Quality of Life Assessment in Patients With Different Degrees of Pelvic Organ Prolapse

NCT07080203 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Degree of Uterine Prolapse and Its Effect on Quality of Life

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Eligibility

Min Age
18 Months
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080203 on ClinicalTrials.gov