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Completed

NCT Number: NCT04846296

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

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.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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.

Other names: the Quality of Life Profile for Spinal Deformities

Primary outcomes

  1. Turkish adaptation, validity and reliability of QLPSD

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Collaborators

  • Istanbul University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2021
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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