexual dysfunction among female patients of reproductive age in a hospital setting in Nigeria. Journal of health, population, and nutrition. 2007; 25(1):101.

Amanyam CT, Yohanna S, Obilom RE. Assessment of sexual dysfunction in patients with diabetes mellitus in the general outpatientof dalhatsuaraf specialist hospital lafia. Nigerian journal of family practice. 2016; 7(3):35-42.

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Ogunlana M.O, Adedokun B, Dairo M.D, Odunaiya N. A. profile and predictors of health related quality of life among hypertensive patients in south-western Nigeria. BMC cardiovascular Disorders. 2009; 9(1):25.

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LIST OF ABBREVIATION
DSM……………… ……………….Diagnostic and statistical manual of mental disorders
FPG……………………………….Fasting plasma glucose
FSD……………………………… Female sexual dysfunction
FSFI……………………………… Female sexual function index
GOPC……………………………..General outpatient clinic
HbA1c…………………………….Glycated hemoglobin
HRQOL……………………………Health related quality of life
OGTT……………………………Oral glucose tolerance test
QOL……………………………… Quality of life
SD………………………………. Sexual dysfunction
UUTH…………………………….. University of Uyo Teaching Hospital
WHO……………………………..World Health Organization
WHOQOL………………………..World health organization quality of life
DM…………………………………diabetes mellitus
USA………………………………..United State of America

Appendix A
Informed consent form
Dear Sir/Madam,
PERMISSION TO ENROLL YOU IN A STUDY TITLED “ASSESSMENT OF IMPACT OF SEXUAL DYSFUNCTION ON QUALITY OF LIFE OF ADULT FEMALE DIABETIC PATIENTS ATTENDING GENERAL OUTPATIENT CLINIC OF UNIVERSITY OF UYO TEACHING HOSPITAL”.

I am Edidiong Uko, a doctor working in the department of Family Medicine, University of Uyo Teaching Hospital (UUTH) Uyo. I am requesting your permission to participate in this study titled “Assessment of sexual dysfunction on quality of life of adult female diabetic patients attending Family Medicine outpatient clinic of University of Uyo Teaching Hospital”. You will be expected to answer some questions concerning yourself. All these will help me to find out if you are experiencing any problem with your sexual life since you were diagnosed with diabetes mellitus and have been taking treatment.

There are no physical risks associated with the whole process. You will not be required to pay for this study if you agree to participate. All information that will be collected from this study will be kept confidential.

I am therefore, requesting your permission to participate in this study. Kindly sign or thumbprint this forms if you accept. You have the right to withdraw from this study at anytime without giving any reason and without disadvantage to you.

If you have any question(s) to ask about the study, you may ask now or anytime during the course of the study.

I consent to be part of the study
Signature/thumbprint of participant Signature/thumbprint of researcher
_____________________________ ____________________________
Appendix B
QUESTIONNAIRE
“ASSESSMENT OF IMPACT OF SEXUAL DYSFUNCTION ON QUALITY OF LIFE OF ADULT FEMALE DIABETIC PATIENTS ATTENDING GENERAL OUTPATIENT CLINIC OF UNIVERSITY OF UYO TEACHING HOSPITAL”.

The investigator is a senior Registrar in the department of Family Medicine University of Uyo Teaching Hospital. This study is being conducted with the aim of assessing the impact of sexual dysfunction on quality of life of adult female diabetic patients attending Family Medicine General Outpatient clinic of the UUTH, Uyo.

The study is in partial fulfillment of the requirements for the award of the fellowship of the National Postgraduate Medical College of Nigeria.

All information given by the respondents will be held in strict confidence and anonymity of the respondents will be maintained throughout this work.

Section A
Serial No: ……………………………. ………………
How old are you? …………………
How would you describe your occupation or what kind of work do you do for a living? …………………..

What is your highest level of Educational Attainment?
No formal Schooling Primary school
Secondary school University completed
What is your marital statue? Single Married
Divorced separated
What faith do you profess? Christianity Islam traditional
Which is your tribe Or ethnic group?
Ibibio Igbo Yoruba Hausa Others (specify)
How would you describe your Place of Residency? Urban Rural
What is your average income per month? Less than N 20,000 N21,000-50,000 N 51,000-100,000N 101,000 and above
DO you smoke any form of tobacco products? Yes No
How old were you when you started smoking? Age (years) ……………..

How many cigarettes do you smoke in a day? …………………….

