NCT07676019

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Mar 2027

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2027

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 24, 2026

Last Update Submit

June 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis

    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 Outcomes (2)

  • Scoliosis Research Society-22 Questionnaire

    Baseline (Day 1)

  • Spinal Appearance Questionnaire

    Baseline (Day 1)

Study Arms (1)

Scoliosis

Other: Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS)

Interventions

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.

Scoliosis

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adolescents aged 10-19 years with a diagnosis of Adolescent Idiopathic Scoliosis (AIS) who are being followed in orthopedic and rehabilitation clinics

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Turkey, +90, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Nuray Alaca

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

July 2, 2026

Primary Completion (Estimated)

January 2, 2027

Study Completion (Estimated)

March 2, 2027

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations