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

NCT06921109 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-10

No results posted yet for this study

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.

Conditions

  • Chronic Headache
  • Migraine
  • Tension Type Headache

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

No Intervention: Control group

This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921109 on ClinicalTrials.gov