Turkish Reliability and Validity of FOPQC-SF

Sponsor

Pamukkale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05439434

Collaborator

(none)

Enrollment

Location

Arm

10.8

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fear Pain Juvenile Idiopathic Arthritis	Other: Fear of Pain Questionnaire for Children Short Form	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Jul 20, 2022

Anticipated Primary Completion Date :

Jan 20, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intervention group

Other: Fear of Pain Questionnaire for Children Short Form

administering the questionnaire twice, one week apart.

Outcome Measures

Primary Outcome Measures

Fear of Pain Questionnaire for Children Short Form [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli	Pamukkale	Turkey	20070

Sponsors and Collaborators

Pamukkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elif Gur Kabul, Pirincipal Investigator, Pamukkale University

ClinicalTrials.gov Identifier:

NCT05439434

Other Study ID Numbers:

FOPQC-SF

First Posted:

Jun 30, 2022

Last Update Posted:

Jul 6, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Juvenile

Study Results

No Results Posted as of Jul 6, 2022