NCT05422443

Brief Summary

Biological, psychological, and social factors all influence a child's sense of pain. Pain beliefs can have a significant impact on a person's perception of pain and adherence to treatment. As a result, pain management requires a thorough examination of the factors that influence pain perception. Coping is a cognitive and behavioral response to conditions and threats based on by personal or environmental factors. Children who do not have adequate coping mechanisms suffer from more severe pain. As a result, dealing with pain is a crucial part of pain management. This highlights the need of assessing pain coping in children when treating chronic pain. The purpose of this study is to show that the Turkish version of the Pain Coping Questionnaire (PCQ), which assesses children's pain coping techniques, is valid and reliable, as well as to ensure that it is culturally appropriate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 8, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

June 8, 2022

Last Update Submit

May 31, 2023

Conditions

Keywords

painchildrencoping

Outcome Measures

Primary Outcomes (2)

  • Evaluation of coping strategies

    Pain Coping Questionnaire: Evaluates the coping strategies of children and adolescents with a total of 39 items in 8 subscale. These are seeking knowledge, problem solving, seeking social support, positive self-suggestion, behavioral distraction, cognitive distraction, externalization, and internalization/catastrophizing. Items are assessed on a 5-point Likert scale, with 1 indicating never and 5 indicating very often. Higher ratings indicate higher use of coping strategy. PCQ consists of parent and adolescent form.

    Baseline

  • Evaluation of pain

    Wong baker faces pain scale: It is a valid and reliable scale preferred by children and their families to evaluate the severity of pain. It consists of 6 facial expressions that symbolize the severity of pain. These show the stages of increased pain from a smiling face (0 points) to a very sad and crying face (10 points). The meaning of each facial expression is carefully explained to the child. Children rate pain intensity according to face shapes.

    Baseline

Secondary Outcomes (1)

  • Evaluation of pain acceptance

    Baseline

Study Arms (2)

Chronic pain group

Children with chronic pain

Health group

children without chronic pain

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children are diagnosed with chronic pain and their parents Children without chronic pain and their parents

You may qualify if:

  • Age between 6 years and 18 years;
  • Diagnosed with chronic pain.
  • To have the cognitive ability to answer questions for assessment.
  • Completing the test-retest assessment.
  • To be able to read and speak Turkish

You may not qualify if:

  • Patients with unmanageable psychological disorders (e.g., attention deficit hyperactivity disorder, autistic spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.
  • Patients who started a new treatment during the trial or 6 weeks before to the study for chronic pain.
  • Those who take analgesics 48 hours prior to study evaluations
  • Healthy children aged 6-18 years old
  • Children without a psychiatric and neurological diagnosis
  • Children got medical treatment for a neuropsychiatric disorder
  • Children whose parents or themselves refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (6)

  • Liossi C, Howard RF. Pediatric Chronic Pain: Biopsychosocial Assessment and Formulation. Pediatrics. 2016 Nov;138(5):e20160331. doi: 10.1542/peds.2016-0331. Epub 2016 Oct 14.

  • Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.

  • Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.

  • Fraga MM, Terreri MT, Azevedo RT, Hilario MOE, Len CA. PAIN PERCEPTION AND PAIN COPING MECHANISMS IN CHILDREN AND ADOLESCENTS WITH JUVENILE FIBROMYALGIA AND POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS. Rev Paul Pediatr. 2019 Jan-Mar;37(1):11-19. doi: 10.1590/1984-0462/;2019;37;1;00006. Epub 2018 Jun 11.

  • Failo A, Beals-Erickson SE, Venuti P. Coping strategies and emotional well-being in children with disease-related pain. J Child Health Care. 2018 Mar;22(1):84-96. doi: 10.1177/1367493517749326. Epub 2017 Dec 19.

  • Hermann C, Hohmeister J, Zohsel K, Ebinger F, Flor H. The assessment of pain coping and pain-related cognitions in children and adolescents: current methods and further development. J Pain. 2007 Oct;8(10):802-13. doi: 10.1016/j.jpain.2007.05.010. Epub 2007 Jul 12.

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ozgun Kaya Kara, Assoc. Prof.

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PhD

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 16, 2022

Study Start

September 8, 2022

Primary Completion

August 8, 2023

Study Completion

August 12, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The study result will be published to the journal

Locations