NCT05436301

Brief Summary

Perception of chronic pain and related disability; occurs through the interaction of physiological and psychological processes. Pain catastrophizing is a cognitive attribution style characterized by a negative mindset and magnification of pain. Catastrophizing in children has been associated with poor functioning and higher levels of pain. Catastrophizing during the transition to adulthood is defined as an important predictor of persistent pain and central sensitivity. The number of scales assessing pain and attitudes related to pain in children is quite low. In recent years, with the adaptation of the assessment scales used for adults to children or the development of new scales, the assessment of pain and pain-related attitudes in children has begun to be provided. Pain catastrophizing scale (PCS), in 1995 Sullivan et al. for the purpose of comprehensive assessment in adults experiencing pain-related disasters. In 2003, Crombez et al. showed the validity and reliability of the scale in school-age children. For predictive validity, the scale was administered to children with chronic pain, and it was reported to predict the severity of pain and pain-related disability. Pain Catastrophizing Scale-Child (PCS-C) scale; It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 13 items rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true". Substances; rumination (4 items, e.g. "When \[my child\] has pain, I can't get him out of my mind"), magnification (3 items, e.g. the child has pain\], thinking about other painful events"), and helplessness (6 items, e.g. "\[My child's\]\] When I have pain, I feel that I cannot continue"). Items are aggregated across subscales to obtain a total score ranging from 0 to 52; higher scores are related to higher catastrophizing attitude. The pain catastrophizing scale was originally developed in German and later validity and reliability studies were conducted in different languages. The aim of this study is to question the Turkish validity and reliability of the "Pain Catastrophizing Scale-Child (PCS-C)" scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

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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
4 months until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

June 23, 2022

Last Update Submit

March 11, 2024

Conditions

Keywords

Chronic painJuvenile Idiopathic ArthritisPain Catastrophizing

Outcome Measures

Primary Outcomes (1)

  • Pain Catastrophizing Scale-Child (PCS-C)

    Pain Catastrophizing Scale-Child (PCS-C); It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 13 items rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true". Substances; rumination (4 items, e.g. "When \[my child\] has pain, I can't get him out of my mind"), magnification (3 items, e.g. the child has pain\], thinking about other painful events"), and helplessness (6 items, e.g. "\[My child's\]\] When I have pain, I feel that I cannot continue"). Items are aggregated across subscales to obtain a total score ranging from 0 to 52; higher scores are associated with higher catastrophizing attitude.

    12 months

Interventions

Personal and disease-related inquiries of the participants will be recorded in the demographic registration form. To assess the validity of the "Pain Catastrophizing Scale-Child (PCS-C)" scale, the Pediatric Quality of Life Questionnaire (PEDSQL) 3.0 Arthritis Module, Childhood Health Assessment Questionnaire (CHAQ), and Juvenile Idiopathic Arthritis Disease Activity Score (JADAS) will be administered to the participants. In this way, the consistency of the developed scale with similar questionnaires that were previously reported to be valid will be examined. In order to determine the reliability of the "Pain Catastrophizing Scale-Child (PCS-C)" scale, test-retest will be performed at one week intervals for the participants whose treatment has not undergone any change. The consistency of the scale will be determined by the data of the participants who have the first and second scale scores. Interviews will be conducted by face-to-face method.

Also known as: Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, Childhood Health Assessment Scale (CHAQ), Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Juvenile Idiopathic Arthritis (JIA); It is the most common chronic rheumatic disease in childhood. It is a chronic autoimmune disease of unknown cause, in which arthritis occurs in one and/or more joints for at least 6 weeks before the age of 16. The average prevalence values found in studies conducted in various countries are between 16-150/100.000. In the study on the prevalence of JIA in our country, the rate was; It is stated as 64/100,000. Persistent pain is the most common and bothersome symptom of JIA, and pain in childhood arthritis is multifactorial.

You may qualify if:

  • years old
  • Agree to participate in the study
  • Whose symptoms and medications are stable,
  • Do not have a psychiatric disease that may affect cooperation,
  • Patients with JIA who do not have heart failure and lung pathology at a level that will affect their daily living activities will be included.

You may not qualify if:

  • Participants who cannot understand and follow the instructions will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale university

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainArthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bilge Başakçı-Çalık, Prof

    Prof.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator PhD PT

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 29, 2022

Study Start

October 15, 2022

Primary Completion

June 15, 2023

Study Completion

January 15, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations