Juvenile Idiopathic Arthritis (JIA)NCT07185750
Investigation of Catastrophizing of Pain Reported by Parents in JIA Patients
An observational study of Juvenile Idiopathic Arthritis (JIA) and Childhood Rheumatic Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Juvenile idiopathic arthritis (JIA) is the primary rheumatic disease reported to affect the pediatric population. Research suggests that parents' thoughts and feelings about their child's pain, specifically with JIA diagnosis, may influence treatment compliance. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA), Childhood Rheumatic Diseases
- What is being tested?
- Questionnaire application for JIA cases and their parents
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 4 Aug 2027
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- Between 7-18 years of age
- Diagnosed with JIA
- Individuals who volunteer to participate in the study will be included.
Who cannot join
- Having advanced heart/lung/liver/kidney disease, neurological disease, or malignancies
- Having undergone major orthopedic surgery
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Çankaya, Ankara
Orkun Tüfekçi, PT, PhD(c), 05319502648, orkuntf@gmail.com
About this study
Official title: Investigation of Biopsychosocial Characteristics According to Catastrophizing of Pain Reported by Parents in Patients Diagnosed With JIA
Juvenile idiopathic arthritis (JIA) is the primary rheumatic disease reported to affect the pediatric population. Research suggests that parents' thoughts and feelings about their child's pain, specifically with JIA diagnosis, may influence treatment compliance. Considering that this situation may also affect children's adherence to treatment, the identification and management of parents' catastrophizing of pain is emphasized as important in improving treatment outcomes. This study aimed to examine the biopsychosocial characteristics of parents of children diagnosed with JIA according to their reported catastrophizing of pain.
- Being tested
- Questionnaire application for JIA cases and their parents
- Keywords
- Pain catastrophizing, chronic pain
- Medical subject headings
- Arthritis, Juvenile, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire application for JIA cases and their parentsOther
Scales will be applied to cases diagnosed with JIA and their parents
| Study group | Role | What they receive |
|---|---|---|
| Cases diagnosed with JIA | JIA patients and their parents who visited the rheumatology outpatient clinic of a university hospital. A questionnaire will be administered to the child cases and their parents. Receives: Other: Questionnaire application for JIA cases and their parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Scale-Parent (PCS-P)
It is assessed using a 5-point Likert scale ranging from 0 (never) to 4 (always) and consists of 13 items. Similar to the child questionnaire, it assesses 3 domains: rumination, magnification, and helplessness. A total score between 0 and 52 is obtained; higher scores reflect a higher level of catastrophizing in parents.
Measured: Baseline
Pain Catastrophizing Scale-Children (PCS-C)
Consists of 13 items that describe the different thoughts and feelings children may experience when they feel pain. The questionnaire measures three domains: rumination, magnification, and helplessness. All items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Higher scores indicate more catastrophic pain beliefs. The total score ranges from 0 to 52.
Measured: Baseline
Secondary outcomes (5)
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient
It is a patient/parent-centered measurement method that helps assess the patient's biopsychosocial aspects, such as disease activity, posture, functional and psychosocial status, fatigue, and school performance. The results from the questions are used to assess the functional status of children, while their psychosocial status is recorded based on their answers to 21 questions (ranging from 0 to 358). A high score indicates a poor psychosocial status.
Measured: Baseline
Childhood Health Assessment Questionnaire (CHAQ)
The CHAQ assesses the functional abilities of children diagnosed with rheumatic diseases in their daily living activities. It consists of eight subscales (dressing and personal care, standing up, eating, walking, body care, reaching, grasping, activities) (0-3) and also assesses pain and general well-being using a visual analog scale (0-100). A high score indicates low functionality.
Measured: Baseline
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
It consists of 74 items covering various health domains, including physical functioning, emotional well-being, and general symptoms. The items are divided into four dimensions related to the child's quality of life: gross motor function (GMF), fine motor function (FMF), psychosocial function (PF), and systemic or general symptoms (SGS). Each domain is scored on a Likert-type scale from 1 to 7; higher scores indicate poorer health-related quality of life. There is also a "not applicable to me" option for the items. The scale also includes a pain measurement (10 cm Visual Analog Scale (VAS)) to assess pain, but this score is not included in the total score.
