Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05539456
Collaborator
(none)
55
1
2
27.4

Study Details

Study Description

Brief Summary

The aim of the investigator's study was to investigate translating the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old and using it in clinics reliably and validity with a Turkish version of the PedsQL Generic Core (Pediatric Quality of Life Questionnare) in children with Spinal Muscular Atrophy in Turkey

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The PedsQL 3.0 Neuromuscular Module for 2-to 4- year-old will be translated into Turkish by following the language translation steps. First of all, the English form will be translated into Turkish by two people who are fluent in English. Then, the forms translated by another expert in the field will be reviewed. The revised text will be translated from Turkish into English by another person with a good command of English and will be compared with the original scale by the lecturer. If a significant change in meaning is not detected, the scale will be applied to 10 parents. In case of incomprehensible questions, which are reported to be lacking in expression, the scale will be finalized after revision and corrections are made by the research team.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    55 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old: a Quality-of-life Measure for Patients With Spinal Muscular Atrophy in Turkey
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. PedsQLTM 3.0 neuromuscular module for 2-to 4- Year-old [5-10 minutes]

      The module encompasses three scales: About My/My Child's Neuromuscular Disease (17 items), Communication (3 items), About Our Family Resources (5 items). The scale is comprised a parent proxy-report format for children ages 2 to 4 years. Items in all forms are essentially identical but contain slightly different language for first or third person tense. The participants are asked how much of a problem each item had been during the past month. Responses are rated on a 5-point Likert scale across child self-report for children, teens, and parent proxy-reports (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem). Items are linearly transformed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0) so that higher scores indicate better HRQOL.

    Secondary Outcome Measures

    1. PedsQLTM 4.0 generic core scales [5-10 minutes]

      The 23-item PedsQLTM 4.0 Generic Core Scales encompass: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), School Functioning (5 items) The formats, instructions, Likert scales, and scoring methods are the same as those of the PedsQLTM 3.0 Neuromuscular Module. To create the Psychosocial Health Summary Score, the mean is computed as the sum of the items divided by the number of items answered in the Emotional, Social, and School Functioning Subscales.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Having a child with spinal muscular atrophy

    • Having a child between the ages of 2-4

    • Accept to participate in the study

    Exclusion Criteria:
    • Lack of cooperation during work

    • Presence of disease other than SMA, which will prevent participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seval Kutlutürk Yıkılmaz Istanbul Kavacık Turkey 34810

    Sponsors and Collaborators

    • Istanbul Medipol University Hospital

    Investigators

    • Principal Investigator: Seval Kutlutürk Yıkılmaz, Medipol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istanbul Medipol University Hospital
    ClinicalTrials.gov Identifier:
    NCT05539456
    Other Study ID Numbers:
    • E-10840098-772.02-213
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 19, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Istanbul Medipol University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 19, 2022