NCT05414513

Brief Summary

Children's chronic pain is a significant condition that affects roughly 25% of children, with approximately 3% of them requiring intense pain therapy. In the adult literature, various scales have been established to assess fear of pain. When these scales are studied, fear of pain has been shown to have a role in adult chronic pain research, but this topic has gotten less attention in pediatric chronic pain research. The Fear of Pain Questionnaire for Children (FOPQ-C) is a questionnaire that addresses this knowledge gap. The purpose of this study is to determine the validity and clinical utility of the Fear of Pain Questionnaire for Children (FOPQ-C) Scale in the Turkish community.

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
195

participants targeted

Target at P50-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
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 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

Chronic Headache

Keywords

Chronic headachePain related fearAssessmentChildrenvaliditycultural adaptation

Outcome Measures

Primary Outcomes (2)

  • Evaluation of pain of fear for children

    The Fear of Pain Questionnaire-Short Form (FOPQ-C-SF) for Children is a 10-item variant of the 24-item Fear of Pain Questionnaire for Children. It uses children's self-reports to assess pain-related anxieties (4 items) and avoidance behaviors (6 items). When I'm in pain, for example, I cancel my plans. When I'm in pain, I'm worried something bad may happen. A 0-4 Likert scale is used for scoring. A score of 0 indicates significant disagreement, while a score of 5 indicates great agreement. The total score is calculated by aggregating the individual item scores. Higher pain-related fear and avoidance behavior are associated with higher scores.

    Baseline

  • Evaluation of pain of fear for parents

    The Fear of Pain Scale for Children-Parent Form (FOPQ-P) is a scale that evaluates children's fear of pain with a parent report. FOPQ-P consists of 23 items. The scale assesses fear of pain in three sub-areas. These are: Fear of Pain (8 items), Avoidance of Activities (10 items), and Avoidance of School (5 items). Scoring is done on a Likert scale of 0-4 points. The parent rates the child's approach to pain that has existed for several hours or throughout the day, from 0 = strongly disagree to 4 = strongly agree.

    Baseline

Secondary Outcomes (2)

  • Evaluation of pain catastrophing for children

    Baseline

  • Evaluation of pain for children

    Baseline

Study Arms (2)

Chronic Headache Group

Children with chronic headache

Healthy Group

Children without pain

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with chronic pain at aged 5-18 years and their parents, their health peers without chronic pain and their parents

You may qualify if:

  • (1) Being diagnosed with chronic pain. (2) To have the cognitive ability to answer questions for assessment. (3) Completing the test-retest assessment. (4) To be the native language Turkish.

You may not qualify if:

  • Uncontrollable psychological diseases (eg, attention deficit hyperactivity disorder, autism spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder), specific pathologies, will not be included in the study.
  • Patients who started a new treatment during the study or 6 weeks before the study.
  • Study participants will be instructed not to take analgesics for 48 hours prior to assessments.
  • between the ages of 5-18.
  • Not having any psychiatric or neurological diagnosis.
  • To be the native language Turkish.
  • Families and children who did not agree to participate in the study.
  • To have received medical treatment for any neuropsychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

RECRUITING

Related Publications (8)

  • Palermo TM, Chambers CT. Parent and family factors in pediatric chronic pain and disability: an integrative approach. Pain. 2005 Dec 15;119(1-3):1-4. doi: 10.1016/j.pain.2005.10.027. Epub 2005 Nov 18. No abstract available.

    PMID: 16298492RESULT

  • Palermo TM. Impact of recurrent and chronic pain on child and family daily functioning: a critical review of the literature. J Dev Behav Pediatr. 2000 Feb;21(1):58-69. doi: 10.1097/00004703-200002000-00011.

    PMID: 10706352RESULT

  • King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.

    PMID: 22078064RESULT

  • Jiao J, Vincent A, Cha SS, Luedtke CA, Kim CH, Oh TH. Physical Trauma and Infection as Precipitating Factors in Patients with Fibromyalgia. Am J Phys Med Rehabil. 2015 Dec;94(12):1075-82. doi: 10.1097/PHM.0000000000000300.

    PMID: 25888651RESULT

  • Hechler T, Dobe M, Zernikow B. Commentary: A worldwide call for multimodal inpatient treatment for children and adolescents suffering from chronic pain and pain-related disability. J Pediatr Psychol. 2010 Mar;35(2):138-40. doi: 10.1093/jpepsy/jsp066. Epub 2009 Aug 14. No abstract available.

    PMID: 19684118RESULT

  • Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.

    PMID: 17180640RESULT

  • Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.

    PMID: 10781906RESULT

  • Berniger Romariz JA, Nonnemacher C, Abreu M, Dickel Segabinazi J, Bandeira JS, Beltran G, Souza A, Torres IL, Caumo W. The Fear of Pain Questionnaire: psychometric properties of a Brazilian version for adolescents and its relationship with brain-derived neurotrophic factor (BDNF). J Pain Res. 2019 Aug 7;12:2487-2502. doi: 10.2147/JPR.S199120. eCollection 2019.

    PMID: 31496790RESULT

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ozgun Kaya Kara, Assoc. Prof

    Akdeniz University

    STUDY DIRECTOR

Central Study Contacts

Ishak Isik, MD

CONTACT

02422494400etik.kurul.07@gmail.com

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 10, 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 results are going to publish the journal

Locations

TU(1)