In the past did you ever smoke tobacco? Yes No
How long ago did you stop smoking? ……………………

. Have you ever consumed any form of alcohol drink? Yes No
Have you consumed alcohol within the past 6months to 1 year?
Yes No
What was the frequency of your alcohol consumption?
Daily WeeklyTwo weekly Monthly
Have you ever been told that your blood sugar was raised? Yes No
If yes to question 7, what treatment options were you given?
Drugs (oral hypoglycemic)…………. Insulin……………………………..

Dietary modification……………….. Weight Reduction…………………..

Exercise……………………………. Smoking cessation …………………..

Alcohol cessation ………………… CAM practices……………………….

Section B
Female sexual function index
(Please tick)
The following questions ask about how much you have felt or experienced certain things in the last four weeks.

Almost never/never A few times sometimes Most times Almost always
1. How often did you feel sexual desire or interest? 1 2 3 4 5
Very low/none at all low Moderate High Very high
2. How would you rate your level of sexual desire 1 2 3 4 5
Almost never/never A few times sometimes Most times Almost always/always No sexual activity
3. How often did you feel sexually aroused (“turned on”) during sexual activity/intercourse 1 2 3 4 5 0
Very low/none at all Low Moderate High Very high No sexual activity
4. How would you rate your level of sexual arousal during sexual activity/intercourse 1 2 3 4 5 0
Very low/ no confidence Low confidence Moderate confidence High confidence Very high confidence No sexual activity
5. How confident were you about becoming sexually aroused during sexual activity/intercourse? 1 2 3 4 5 0
Almost never/never A few times Sometimes Most times Almost always No sexual activity
6. How often have you been satisfied with your arousal
(Excitement) during sexual activity/ intercourse? 1 2 3 4 5 0
Almost never/never A few times Sometimes Most times Almost always No sexual activity
7. How often did you become lubricated(“wet”) during sexual activity/intercourse? 1 2 3 4 5 0
Extremely difficult Very difficult Difficult Slightly difficult Not difficult No sexual activity
8. How difficult was it to become lubricated (“wet”) during sexual activity/intercourse? 1 2 3 4 5 0
Almost never A few times Sometimes Most times Almost always No sexual activity
9. How often did you maintain your lubrication (“wetness”) until completion of sexual activity/intercourse? 1 2 3 4 5 0
Extremely difficult Very difficult Difficult Slightly difficult Not difficult No sexual activity
10. How difficult was it to maintain your lubrication (“wetness”) until completion of sexual activity/intercourse? 1 2 3 4 5 0
Almost never/never A few times Sometimes Most times Almost always/always No sexual activity
11. When you had sexual stimulation/ intercourse, how often did you reach orgasm (climax)? 1 2 3 4 5 0
Extremely difficult/
impossible Very difficult Difficult Slightly difficult Not difficult No sexual activity
12. When you had sexual stimulation/ intercourse, how difficult was it for you to reach orgasm(climax)? 1 2 3 4 5 0
Very dissatisfied Moderately dissatisfied Equally satisfied and dissatisfied Moderately satisfied Very satisfied No sexual activity
13. How satisfied were you with your ability to reach orgasm (climax) during sexual activity/ intercourse? 1 2 3 4 5 0
Very dissatisfied Moderately dissatisfied Equally satisfied and dissatisfied Moderately satisfied Very satisfied No sexual activity
14. How satisfied have you been with the amount of emotional closeness during sexual activity with you and your partner? 1 2 3 4 5 0
Very dissatisfied Moderately dissatisfied Equally satisfied and dissatisfied Moderately satisfied Very satisfied 15. How satisfied have you been with your sexual relationship with your partner? 1 2 3 4 5 Very dissatisfied Moderately dissatisfied Equally satisfied and dissatisfied Moderately satisfied Very satisfied 16. How satisfied have you been with your overall sexual life? 1 2 3 4 5 Almost always/always Most times Sometimes A few times Almost never/never Did not attempt
17. How often did you experience discomfort/pain during vaginal penetration? 1 2 3 4 5 0
Almost always/always Most times Sometimes A few times Almost never/never Did not attempt
18. How often did you experience discomfort/pain following vaginal penetration? 1 2 3 4 5 Very high High Moderate Low Very low Did not attempt
19. How would you rate your level of discomfort/ pain during/following vaginal penetration? 1 2 3 4 5 0
Sexual activity includes caressing, foreplay, masturbation and vaginal intercourse.

Sexual stimulation suggests intercourse or self-stimulation.

