HeadacheNCT06658457
Headache in Juvenile Onset Systemic Lupus Erythematosus
An observational study of Headache and Juvenile Systemic Lupus Erythematosus, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Headache, Juvenile Systemic Lupus Erythematosus
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 30 Dec 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Headache, Juvenile Systemic Lupus Erythematosus
- Medical subject headings
- Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Melzack Pain Questionnaire
McGill Melzack Pain Questionnaire consists of four sections. The total score is between 0 and 78 As the score increases, the pain level worsens.
Measured: 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
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.
Measured: 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
It consists of 13 items. The scores range from 0 to 52. Higher score indicate that worse catastrophizing.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Fonseca Anamnestic Questionnaire
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).
Measured: 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
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'.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Oct 2024
- Primary completion24 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülal TATAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658457
- Sponsor's protocol ID
- Headache
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors That May Affect Headache in Individuals With Juvenile Onset Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06658457
- Acronym / sponsor ID
- Headache
- Conditions
- Headache, Juvenile Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Oct 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
McGill Melzack Pain Questionnaire consists of four sections. The total score is between 0 and 78 As the score increases, the pain level worsens.
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.
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.
It consists of 13 items. The scores range from 0 to 52. Higher score indicate that worse catastrophizing.
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).
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.
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'.
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 27 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Headache and Juvenile Systemic Lupus Erythematosus, run by Pamukkale 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 4 inclusion and 4 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 27 Apr 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?
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?
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.). The study lists 5 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 27 Apr 2025.