ScoliosisNCT07676019
Psychometric Properties of the Turkish Version of the Staffordshire Adolescent Idiopathic Scoliosis Questionnaire
An observational study of Scoliosis and Quality of Life, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Scoliosis, Quality of Life
- What is being tested?
- Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2026to 2 Mar 2027
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
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
Acibadem University
Istanbul, Turkey, +90
Nuray ALACA, 05324251290, nuray.alaca@acibadem.edu.tr
About this study
Official title: 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.
- Conditions
- Scoliosis, Quality of Life
- Being tested
- Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS)
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis | Not described Receives: Other: Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and 15-21 days after baseline.
Secondary outcomes (2)
Scoliosis Research Society-22 Questionnaire
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.
Measured: Baseline (Day 1)
Spinal Appearance Questionnaire
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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start2 Jul 2026 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676019
- Sponsor's protocol ID
- 2026/10/470
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Turkish Version of the Staffordshire Adolescent Idiopathic Scoliosis Questionnaire (SQAIS)
- ClinicalTrials.gov ID
- NCT07676019
- Acronym / sponsor ID
- 2026/10/470
- Conditions
- Scoliosis, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 2 Jul 2026 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 30 Jun 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoliosis | – | Other: Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS) |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Turkish Version of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS)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. | Other | Scoliosis |
Primary outcome
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.
2 secondary outcomes
Scoliosis Research Society-22 Questionnaire
Time frame: Baseline (Day 1)
Spinal Appearance Questionnaire
Time frame: Baseline (Day 1)
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 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Scoliosis and Quality of Life, run by Acibadem 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 3 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: opening soon, as of the sponsor's last update on 30 Jun 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 Nuray ALACA (05324251290, nuray.alaca@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (time frame: Baseline (Day 1) and 15-21 days after baseline.). 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 30 Jun 2026.