Sexual intercourse represents the penile penetration of the vagina.

Sexual arousal (“turn on”) represents excitement during or in anticipation of sexual activity.

Lubrication (“wet”) increased vaginal production during sexual arousal.

Orgasm (climax) is a sudden discharge of accumulated sexual excitement resulting in rhythmic muscular contractions in the pelvic region.

As a note, the FSFI does not substitute diagnostic instruments and cannot be used as sexual history questionnaire in clinical evaluations, like those for STD identification. 

Section C
WHOQOL-Bref Questionnaire
The following questions ask how you feel about your quality of life, health, or other areas of your life. I will read out each question to you, along with the response options. Please choose the answer that appears most appropriate. If you are unsure about which response to give to a question, the first response you think of is often the best one.
Please keep in mind your standards, hopes, pleasures and concerns. We ask that you think about your life in the last four weeks.
Very Poor Poor Neither poor nor good Good Very good
1. How would you rate your quality of life? 1 2 3 4 5
Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied
2. How satisfied are you with your health? 1 2 3 4 5
The following questions ask about how much you have experienced certain things in the last four weeks.
Not at all A little A moderate amount Very much An extreme amount
3. To what extent do you feel that physical pain prevents you from doing what you need to do? 5 4 3 2 1
4. How much do you need any medical treatment to function in your daily life? 5 4 3 2 1
5. How much do you enjoy life? 1 2 3 4 5
6. To what extent do you feel your life to be meaningful? 1 2 3 4 5
Not at all A little A moderate amount Very much Extremely
7. How well are you able to concentrate? 1 2 3 4 5
8. How safe do you feel in your daily life? 1 2 3 4 5
9. How healthy is your physical environment? 1 2 3 4 5
The following questions ask about how completely you experience or were able to do certain things in the last four weeks.

Not at all A little Moderately Mostly Completely
10. Do you have enough energy for everyday life? 1 2 3 4 5
11. Are you able to accept your bodily appearance? 1 2 3 4 5
12. Have you enough money to meet your needs? 1 2 3 4 5
13. How available to you is the information that you need in your day-to-day life? 1 2 3 4 5
14. To what extent do you have the opportunity for leisure activities? 1 2 3 4 5
Very poor Poor Neither poor nor good Good Very good
15. How well are you able to get around? 1 2 3 4 5
Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied
16. How satisfied are you with your sleep? 1 2 3 4 5
17. How satisfied are you with your ability to perform your daily living activities? 1 2 3 4 5
18. How satisfied are you with your capacity for work? 1 2 3 4 5
19. How satisfied are you with yourself? 1 2 3 4 5
20. How satisfied are you with your personal relationships? 1 2 3 4 5
21. How satisfied are you with your sex life? 1 2 3 4 5
22. How satisfied are you with the support you get from your friends? 1 2 3 4 5
23. How satisfied are you with the conditions of your living place? 1 2 3 4 5
24. How satisfied are you with your access to health services? 1 2 3 4 5
25. How satisfied are you with your transport? 1 2 3 4 5
The following question refers to how often you have felt or experienced certain things in the last four weeks.

Never Seldom Quite often Very often Always
26. How often do you have negative feelings such as blue mood, despair, anxiety, depression? 5 4 3 2 1
Do you have any comments about the assessment?
The following table should be completed after the interview is finished
Equations for computing domain scores Raw score Transformed score*
4-20 0-100
27. Domain 1 (6-Q3) + (6-Q4) + Q10 + Q15 + Q16 + Q17 + Q18
??+ ??+ ??+ ??+ ??+ ??+ ?? a. = b: c:
28. Domain 2 Q5 + Q6 + Q7 + Q11 + Q19 + (6-Q26)
??+ ??+ ??+ ??+ ??+ ?? a. = b: c:
29. Domain 3 Q20 + Q21 + Q22
??+ ??+ ?? a. = b: c:
30. Domain 4 Q8 + Q9 + Q12 + Q13 + Q14 + Q23 + Q24 + Q25
??+ ??+ ??+ ??+ ??+ ??+ ??+ ?? a. = b: c:
* See Procedures Manual, pages 13-15
Section D
Clinical data recording form
History and clinical Examination
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II. Clinical measurement
Weight :______( kg) Height :_______( m)
BMI: ________ (kg/m²) Blood pressure :_____( mmHg)
HbA1c:______(%)FPG: ________ (mmol/L)
III. Focused History
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IV. General Examination Findings
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V. Focused Examination of systems
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