- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329400
Turkish Adaptation and Validation of the Burnt Hand Outcome Tool (BHOT)
Turkish Adaptation of the Burnt Hand Outcome Tool (BHOT): A Validity and Reliability Study in Adult Patients With Hand Burns
The goal of this observational study is to evaluate the validity and reliability of the Turkish adaptation of the Burnt Hand Outcome Tool (BHOT) in adults with a history of hand burns. The participant population will include adults aged 18 years and older who have experienced unilateral or bilateral hand burns and can read and understand Turkish.The main questions this study aims to answer are:
Does the Turkish version of the BHOT demonstrate high internal consistency, test-retest reliability, and construct validity? How strongly are BHOT scores associated with objective hand function measures such as grip strength and sensory evaluation? Participants will not be assigned to comparison groups, as this is a methodological validation study.
Participants will: Complete a sociodemographic information form. Complete the Turkish version of the BHOT and the QuickDASH questionnaire. Undergo objective assessments including hand grip strength using a dynamometer and sensory evaluation using Semmes-Weinstein monofilaments. Participate in repeated assessments at baseline, 1 month, 3 months and 6 months for reliability analyses.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pariya Puriyamanesh
- Phone Number: +905538304970
- Email: fzt.pariya@gmail.com
Study Locations
-
-
Meram
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Konya, Meram, Turkey (Türkiye)
- Recruiting
- Konya City Hospital (Konya Şehir Hastanesi)
-
Contact:
- Pariya Pouriyamanesh
- Phone Number: +905538304970
- Email: fzt.pariya@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- History of second-degree or higher burn injury in one or both hands
- Ability to read and understand Turkish
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- History of trauma, surgery, or rheumatologic disease affecting hand function prior to the burn injury
- Age under 18 years
- Cognitive impairment or psychiatric disorder preventing completion of the questionnaires
- Refusal to participate or withdrawal from the study at any time
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliability of the Turkish Version of the Burnt Hand Outcome Tool (BHOT)
Time Frame: Baseline , 1 month, 3 months, and 6 months
|
Total score of the Turkish version of the Burnt Hand Outcome Tool (BHOT-T), a patient-reported outcome measure assessing functional, aesthetic, sensory, and psychosocial outcomes in adults with hand burns. The BHOT-T consists of 20 items, each scored on a Likert scale. Total scores range from 0 to 80, with higher scores indicating worse outcomes / greater negative impact of hand burns on hand function and quality of life. |
Baseline , 1 month, 3 months, and 6 months
|
|
Construct Validity of Burnt Hand Outcome Tool-Turkish
Time Frame: baseline, 1 month, 3 months, and 6 months
|
Construct validity will be assessed using confirmatory factor analysis (CFA) to evaluate the factor structure of the Turkish version of Burnt Hand Outcome Tool.
|
baseline, 1 month, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Convergent Validity With QuickDASH
Time Frame: Baseline, 1 month, 3 months, and 6 months
|
Total score of the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (Quick DASH), a patient reported outcome measure assessing upper extremity disability.
Scores are reported as units on a scale from 0 to 100, with higher scores indicating greater disability.
|
Baseline, 1 month, 3 months, and 6 months
|
|
Hand Grip Strength
Time Frame: Baseline
|
Hand grip strength measured in kilograms (kg) using a hand dynamometer in adults with hand burns.
|
Baseline
|
|
Sensory Function Assessment
Time Frame: Baseline
|
Sensory function of the hand assessed using the Semmes-Weinstein Monofilament Test, reported as monofilament level indicating cutaneous sensory threshold.
|
Baseline
|
|
Discriminant Validity by Clinical Characteristics
Time Frame: Baseline
|
Discriminant validity will be evaluated by comparing total scores of the Turkish version of the Burnt Hand Outcome Tool (Burnt Hand Outcome Tool - Turkish version, BHOT-T) across predefined clinical subgroups, including burn severity, history of skin grafting, and working status.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NecmettinEU-FTR-PP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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