Hand BurnNCT07329400
Turkish Adaptation and Validation of the Burnt Hand Outcome Tool (BHOT)
An observational study of Hand Burn and Hand Injuries, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Burn, Hand Injuries, Burn Injuries
- What is being tested?
- Burnt Hand Outcome Tool (BHOT) - Turkish Version
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years and older with a history of second-degree or higher burn injury in one or both hands who are receiving outpatient or inpatient care at the burn unit. All participants are able to read and understand Turkish and provide informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital (Konya Şehir Hastanesi)
Konya, Meram
Pariya Pouriyamanesh, +905538304970, fzt.pariya@gmail.com
About this study
Official title: 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.
- Conditions
- Hand Burn, Hand Injuries, Burn Injuries
- Being tested
- Burnt Hand Outcome Tool (BHOT) - Turkish Version
- Keywords
- Hand Burns, Burnt Hand Outcome Tool (BHOT), Validation Study, Reproducibility of Results, Burn Injuries
- Medical subject headings
- Hand Injuries, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burnt Hand Outcome Tool (BHOT) - Turkish VersionOther
Assessment using the Turkish version of the Burnt Hand Outcome Tool (BHOT) for validity and reliability evaluation; no treatment is applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the Turkish Version of the Burnt Hand Outcome Tool (BHOT)
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.
Measured: Baseline , 1 month, 3 months, and 6 months
Construct Validity of Burnt Hand Outcome Tool-Turkish
Construct validity will be assessed using confirmatory factor analysis (CFA) to evaluate the factor structure of the Turkish version of Burnt Hand Outcome Tool.
Measured: baseline, 1 month, 3 months, and 6 months
Secondary outcomes (4)
Convergent Validity With QuickDASH
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Hand Grip Strength
Hand grip strength measured in kilograms (kg) using a hand dynamometer in adults with hand burns.
Measured: Baseline
Sensory Function Assessment
Sensory function of the hand assessed using the Semmes-Weinstein Monofilament Test, reported as monofilament level indicating cutaneous sensory threshold.
Measured: Baseline
Discriminant Validity by Clinical Characteristics
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start17 Nov 2025
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand BurnStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- Konya City Hospital
- Responsible party
- Principal investigator, Pariya Pouriyamanesh, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329400
- Sponsor's protocol ID
- NecmettinEU-FTR-PP-01
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation of the Burnt Hand Outcome Tool (BHOT): A Validity and Reliability Study in Adult Patients With Hand Burns
- ClinicalTrials.gov ID
- NCT07329400
- Acronym / sponsor ID
- NecmettinEU-FTR-PP-01
- Conditions
- Hand Burn, Hand Injuries, Burn Injuries
- Keywords
- Hand Burns, Burnt Hand Outcome Tool (BHOT), Validation Study, Reproducibility of Results, Burn Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- Konya City Hospital
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older with a history of second-degree or higher burn injury in one or both hands who are receiving outpatient or inpatient care at the burn unit. All participants are able to read and understand Turkish and provide informed consent.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burnt Hand Outcome Tool (BHOT) - Turkish VersionAssessment using the Turkish version of the Burnt Hand Outcome Tool (BHOT) for validity and reliability evaluation; no treatment is applied. | Other | – |
Primary outcome
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.
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.
4 secondary outcomes
Convergent Validity With QuickDASH
Time frame: Baseline, 1 month, 3 months, and 6 months
Hand Grip Strength
Time frame: Baseline
Sensory Function Assessment
Time frame: Baseline
Discriminant Validity by Clinical Characteristics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Burn and Hand Injuries, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pariya Puriyamanesh (+905538304970, fzt.pariya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the Turkish Version of the Burnt Hand Outcome Tool (BHOT) (time frame: Baseline , 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.