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NCT06921109Recruiting

Assessment of the Effectiveness of Virtual Reality as a Learning Tool for Relaxation Techniques in Reducing Pediatric Migraines and Tension Type Headache

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this interventional study is to assess the efficacy of a therapeutic intervention aimed at diminishing pediatric chronic headache. This intervention is based on the development of relaxation skills, particularly the practice of deep breathing, using virtual reality in conjunction with a biofeedback device. Specifically, it aims to assess the relevance of this tool both in learning relaxation techniques and in changing cognitions involved in pain adjustment, such as self-efficacy and pain catastrophizing. The main hypothesis is that the intervention using virtual reality will lead to greater daily use of the relaxation techniques learned, as well as an increase in the associated self-efficacy, resulting in a reduction in headaches (in terms of frequency and intensity) both immediately after the intervention and two months later. A secondary hypothesis is that this intervention will contribute to a decrease in negative pain perceptions, pain catastrophizing, and functional disability. A tertiary hypothesis is that the intervention will lead to an improvement in the child's quality of life. The effects of this intervention will be compared to those of a similar intervention without the use of virtual reality, as well as to a control condition in which only psychoeducation is provided.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
17 Jan 2025
Start date
13 Dec 2024
Primary completion date
31 Dec 2027
Lead sponsor
University of Liege
Diseases
Migraine
NCT number
NCT06921109

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 13 Dec 2024 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • having an epilepsy disorder

Who the study is looking for

  • Having a history of headaches for at least 6 months, or having been diagnosed with migraines and/or chronic tension-type headaches according to the criteria of the International Headache Society (IHS) by a pediatric neurologist.

Age in the registry: 8 years to 15 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Liege
Coordinator of this site? Confirm its status
Sart TilmanBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.