Arabic Version QOL Questionnaire Chronic Wound

Completed

• Conditions: Chronic Wound

• Registration Number: NCT06838234
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to Help clinician modification of treatment through assess the validity and reliability of Arabic version of 17 items QOL questionnaire in patients with chronic wound. It translated to many languages but not present in form of arabic version.

Detailed Description

The study will be cross sectional.participants: 100 patients according to sample size calculations suffering from chronic wound with age between 40-60 years. Using the minimum acceptable ICC of 0.75, expected ICC of 0.85, significance level 0.05, statistical power 80% and number of repetitions 2, the required sample size is about 100 subjects.The patients who met the inclusion criteria will be recruited. The purpose, significance, and procedures of the study will be explained to them, and written informed consent Will be obtained before enrollment.The researcher will measure the wounds and collect disease-related data during dressing changes. The participants will then be asked to fill out the questionnaires by themselves or with the help of the researcher.Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much). On obtaining at least 75% response, the researcher calculated a second-order global score as well as scores for every dimension as the mean of the respective responses. Higher scores indicated greater impairment of the quality of life.

Study Timeline

• Study Start: 2024-08-02
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-09
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who suffering from chronic wound at least 1 month prior to study enrollment,
• Patients aged between 40-60 years .Provision of written informed consent. .All participants will be able to read and write in Arabic language. .All participants can understand items of the questionnaire.

Exclusion Criteria

• Patients who had mental illnesses
• Patients who were unable to fill in the questionnaire independently or answered the questions orally .Patient with communication, vision, hearing disorders. .Patient who doesn't fill the questionnaire till the end.
• Patient who were isolated due to infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body subscale	outcome measure will be applied after one month of wound injury	Body subscale include items (1-5). (My wound hurt, my wound had a bad smell , there was a distributing discharge from wound, the wound has affected my sleep , the treatment of the wound has been burden to me) score range from 0 to 4 , score 0 indicate better and score 4 indicate worser
Psyche subscale	outcome measure will be applied after one month of wound injury	Psyche subscale include items (6_10), score range from 0 to 4 , score 0 indicate better and score 4 indicate worser ( The wound has made me unhappy, I have felt frustrated because the wound is taking so long to heal, I have worried about my wound,I have afraid of the wound getting worse or of new wounds appearing,I have afraid of knocking the wound
Day life subscale	outcome measure will be applied after one month of wound injury	Day life subscale include items (11-16)I have been a trouble moving about because of the wound, climbing stairs has been difficult because of the wound, I have had a trouble with day to day activities , The wound has limited my leisure activities , The wound has forced me to limit activities with others, I have felt dependant on help from other. score range from 0 to 4 , score 0 indicate better and score 4 indicate worser

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt