Back to resultsTurkish Reliability and Validity of FOPQC-SF
Primary Purpose
Fear, Pain, Juvenile Idiopathic Arthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fear of Pain Questionnaire for Children Short Form
Sponsored by
About this trial
This is an interventional other trial for Fear
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Total score ranging from 0-100. High scores mean high quality of life.
Juvenile Arthritis Disease Activity Score
Total JADAS score ranging from 0-57. Higher score indicates more disease activity.
Childhood Health Assessment Questionnaire
It consists of 8 subtests and 30 questions. It is scored between 0-3. A higher score indicates more disability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05439434
Brief Title
Turkish Reliability and Validity of FOPQC-SF
Official Title
Turkish Reliability and Validity of The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) in Children/Adolescents With Juvenile Idiopathic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear, Pain, Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Fear of Pain Questionnaire for Children Short Form
Intervention Description
administering the questionnaire twice, one week apart.
Primary Outcome Measure Information:
Title
Fear of Pain Questionnaire for Children Short Form
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Description
Total score ranging from 0-100. High scores mean high quality of life.
Time Frame
15 minutes
Title
Juvenile Arthritis Disease Activity Score
Description
Total JADAS score ranging from 0-57. Higher score indicates more disease activity.
Time Frame
10 minutes
Title
Childhood Health Assessment Questionnaire
Description
It consists of 8 subtests and 30 questions. It is scored between 0-3. A higher score indicates more disability.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Turkish Reliability and Validity of FOPQC-SF
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