Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT07080203
Brief Summary:
Study design:
The study building by two design a descriptive exploratory research design and quasi experimental research design were utilized in the present study
Setting of the study:
This study was conducted at the Outpatient Clinics of Sohag university hospital after approval from the Sohag university medical ethics committee and nursing ethics committee.
Subjects of the study
Sampling:
the sample consists of 400 women.
Sample technique:
a convenient sample of all available women attending outpatient clinics at sohag university hospital and according to the pilot study and demand of the women to clinical investigations also authenticity for the P-QOL. Questionnaire the Quasi experimental research design with purposive sample from the convenient sample were used to confirm the diagnosis and make intervention to improve the quality of life for that women .
Tools of study:
Two tools were utilized and filled by researchers for collecting the data of this study.
The First Tool:
Structured interviewing questionnaire developed by the researcher based on relevant literature divided into three parts.
Part I: socio demographic data as; (age, level of education , income , marital status , place of residence, occupation,).
Part II: Medical history: Related to chronic constipation ,chronic cough and other chronic diseases.
Part III: obstetrical history: Includes (number of pregnancies, number of vaginal deliveries, inter pregnancy interval)
The second Tool: P-QOL. questionnaire adopted from (Digesu et al., 2005) and consist of 9 items (General health perceptions, Prolapse impact, Role limitations, Physical limitations, Social limitations, Personal relationships, Emotions, sleep /energy , Severity measures) then after detect and to determine the degree of prolapse were referred to gynecological clinic to be investigated by clinical supervisor.
Scoring system:
The researcher collected data from patients to complete the P-QOL questionnaire to assess how much their symptoms (if present) were affecting them. Responses ranged from ''not at all, through ''slightly'', ''moderately'' to ''a lot'', from very good to very poor and never to all the time. Therefore, a four- or five-point scoring system according each item was used for severity measurement of uterine prolapse symptoms. Scores in each domain range between 0 and 100. A high total score indicates a greater impairment of quality of life, while a low total score indicates a good quality of life.
* A score from 0 to 50 indicates women has good quality of life with no symptoms of uterine prolapse
* A score more than 50 indicates women has impairment of quality of life and need to clinical evaluation to confirm the degree with symptoms of uterine prolapse.
Tool Validity and Reliability:
Validity:
The validity was assessed by measuring levels of missing data, comparing symptom scores between affected and asymptomatic women and lastly comparing symptom scores with objective vaginal examination related to stages of uterine prolapse, in the symptomatic group, as described in the POP-Q, using Spearman's correlation coefficient (construct validity). (Digesu et al., 2005).
Reliability:
The reliability of the questionnaire was assessed by its internal consistency using the Cronbach alpha and stability using a 2-week test-retest analysis. Internal consistency refers to the degree of correlation between the items. Therefore, it is expected that items forming a domain should moderately correlate with each other, but should contribute independently to the overall domain score. A perfect correlation of 1.0 indicates that the questions are measuring an identical construct. A poor correlation instead suggests that the items are testing different traits. A Cronbach alpha of \>0.7 has been recommended as acceptable. (Digesu et al., 2005).
Pilot study:
It was carried out on 40 women to understand the feasibility of participant recruitment regarding study design and to ensure that the respondents for the pilot should be as similar as possible for the actual items in terms of age, gender, education, socioeconomic (income) status. It also helped in the estimation of the time needed to fill the tool .Women who participated in pilot study were included in the main study because because no modifications needed to be performed and five cases of them have uterine prolapse symptoms need clinical examination.
Detailed Description:
* Preparatory phase It included reviewing past, current, local and international related literature and theoretical knowledge of various aspects of the study using books, articles, internet, periodicals and magazines regarding of the effects of uterine prolapse symptoms based on degrees and their relation to quality of life in the childbearing period . the researcher attended the previously mentioned setting twice or sometimes three times per week from 8 Am to 12 p.m .
* First step The researcher obtained approval from the dean of the Faculty of Nursing at Sohag University, Dean of the Faculty of Medicine at sohag university and director of sohag university hospital
* Second step The researcher met with all the women in the childbearing period convenient in outpatient clinics twice weekly and sometimes three times per week after the researcher introduced herself, explained the goal of the study to them , and obtained formal consent from each women who agreed to participate in the study. Confidentiality of any information obtained was guaranteed, and subjects were informed of their right to participate or not to participate in the study. Anonymity is also assured, and this data will only be used for the study.
