Turkish Reliability and Validity of FOPQC-SF | NCT05439434

Studies
Turkish Reliability and Validity of FOPQC-SF

NCT05439434

Sponsor

Pamukkale University

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Fear
Pain
Juvenile Idiopathic Arthritis

Interventions

Fear of Pain Questionnaire for Children Short Form

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2022Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jun 15, 2023Actual

First Submitted Date

Jun 26, 2022

First Submission Date that Met QC Criteria

Jun 26, 2022

First Posted Date

Jun 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2023

Last Update Posted Date

Sep 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental		Other: Fear of Pain Questionnaire for Children Short Form

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fear of Pain Questionnaire for Children Short Form	Other	administering the questionnaire twice, one week apart.	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Juvenile Arthritis Disease Activity Score

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University		Denizli	Pamukkale	20070	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001171	Arthritis, Juvenile

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001168	Arthritis

Browse Leaves

Not provided

Browse Branches

Not provided