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NCT04846296 Clinical Trial

The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities

Quality of Life Clinical Trial

Official title:
The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04846296
Other study ID # KAEK/2021.04.121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date November 15, 2022

Study information
Verified date December 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date November 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 16 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It 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.

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul

Sponsors (2)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Turkish adaptation, validity and reliability of QLPSD The questionnaire 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. Higher scores indicate poorer QoL.		 1 day
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