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
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-13
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Relaxation training with VR
Psychoeducation sessions Relaxation training using biofeedback and Virtual Reality
Experimental: Relaxation training with VR
This group will benefit from 8 psychoeducation sessions delivered through video modules viewed alongside the psychologist. In addition, an intervention will be implemented to train the children in abdominal breathing and muscle relaxation. This training will be conducted using biofeedback equipment integrated into various virtual environments. Homework exercises will be assigned to them after each session.
Relaxation training without VR
Psychoeducation sessions Relaxation training using biofeedback
Experimental: Relaxation training without VR
This group will benefit from 8 psychoeducation sessions delivered through video modules viewed alongside the psychologist. In addition, an intervention will be implemented to train the children in abdominal breathing and muscle relaxation. This training will be conducted using biofeedback equipment displayed on a computer screen. Homework exercises will be assigned to them after each session.
Control group
Psychoeducation sessions
No Intervention: Control group
This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.
Interventions
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Experimental: Relaxation training with VR
This group will benefit from 8 psychoeducation sessions delivered through video modules viewed alongside the psychologist. In addition, an intervention will be implemented to train the children in abdominal breathing and muscle relaxation. This training will be conducted using biofeedback equipment integrated into various virtual environments. Homework exercises will be assigned to them after each session.
Experimental: Relaxation training without VR
This group will benefit from 8 psychoeducation sessions delivered through video modules viewed alongside the psychologist. In addition, an intervention will be implemented to train the children in abdominal breathing and muscle relaxation. This training will be conducted using biofeedback equipment displayed on a computer screen. Homework exercises will be assigned to them after each session.
No Intervention: Control group
This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
8 Years
15 Years
ALL
No
Sponsors
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University of Liege
OTHER
Responsible Party
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MICHAUX Romane
PhD Student
Locations
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University of Liege
Sart Tilman, Liege, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BE7072024000055
Identifier Type: -
Identifier Source: org_study_id
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