NCT05439434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

June 26, 2022

Last Update Submit

September 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module

    15 minutes

  • Juvenile Arthritis Disease Activity Score

    10 minutes

  • Childhood Health Assessment Questionnaire

    15 minutes

Study Arms (1)

intervention group

EXPERIMENTAL
Other: Fear of Pain Questionnaire for Children Short Form

Interventions

administering the questionnaire twice, one week apart.

intervention group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being diagnosed with JIA according to the ILAR classification
  • years old
  • Agree to participate in the study

You may not qualify if:

  • Psychiatric illness that may affect cooperation,
  • Those with heart failure and lung pathology at a level that will affect their daily life activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainArthritis, Juvenile

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pirincipal Investigator

Study Record Dates

First Submitted

June 26, 2022

First Posted

June 30, 2022

Study Start

November 20, 2022

Primary Completion

January 20, 2023

Study Completion

June 15, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations