NCT05436353

Brief Summary

The Conceptualization of Pain Questionnaire (COPAQ), has been presented to the literature in order to evaluate the concept of pain in children and its psychometric properties. This scale, which was developed by Salvat et al., is stated as a tool that consists of a total of 15 items and is easy to administer and respond to. The total score is calculated with the correct or incorrect answers given by the children to these items, and the higher this score, the better the child's understanding of the concept of pain. Moreover; it has been shown that the scale has good fit and internal consistency. In Turkey, there is no valid and reliable scale to evaluate the concept of pain in a child with chronic pain. The aim of this study is to create the Turkish version of "The Conceptualization of Pain Questionnaire (COPAQ)", which evaluates the concept of pain in children with chronic pain, and to question the Turkish validity and reliability of this scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

July 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

June 23, 2022

Last Update Submit

February 13, 2024

Conditions

Keywords

painchronic painattitudes and beliefschildren

Outcome Measures

Primary Outcomes (3)

  • The Turkish version of Conceptualization of Pain Questionnaire (COPAQ-TR

    COPAQ-TR consist of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided. A score of 0 is given to incorrect responses and those marked as undecided; the sum of all the correct answers gives the total score. The higher the score, the better the participant understands the concept of pain.

    10 minutes

  • Turkish version ofPediatric Quality of Life Scale (PedsQL-TR)

    The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18.

    10 minutes

  • Turkish version of Child Health Assessment Scale (CHAQ-TR)

    CHAQ he Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities.This 30-item questionnaire is thought to have advantages over other measures of physical function due to such aspects as its multidimensionality (it assesses 8 domains of physical function).

    10 minutes

Interventions

Contact with developers and formation of steering committee Translation from English to Turkish Back translation from Turkish to English Comparison of translation Review of translated versions. Reaching consensus and development of pilot version Testing in clinical setting Revision of pilot version Testing of final version

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Participants who refferred to Pamukkale University Rheumatology Clinic will be examined by one of the researchers (specialist in rheumatology) for inclusion and exclusion criteria.

You may qualify if:

  • Diagnosed with FMF (Familial Mediterranean Fever) according to the "Tel Hashomer" diagnostic criteria
  • Speak Turkish
  • Willing to participate

You may not qualify if:

  • The presence of another systemic disease.
  • Intraarticular steroid injection or surgery in any joint in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University Hospitals

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainPainBehavior

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bilge Başakçı ÇALIK, Prof.

    Pamukkale University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 29, 2022

Study Start

July 4, 2022

Primary Completion

May 15, 2023

Study Completion

February 1, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations