- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676019
Psychometric Properties of the Turkish Version of the Staffordshire Adolescent Idiopathic Scoliosis Questionnaire
Psychometric Properties of the Turkish Version of the Staffordshire Adolescent Idiopathic Scoliosis Questionnaire (SQAIS)
Patient-Reported Outcome Measures (PROMs) have gained increasing importance in scoliosis research in recent years. Although widely used instruments such as the Scoliosis Research Society-22 (SRS-22) include domains related to body image, their primary purpose is to assess overall health-related quality of life and functional outcomes. In contrast, the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS) was specifically developed to provide a more detailed and patient-centered evaluation of body image and perceived deformity in individuals with adolescent idiopathic scoliosis (AIS). However, a Turkish version of the questionnaire with established validity and reliability is not currently available.
Therefore, the aim of the planned master's thesis is to conduct the cultural adaptation of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis into Turkish and to evaluate its psychometric properties in adolescents with AIS. The study will involve a systematic process of linguistic translation and cross-cultural adaptation. Subsequently, the validity and reliability of the Turkish version will be assessed through analyses of internal consistency, test-retest reliability, construct validity, and criterion validity.
The findings of this study are expected to provide a valid and reliable instrument for assessing body image and deformity perception among Turkish adolescents with idiopathic scoliosis, thereby contributing an important patient-centered outcome measure to both clinical practice and research.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nuray ALACA
- Phone Number: 05324251290
- Email: nuray.alaca@acibadem.edu.tr
Study Locations
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Turkey
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Istanbul, Turkey, Turkey (Türkiye), +90
- Acibadem University
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Contact:
- Nuray ALACA
- Phone Number: 05324251290
- Email: nuray.alaca@acibadem.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Aged between 10 and 19 years.
- Diagnosed with Adolescent Idiopathic Scoliosis (AIS) by an orthopedic surgeon or spine specialist.
- Able to read and understand Turkish.
Exclusion Criteria
- Diagnosis of congenital, neuromuscular, or syndromic scoliosis.
- History of severe neurological, psychiatric, or cognitive disorders.
- Presence of communication impairments that may interfere with understanding or completing the questionnaires.
- History of major trauma or spinal surgery within the previous 6 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Scoliosis
|
Administration of the Turkish version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis to evaluate body image and perceived deformity in adolescents with idiopathic scoliosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis
Time Frame: Baseline (Day 1) and 15-21 days after baseline.
|
The Turkish version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS) will be administered to assess body image and perceived spinal deformity in adolescents with idiopathic scoliosis.
The questionnaire consists of items evaluating patients' perceptions of their appearance and scoliosis-related concerns.
Item scores are summed to obtain a total score.
Higher scores indicate greater body image disturbance, poorer perception of appearance, and a greater perceived impact of scoliosis-related deformity.
Test-retest reliability will be evaluated by re-administering the questionnaire 15-21 days after the initial assessment.
|
Baseline (Day 1) and 15-21 days after baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scoliosis Research Society-22 Questionnaire
Time Frame: Baseline (Day 1)
|
The Scoliosis Research Society-22 (SRS-22) questionnaire will be used to assess health-related quality of life in adolescents with idiopathic scoliosis.
The questionnaire consists of 22 items distributed across five domains: Function/Activity, Pain, Self-Image/Appearance, Mental Health, and Satisfaction with Management.
Items are scored on a 5-point Likert scale.
Domain scores and a total score are calculated, with higher scores indicating better health-related quality of life, better function, less pain, more positive self-image, and better mental health.
|
Baseline (Day 1)
|
|
Spinal Appearance Questionnaire
Time Frame: Baseline (Day 1)
|
The Spinal Appearance Questionnaire (SAQ) will be used to assess patients' perceptions of spinal deformity and body appearance related to scoliosis.
The questionnaire consists of appearance-related items evaluating perceptions of trunk shape, posture, asymmetry, and overall spinal appearance.
Scores are calculated for individual domains and as a total score.
Higher scores indicate a more negative perception of spinal appearance and greater perceived deformity.
|
Baseline (Day 1)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/10/470
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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