Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C)

March 11, 2024 updated by: Ozge Cankaya, Kutahya Health Sciences University

Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C) in Children/Adolescents With Juvenile Idiopathic Arthritis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Now, the study is continuing. 50% of the participant were evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  1. 7-18 years old
  2. Agree to participate in the study
  3. Whose symptoms and medications are stable,
  4. Do not have a psychiatric disease that may affect cooperation,
  5. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale-Child (PCS-C)
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bilge Başakçı-Çalık, Prof, Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSBU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings