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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine; Chronic Headache; Tension Type Headache
• Intervention / Treatment: Behavioral: Experimental: Relaxation training with VR; Behavioral: Experimental: Relaxation training without VR; Behavioral: No Intervention: Control group

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Romane Michaux, PhD Student; Phone Number: +32 471 61 03 28; Email: romane.michaux@uliege.be
• Study Contact Backup: Name: Céline Stassart, PhD; Email: cstassart@uliege.be

Study Locations

• Belgium
  • Liege
    • Sart-Tilman, Liege, Belgium, 4031
      • Recruiting
      • University of Liege
      • Contact: Romane Michaux, PhD Student; Phone Number: 0471610328; Email: romane.michaux@uliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relaxation training with VR; Psychoeducation sessions Relaxation training using biofeedback and Virtual Reality	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.
Active Comparator: Relaxation training without VR; Psychoeducation sessions Relaxation training using biofeedback	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.
Active Comparator: Control group; Psychoeducation sessions	Behavioral: No Intervention: Control group; This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain representations	Children's pain perception is assessed using the Pain Perceptions Questionnaire for Young People (PPQ-YP). This questionnaire includes four sections: Cognitive representation, which evaluates beliefs regarding the consequences of pain, perceived control, illness coherence, and recurrence (scores range from 0 to 100); Emotional representation, which assesses both responsive and anticipatory emotions related to pain, with scores ranging from 0 to 100 for frequency and intensity; Identity, which measures the frequency of symptoms associated with the pain condition and its treatment (scores range from 0 to 15); and Perceived causes of pain. Higher scores on the subscales of consequences, illness coherence, and recurrence reflect stronger beliefs about the negative impact of the pain condition, a clearer understanding of the condition, and the perception of a cyclical and recurrent nature. Conversely, higher scores on the control dimension indicate a greater sense of perceived control.	T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Pain catastrophization	Pain catastrophization is measured using the Pain Catastrophizing Scale for Children (PSC-C), which evaluates various thoughts and emotions children may have when experiencing pain. The scale consists of three subscales: rumination, amplification, and helplessness. It includes 13 items rated on a 5-point Likert-type scale. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.	T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Functional disability	Functional disability is assessed using the Child Activity Limitation Interview (CALI-21), a 21-item instrument with 5-point Likert scales. Total scores range from 0 to 52, with higher scores indicating greater limitations.	T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The quality of life is assessed using the "Inventaire Systémique de Qualité de Vie pour Enfants" (ISQVE). This scale evaluates the quality of life of children across 20 different life domains: sleep, diet, physical pain, health, clothing, physical appearance, bedroom, relationships with grandparents, relationship with mother, relationship with father, relationships with siblings, contact with friends, how my friends talk about me, school, academic performance, sports or physical activities practiced, non-sport extracurricular activities, autonomy, obedience to authority, tolerance to frustration. The scale measures where the child perceives themselves, where they set their objective, and the gap between these two.	T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Migraine Disorders; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: BE7072024000055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No