Clinical trial NCT06921109: Assessment of the Effectiveness of Virtual Reality as a Learning Tool for Relaxation Techniques in Reducing Pediatric Migraines and Tension Type Headache
Official title: Assessment of the Effectiveness of Virtual Reality as a Learning Tool for Relaxation Techniques in Reducing Pediatric Migraines and Tension Type Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Headache
Migraine
Tension Type Headache
Keywords: Virtual Reality
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Frequency of headaches
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
measure: Intensity of headaches
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
measure: Self-efficacy
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
measure: Coping strategies for pain management
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
measure: Daily diary
timeFrame: During the 8-week intervention (for all three groups) and during the 2 months following the intervention (only for the intervention groups).
measure: Intervention satisfaction
timeFrame: T1 (Right after the 8-weeks intervention for the experimental groups)
measure: Sense of presence questionnaire
timeFrame: 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group
measure: Change in simulator sickness questionnaire
timeFrame: Before and 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group
Secondary outcomes:
measure: Pain representations
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
measure: Pain catastrophization
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
measure: Functional disability
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Other outcomes:
measure: Quality of Life
timeFrame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Locations:
city: Sart-Tilman
country: Belgium
facility: University of Liege
state: Liege
Study officials:
References: