CompletedNot Applicable

Headache in Juvenile Onset Systemic Lupus Erythematosus

Turkey (Türkiye)15 participantsStarted 2024-10-24

Plain-language summary

The aim of our study was to compare individuals with juvenile onset systemic lupus erythematosus with and without headache in terms of pain, pain catastrophizing behavior, demographic and individual disease-related factors that may affect headache and temporomandibular joint dysfunction.

Who can participate

Age range

8 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Having been diagnosed with Juvenile Onset Systemic Lupus Erythematosus by the Pediatric Rheumatology Clinic * Being between the ages of 8-25, * Having stable symptoms and medications * Being willing to participate in the study Exclusion Criteria: * Patients with neuropsychiatric disorders not associated with Juvenile Onset Systemic Lupus Erythematosus (such as history of epilepsy, electrolyte imbalance, or medication side effects) * History of headache before juvenile onset systemic lupus erythematosus diagnosis * Presence of another concomitant rheumatic disease * Having cognitive impairment to the extent of not being able to cooperate

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

McGill Melzack Pain Questionnaire

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Pain Catastrophizing Scale for Children

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Pain Catastrophizing Scale for Parents

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Fonseca Anamnestic Questionnaire

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Demographic and disease-related data

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Trial details

NCT IDNCT06658457

SponsorPamukkale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-24

View on ClinicalTrials.gov More Headache trials

Who can participate

Age range

8 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

McGill Melzack Pain Questionnaire

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Pain Catastrophizing Scale for Children

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Pain Catastrophizing Scale for Parents

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Fonseca Anamnestic Questionnaire

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Demographic and disease-related data

Timeframe: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.