- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Nuray ALACA
- Telefonní číslo: 05324251290
- E-mail: nuray.alaca@acibadem.edu.tr
Studijní místa
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Turkey
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Istanbul, Turkey, Turecko (Türkiye), +90
- Acibadem University
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Kontakt:
- Nuray ALACA
- Telefonní číslo: 05324251290
- E-mail: nuray.alaca@acibadem.edu.tr
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Scoliosis
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Jiný: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis
Časové okno: Baseline (Day 1) and 15-21 days after baseline.
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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.
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Baseline (Day 1) and 15-21 days after baseline.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Scoliosis Research Society-22 Questionnaire
Časové okno: Baseline (Day 1)
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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.
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Baseline (Day 1)
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Spinal Appearance Questionnaire
Časové okno: Baseline (Day 1)
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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.
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Baseline (Day 1)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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