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NCT04782219

Validity of Turkish Version of PROMIS-29 Measure

Completed Last updated 9 May 2023
What this trial tests

trial in Musculoskeletal Diseases in 100 participants. Completed in 30 May 2021.

Timeline
20 March 2021
Primary endpoint
30 April 2021
30 May 2021

Quick facts

Lead sponsorBahçeşehir University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date20 March 2021
Primary completion30 April 2021
Estimated completion30 May 2021
Sites1 location across Turkey (Türkiye)

Conditions studied

Sponsor

Bahçeşehir University

Who can join

Adults 18 to 80, any sex, with Musculoskeletal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be carried out on 100 patients with chronic musculoskeletal disorders who applied to Acıbadem Maslak Hospital Orthopedics and Traumatology Department. Demographic information (age, education level, occupation, marital status) will be obtained from the patients, they will be asked whether they have a chronic musculoskeletal disease diagnosed by the doctor, and they will be asked to fill in the PROMIS 29 and SF-36 v2 questionnaires. The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS (physical function, depression, anxiety, fatigue, sleep disorder, participation in social activities and pain interaction) and 1 question from the intensity of pain. Each item has 5 answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20. SF-36 is the most widely used scale to assess general health status, and 36 items question 8 content (physical function, physical role, pain, general health, social function, energy / fitness, social function, emotional role, mental health). The Turkish translation of the PROMIS 29 questionnaire is presented in ANNEX-2. The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern University according to the FACIT translation method. Its Turkish translation was obtained from Northwestern University by signing a license agreement for use in scientific research. Participants will first be asked to sign the informed consent form electronically. PROMIS 29 and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform. The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation with the SF-36 v2, a similar general health profile questionnaire. To evaluate inter-rater test-retest reliability, both scales will be filled in by patients a second time between 7-14 days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Musculoskeletal Diseases

Currently open trials in the same condition.

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Data sources for this page

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