- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06658457
Headache in Juvenile Onset Systemic Lupus Erythematosus
April 25, 2025 updated by: Zülal TATAR, Pamukkale University
Investigation of Factors That May Affect Headache in Individuals With Juvenile Onset Systemic Lupus Erythematosus
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Denizli, Turkey
- Pamukkale University
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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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study will include individuals ages 8 to 25 years who are receiving treatment for Juvenile Onset Systemic Lupus Erythematosus at a university hospital in Turkey, and meet the inclusion and exclusion criteria.
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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McGill Melzack Pain Questionnaire
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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McGill Melzack Pain Questionnaire consists of four sections.
The total score is between 0 and 78 As the score increases, the pain level worsens.
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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
Time Frame: 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 is a revised questionnaire consisting of 13 items.
Scores range from 0 to 52.
Higher score indicate that worse catastrophizing.
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Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
|
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Pain Catastrophizing Scale for Parents
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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It consists of 13 items.
The scores range from 0 to 52.
Higher score indicate that worse catastrophizing.
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Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
|
|
Fonseca Anamnestic Questionnaire
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
|
Temporomandibular joint dysfunction was assessed using the Fonseca Anamnestic Questionnaire.
The Fonseca Anamnestic Questionnaire consists of 10 questions.
The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points) and 'Sometimes' (5 points).
The questionnaire score is scored for all questions and the severity of Temporomandibular joint dysfunction is classified according to the total score.
It is classified as no Temporomandibular joint dysfunction (0-15 points), mild Temporomandibular joint dysfunction (20-40 points), moderate Temporomandibular joint dysfunction (45-65 points), severe Temporomandibular joint dysfunction (70-100).
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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
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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Such as forehead pain, jaw pain, sore throat, ear pain, neck pain, shoulder pain, psychiatric support, parental togetherness, parents being involved in the child's life, use of vitamin supplements, history of hospitalization due to headache, previous surgery, hearing problems, recurrent sinus infection, recurrent sore throat, asthma, snoring, snoring during sleep, vomiting with headache, reflux, recurrent stomach pain, numbness and tingling with headache, easy bleeding and bruising, eating disorder, frequent nosebleeds, diabetes, obesity, sudden weight loss were recorded as 'yes/no'.
|
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 24, 2024
Primary Completion (Actual)
December 24, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
October 24, 2024
First Submitted That Met QC Criteria
October 24, 2024
First Posted (Actual)
October 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 27, 2025
Last Update Submitted That Met QC Criteria
April 25, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Headache
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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