NCT06921109 Assessment of the Effectiveness of Virtual Reality as a Learning Tool for Relaxation Techniques in Reducing Pediatric Migraines and Tension Type Headache
| NCT ID | NCT06921109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Liege |
| Condition | Chronic Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * having an epilepsy disorder
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06921109 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 15 Years, studying Chronic Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921109 currently recruiting?
Yes, NCT06921109 is actively recruiting participants. Contact the research team at romane.michaux@uliege.be for enrollment information.
Where is the NCT06921109 trial being conducted?
This trial is being conducted at Sart Tilman, Belgium.
Who is sponsoring the NCT06921109 clinical trial?
NCT06921109 is sponsored by University of Liege. The trial plans to enroll 60 participants.