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

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04846296
Collaborator
Istanbul University (Other)
105
Enrollment
1
Location
17
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
105 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
Actual Study Start Date :
Apr 15, 2021
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
study group

Between 10-20 years old Cobb angle >10 degrees or more Being treated with conservative or surgical treatment for spinal deformities Accepted to answer the questionnaire

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.
Other Names:
  • the Quality of Life Profile for Spinal Deformities

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Turkish adaptation, validity and reliability of QLPSD [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged between 10-20 years old

    • Cobb angle >10 degrees or more

    • Being treated with conservative or surgical 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kanuni Sultan Suleyman Training and Research Hospital Istanbul Turkey 34303

    Sponsors and Collaborators

    • Kanuni Sultan Suleyman Training and Research Hospital
    • Istanbul University

    Investigators

    • Principal Investigator: Merve Damla Korkmaz, 1, Kanuni Sultan Suleyman Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Merve Damla Korkmaz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04846296
    Other Study ID Numbers:
    • KAEK/2021.04.121
    First Posted:
    Apr 15, 2021
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merve Damla Korkmaz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
    quality of life
    scoliosis
    spine
    validation
    adaptation
    Additional relevant MeSH terms:
    Scoliosis
    Congenital Abnormalities

    Study Results

    No Results Posted as of Jun 3, 2022