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NCT Number: NCT06838234

Arabic Version QOL Questionnaire Chronic Wound

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.

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Key information

Conditions

Chronic Wound

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arabic version QOL questionnaire

Other

Arabic version QOL questionnaire The Wound-QoL is a wound-specific questionnaire containing 17 items from which one can derive three subscales and . The items 1-5, 6-10, and 11-16 belong to the subscale body, psyche, and everyday life, respectively

Primary outcomes

  1. Body subscale

    Time frame: 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

  2. Psyche subscale

    Time frame: 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

  3. Day life subscale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Validity and Reliability of Arabic Version of the Quality of Life Questionnaire in Patients With Chronic Wound

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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