Measured: Baseline
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family
JAB-Q is a multidimensional questionnaire and a parent (family) form. Developed in Turkish by Ünal and colleagues, the questionnaire is completed by one of the child's parents. The family form evaluates the parents' biopsychosocial status from their own perspective and provides scores ranging from 0 to 102. Higher scores indicate a worse biopsychosocial status.
Measured: Baseline
Child and Adolescent Scale of Participation (CASP)
This is a 20-question survey that evaluates the community participation of children and adolescents in school, neighborhood, and local settings. The survey is divided into four sections: 6 questions about home participation, four questions on neighborhood and community involvement, five questions regarding school participation, and five questions on home and community engagement. It is rated on a scale of "expected for their age (full participation), somewhat limited, very limited, unable to participate, and inapplicable." The survey is completed by the child's family or primary caregiver. The person filling out the questionnaire is asked to select the answer that best describes the child's level of participation. The assessment is scored out of 100 points, with higher scores reflecting a greater level of participation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start4 Aug 2025
- Primary completion4 Aug 2026 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- More trials run by Hacettepe 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
- 50 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185750
- Sponsor's protocol ID
- SBA 25/530
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biopsychosocial Characteristics According to Catastrophizing of Pain Reported by Parents in Patients Diagnosed With JIA
- ClinicalTrials.gov ID
- NCT07185750
- Acronym / sponsor ID
- SBA 25/530
- Keywords
- Pain catastrophizing, chronic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 4 Aug 2026 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 22 Sep 2025 (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.
Juvenile idiopathic arthritis (JIA) is the primary rheumatic disease reported to affect the pediatric population. Research suggests that parents' thoughts and feelings about their child's pain, specifically with JIA diagnosis, may influence treatment compliance. Considering that this situation may also affect children's adherence to treatment, the identification and management of parents' catastrophizing of pain is emphasized as important in improving treatment outcomes. This study aimed to examine the biopsychosocial characteristics of parents of children diagnosed with JIA according to their reported catastrophizing of pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases diagnosed with JIA | – | Other: Questionnaire application for JIA cases and their parentsJIA patients and their parents who visited the rheumatology outpatient clinic of a university hospital. A questionnaire will be administered to the child cases and their parents. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (3 listed)
- Between 7-18 years of age
- Diagnosed with JIA
- Individuals who volunteer to participate in the study will be included.
Key exclusion criteria (3 listed)
- Having advanced heart/lung/liver/kidney disease, neurological disease, or malignancies
- Having undergone major orthopedic surgery
- Not volunteering to participate in 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 |
|---|---|---|
| Questionnaire application for JIA cases and their parentsScales will be applied to cases diagnosed with JIA and their parents | Other | Cases diagnosed with JIA |
Primary outcome
Pain Catastrophizing Scale-Parent (PCS-P)
Time frame: Baseline
It is assessed using a 5-point Likert scale ranging from 0 (never) to 4 (always) and consists of 13 items. Similar to the child questionnaire, it assesses 3 domains: rumination, magnification, and helplessness. A total score between 0 and 52 is obtained; higher scores reflect a higher level of catastrophizing in parents.
Pain Catastrophizing Scale-Children (PCS-C)
Time frame: Baseline
Consists of 13 items that describe the different thoughts and feelings children may experience when they feel pain. The questionnaire measures three domains: rumination, magnification, and helplessness. All items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Higher scores indicate more catastrophic pain beliefs. The total score ranges from 0 to 52.
5 secondary outcomes
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient
Time frame: Baseline
Childhood Health Assessment Questionnaire (CHAQ)
Time frame: Baseline
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
Time frame: Baseline
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family
Time frame: Baseline
Child and Adolescent Scale of Participation (CASP)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Juvenile Idiopathic Arthritis (JIA) and Childhood Rheumatic Diseases, run by Hacettepe 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orkun Tüfekçi, PT, PhD(c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Catastrophizing Scale-Parent (PCS-P) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 22 Sep 2025.