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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05439434
Other study ID # FOPQC-SF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2022
Est. completion date June 15, 2023

Study information

Verified date September 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to question the Turkish validity and reliability of the "The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in the study. The sample size of this study was determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity Score.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 15, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria: - Being diagnosed with JIA according to the ILAR classification - 7-18 years old - Agree to participate in the study Exclusion Criteria: - Psychiatric illness that may affect cooperation, - Those with heart failure and lung pathology at a level that will affect their daily life activities

Study Design


Intervention

Other:
Fear of Pain Questionnaire for Children Short Form
administering the questionnaire twice, one week apart.

Locations

Country Name City State
Turkey Pamukkale University Denizli Pamukkale

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fear of Pain Questionnaire for Children Short Form It consists of 10 items in total. All items are scored between O-4. Higher scores indicate higher levels of pain-related fear and avoidance. 10 minutes
Secondary Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module Total score ranging from 0-100. High scores mean high quality of life. 15 minutes
Secondary Juvenile Arthritis Disease Activity Score Total JADAS score ranging from 0-57. Higher score indicates more disease activity. 10 minutes
Secondary Childhood Health Assessment Questionnaire It consists of 8 subtests and 30 questions. It is scored between 0-3. A higher score indicates more disability. 15 minutes
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