Data was collected and filled by the researcher via interviewing questionnaire at the beginning the women were asked about their sociodemographic data and medical and obstetric history then they were asked on items included in P-QOL questionnaire which was adopted from (Digesu et al., 2005) and consists of 9 items (General health perceptions which include questions such (How would you describe your health at present and How much do you think your prolapse problem affect your life) , Prolapse impact which include urinary and vaginal symptoms such (Going to the toilet to pass urine very often, Urgency:A strong desire to pass urine, Urge incontinence ; urinary leakage associated with a strong desire to pass urine, Stress incontinence ; urinary leakage associated with coughing, Feeling a bulge / lump from or in the vagina , Heaviness or dragging feeling as the day goes on from the vagina or the lower abdomen, Vaginal bulge interfering with you emptying your bowels, Discomfort in the vagina which is worse when standing and relieved by lying down, Poor urinary stream, straining to empty your bladder and Urine dribbles after emptying your bladder) ,bowel and vaginal symptoms which include (Bowels do not feel completely empty after opening, Constipation ;difficulty in emptying, Straining to open your bowels, vaginal bulge which gets in the way of sex, Lower backache worsens with vaginal discomfort, Do you help empty your bowels with your fingers? How often do you open your bowels? , Role limitation which include questions such as ( To what extent does your prolapse affect your household tasks ( e.g. cleaning ,shopping )? And Does you prolapse affect your job or your normal daily activities outside the home ?) , Physical and social limitations which include questions such as (Does your prolapse affect your physical activities (e.g. going for a walk , run , sport , gym etc.)?, Does your prolapse affect your ability to travel, Does your prolapse limit your social life? And Does your prolapse limit your ability to see/visit friends ?) , Personal relationships which include such as(Does your prolapse affect your relationship with your partner ?, Does your prolapse affect your sex life? and Does your prolapse affect your family life?.) , Emotions which include questions such as ( Does your prolapse make you feel depressed, Does your prolapse make you feel anxious or nervous ? and Does your prolapse make you feel bad about you self?) , sleep /energy questions which include (Does your prolapse affect your sleep ?and Do you feel worn out / tired ?) ,Severity measures which include(Use tampons /pads /firm knickers to help?, Do you push up the prolapse?, Pain or discomfort due to the prolapse ? and Does the prolapse prevent you from standing ?).
After the women answered these questions. According to the reported symptoms by the women the researcher knew if the women have symptoms of uterine prolapse or no and have good quality of life or impairment in quality of life according to scoring system in P-QOL questionnaire . Once the questionnaires had been completed and collected, an explanation of what had been measured was given to the women and assurances were given also and the women with uterine prolapse symptoms and have impairment of quality of life were told that they need to clinical examination to confirm if they have uterine prolapse or no and if they have uterine prolapse which degree they have. Moreover the researcher explained by booklet for the women about uterine prolapse definition ,causes, risk factors, degrees, symptoms and how to prevent themselves from having uterine prolapse Then the researcher told the women having uterine prolapse symptoms to be in contact with her to find near available time with the physician for clinical examination .
-Third step The researcher was in contact with the physician to determine an available time to examine cases which have symptoms of uterine prolapse . and then the researcher told the women through their mobile phone about time for examination determined by physician .that was about three times monthly every time about four or five cases according to accessibility came for clinical examination .Examination for cases occurred in two places in Feto-maternal unit in special clinics and department of obstetric and gynecology (OBGYN) in sonography room . when the women arrived to hospital waiting room during this the researcher repeated what had been explained for the women about uterine prolapse definition ,causes, risk factors, degrees, symptoms and how to prevent themselves from having uterine prolapse after that the women came to the examination room which was prepared before women coming with sterile Cusco-speculum according to number of cases and sterilization of examination bed then women are asked to empty her bladder before entering the room then women entered the room and nurse in examination room asked the women to keep her clothes down and put women in supine position with knee slightly flexed and rotated outward with complete keeping privacy during examination . after that physician wear gloves and begin to examine cases per vaginal examination at first uses transvaginal sonography to screen uterus ,ovaries ,fallopian tube ,endometrium for any lesion ,polyp, cyst and myoma then sterile Cusco-speculum with lubricated gel slightly inserted through the vagina to determine uterine decent especially in cases of first degree uterine prolapse where cannot be seen through the vaginal decent because in first degree uterine prolapse cervix is below ischial spine then prevaginal examination is done and physician put his fingers in posterior wall of the vagina and ask women to cough to see if there is any vaginal bulge this help to determine if women have cystocele or no and repeat this in anterior wall of the vagina to detect if women has rectocele or no. then physician removed gloves and ask women to be in comfortable position . with examination physician detected some problems which women have as urinary tract infection such as vaginitis or cervicitis so physician described proper treatment for such cases as well as told and reassure women how to manage uterine prolapse according to degree and the researcher repeated what physician has said to women and help in direction of cases to follow physician instructions Lastly, after finishing lots of thanks were given to women for their cooperation.
There were about 50 women which don't have any uterine prolapse symptoms asked if they allowed to do clinical examination to confirm that if they have uterine prolapse or no so clinical examination was done for them and illustrated that they actually don't have uterine prolapse .
Administrative design:
An official letter approval was obtained from Dean of the Faculty of Medicine and Faculty of Nursing at Sohag University to directors of previous setting in Sohag University. This letter included a brief explanation of the objectives of the study and permission to carry out the study
Study:
NCT07080203
Study Brief:
Protocol Section:
NCT07080203