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

NCT06921109 | Recruiting

• 1 other identifier: BE7072024000055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Headache; Migraine; Tension Type Headache

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (8)

• Frequency of headaches

  The frequency of headaches is assessed using a sociodemographic questionnaire.

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

• Intensity of headaches

  The intensity of headaches is assessed using a sociodemographic questionnaire, measured on a Visual Analogue Scale (VAS) ranging from 0 to 10.

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

• Self-efficacy

  The child's self-efficacy related to functioning while in pain is measured using the Pediatric Rating of Chronic Illness Self-Efficacy (PRCISE). This self-report tool consists of 15 items rated on a Likert-type scale ranging from 0 ("Not at all sure") to 10 ("Very sure"). Higher scores indicate greater self-efficacy.

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

• Coping strategies for pain management

  The coping strategies used for pain management are assessed using the KidCope questionnaire. This questionnaire evaluates the coping strategies used to address major health concerns that have affected the child over the past month (distraction, social withdrawal, cognitive restructuring, self-criticism, blaming others, problem solving, emotional regulation, wishful thinking, social support, and resignation). There exists two versions of the questionnaire. The first is designed for children aged 7 to 12 years and consists of 15 items. The second is tailored for adolescents aged 13 to 18 years and includes 10 items. In both versions, participants indicate whether they use each strategy and whether it helps them manage their pain. Scores are calculated for three subscales: positive coping, avoidant coping and negative coping. A higher score indicates a greater tendency to use the assessed coping approach.

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

• Daily diary

  A daily diary assessing the occurence of headaches (frequency and intensity) and the use of coping strategies (frequency and perceived usefulness). This requires the child to document their experiences on a daily basis.

  During the 8-week intervention (for all three groups) and during the 2 months following the intervention (only for the intervention groups).

• Intervention satisfaction

  A customized satisfaction questionnaire regarding the intervention.

  T1 (Right after the 8-weeks intervention for the experimental groups)

• Sense of presence questionnaire

  This questionnaire assesses the sense of presence experienced during the VR immersion. It consists of 16 items, each rated on a Likert-type scale ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"). Scores range from 0 to 64, with higher scores indicating a stronger sense of presence.

  5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group

• Change in simulator sickness questionnaire

  Change in simulator sickness using the Simulator Sickness Questionnaire (SSQ) which is an instrument used to measure the extent to which children feel simulator sickness due to their immersion in VR (e.g., nausea, eye fatigue, dizziness, etc.). This questionnaire consists of 10 items rated on a Likert-type scale from 0 ("No") to 2 ("A lot"). Scores range from 0 to 20, with higher scores indicating a greater presence of simulator sickness symptoms.

  Before and 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group

Secondary Outcomes (3)

• Pain representations

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

• Pain catastrophization

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

• Functional disability

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

Other Outcomes (1)

• Quality of Life

  T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

Study Arms (3)

Relaxation training with VR

EXPERIMENTAL

Psychoeducation sessions Relaxation training using biofeedback and Virtual Reality

Behavioral: Experimental: Relaxation training with VR

Relaxation training without VR

ACTIVE COMPARATOR

Psychoeducation sessions Relaxation training using biofeedback

Behavioral: Experimental: Relaxation training without VR

Control group

ACTIVE COMPARATOR

Psychoeducation sessions

Behavioral: No Intervention: Control group

Interventions

Experimental: Relaxation training with VR BEHAVIORAL

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 with VR

Experimental: Relaxation training without VR BEHAVIORAL

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.

Relaxation training without VR

No Intervention: Control group BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• having an epilepsy disorder

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University of Liege

Sart Tilman, Liege, 4031, Belgium

RECRUITING

MeSH Terms

Conditions

Headache Disorders; Migraine Disorders; Tension-Type Headache

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary

Central Study Contacts

Romane Michaux, PhD Student

CONTACT

+32 471 61 03 28; romane.michaux@uliege.be

Céline Stassart, PhD

CONTACT

cstassart@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: April 10, 2025
• Study Start: December 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

BE (1)