Clinical trial NCT04846296: The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
Official title: The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Spinal Deformity
Scoliosis
Keywords: quality of life
scoliosis
spine
validation
adaptation
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2021-04-15
Enrollment: 125
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Aged between 10-16years old with scoliosis who treated by conservative management.

Brief summary: The purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with adolescent idiopathic scoliosis.

Detailed description: The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It contains 21 items in five dimensions: psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21-105.

The QLPSD has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL. This questionnaire is practical and suitable for patients with spinal deformities. As a result we choose to translate the QLPSD into Turkish as it is less costly, practical and time consuming than developing a new tool. QLPSD may be preferred during follow-up of the results of conservative and / or surgical treatments for spinal deformities.

Eligibility criteria: Inclusion Criteria:

* Aged between 10-16 years old
* Cobb angle 10-40 degrees
* Being treated with conservative treatment for spinal deformities
* Being accepted to answer the questionnaire

Exclusion Criteria:

* Being not accepted to answer the questionnaire
* Having any mental disorder to prevent participation the study

Primary outcomes:
measure: Turkish adaptation, validity and reliability of QLPSD
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Merve Damla Korkmaz, 1
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feise RJ, Donaldson S, Crowther ER, Menke JM, Wright JG. Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1310-5. doi: 10.1097/01.brs.0000163885.12834.ca.
citation: Schulte TL, Thielsch MT, Gosheger G, Boertz P, Terheyden JH, Wetterkamp M. German validation of the quality of life profile for spinal disorders (QLPSD). Eur Spine J. 2018 Jan;27(1):83-92. doi: 10.1007/s00586-017-5284-3. Epub 2017 Sep 9.