Clinical trial NCT06838234: Arabic Version QOL Questionnaire Chronic Wound
Official title: Validity and Reliability of Arabic Version of the Quality of Life Questionnaire in Patients With Chronic Wound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Wound
Keywords: Validity and reliability. .
Arabic version QOL questionnaire
chronic wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes 100 patients of both sexes with chronic wound with ages between 40-60 years. Recruited from outpatient clinic of Faculty of Physical Therapy Cairo University and El matarya hospital Patients with chronic wound at least one month ( Venus and arterial ulcer , diabetic foot, burn , Post operative wound healing defect)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body subscale
timeFrame: outcome measure will be applied after one month of wound injury
measure: Psyche subscale
timeFrame: outcome measure will be applied after one month of wound injury
measure: Day life subscale
timeFrame: outcome measure will be applied after one month of wound injury
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Assistant Professor at surgery and burn Department , Faculty of Physical Therapy Cairo University
name: Karim I Abo Khalil safaan
role: PRINCIPAL_INVESTIGATOR
References: