Headache in Juvenile Onset Systemic Lupus Erythematosus

NCT06658457 | Completed

• 1 other identifier: Headache
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache; Juvenile Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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).

  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'.

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

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 24, 2024
• Primary Completion: December 24, 2024
• Study Completion: December 30, 2024
• Last Updated: April 27, 2025

Record last verified: 2024-12

Locations

TU (1)