Chronic PainNCT05436301
Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C)
An observational study of Chronic Pain and Juvenile Idiopathic Arthritis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Juvenile Idiopathic Arthritis
- What is being tested?
- Pain Catastrophizing Scale
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 7-18 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.
Who cannot join
- Participants who cannot understand and follow the instructions will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Now, the study is continuing. 50% of the participant were evaluated.
- Conditions
- Chronic Pain, Juvenile Idiopathic Arthritis
- Being tested
- Pain Catastrophizing Scale
- Keywords
- Chronic pain, Juvenile Idiopathic Arthritis, Pain Catastrophizing
- Medical subject headings
- Chronic Pain, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Catastrophizing ScaleOther
Also called Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, Childhood Health Assessment Scale (CHAQ), Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Oct 2022
- Primary completion15 Jun 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Cankaya, Kutahya Health Sciences University
- Investigators
- Bilge Başakçı-Çalık, Prof, Study director, Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436301
- Sponsor's protocol ID
- KSBU
- Status last verified
- Mar 2024
- First submitted
- 23 Jun 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C) in Children/Adolescents With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05436301
- Acronym / sponsor ID
- KSBU
- Conditions
- Chronic Pain, Juvenile Idiopathic Arthritis
- Keywords
- Chronic pain, Juvenile Idiopathic Arthritis, Pain Catastrophizing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Now, the study is continuing. 50% of the participant were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 7-18 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.
Key exclusion criteria (1 listed)
- Participants who cannot understand and follow the instructions will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Catastrophizing ScaleAlso: Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, Childhood Health Assessment Scale (CHAQ), Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilge Başakçı-Çalık, Prof study director
Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Juvenile Idiopathic Arthritis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Catastrophizing Scale-Child (PCS-C) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.