Turkish Reliability and Validity of FOPQC-SF

September 22, 2023 updated by: Elif Gur Kabul, Pamukkale University

Turkish Reliability and Validity of The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) in Children/Adolescents With Juvenile Idiopathic Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pamukkale
      • Denizli, Pamukkale, Turkey, 20070
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Other: Fear of Pain Questionnaire for Children Short Form
administering the questionnaire twice, one week apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Pain Questionnaire for Children Short Form
Time Frame: 10 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Time Frame: 15 minutes
Total score ranging from 0-100. High scores mean high quality of life.
15 minutes
Juvenile Arthritis Disease Activity Score
Time Frame: 10 minutes
Total JADAS score ranging from 0-57. Higher score indicates more disease activity.
10 minutes
Childhood Health Assessment Questionnaire
Time Frame: 15 minutes
It consists of 8 subtests and 30 questions. It is scored between 0-3. A higher score indicates more disability.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2022

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

June 26, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOPQC-SF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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