Chronic HeadacheNCT06921109
Assessment of the Effectiveness of Virtual Reality as a Learning Tool for Relaxation Techniques in Reducing Pediatric Migraines and Tension Type Headache
A study testing Experimental: Relaxation training with VR and Experimental: Relaxation training without VR in people with Chronic Headache and Migraine, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Chronic Headache, Migraine, Tension Type Headache
- What is being tested?
- Experimental: Relaxation training with VR and Experimental: Relaxation training without VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- having an epilepsy disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Céline Stassart, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University of Liege
Sart Tilman, Liege, 4031
Romane Michaux, PhD Student, 0471610328, romane.michaux@uliege.be
About this study
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.
Read more
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
- Being tested
- Experimental: Relaxation training with VR, Experimental: Relaxation training without VR, No Intervention: Control group
- Keywords
- Virtual Reality
- Medical subject headings
- Headache Disorders, Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Relaxation training with VRBehavioural
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 VRBehavioural
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 groupBehavioural
This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation training with VR | Experimental | Psychoeducation sessions Relaxation training using biofeedback and Virtual Reality Receives: Behavioral: Experimental: Relaxation training with VR |
| Relaxation training without VR | Active comparator | Psychoeducation sessions Relaxation training using biofeedback Receives: Behavioral: Experimental: Relaxation training without VR |
| Control group | Active comparator | Psychoeducation sessions Receives: Behavioral: No Intervention: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of headaches
The frequency of headaches is assessed using a sociodemographic questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start13 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAUX Romane, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921109
- Sponsor's protocol ID
- BE7072024000055
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Virtual Reality as a Learning Tool for Relaxation Techniques in Reducing Pediatric Migraines and Tension Type Headache
- ClinicalTrials.gov ID
- NCT06921109
- Acronym / sponsor ID
- BE7072024000055
- Conditions
- Chronic Headache, Migraine, Tension Type Headache
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Relaxation training with VR | Experimental | Behavioral: Experimental: Relaxation training with VRPsychoeducation sessions Relaxation training using biofeedback and Virtual Reality |
| Relaxation training without VR | Active comparator | Behavioral: Experimental: Relaxation training without VRPsychoeducation sessions Relaxation training using biofeedback |
| Control group | Active comparator | Behavioral: No Intervention: Control groupPsychoeducation sessions |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- having an epilepsy disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Relaxation training with VRThis 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. | Behavioural | Relaxation training with VR |
| Experimental: Relaxation training without VRThis 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. | Behavioural | Relaxation training without VR |
| No Intervention: Control groupThis group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes. | Behavioural | Control group |
Primary outcome
Frequency of headaches
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
The frequency of headaches is assessed using a sociodemographic questionnaire.
Intensity of headaches
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
The intensity of headaches is assessed using a sociodemographic questionnaire, measured on a Visual Analogue Scale (VAS) ranging from 0 to 10.
Self-efficacy
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
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.
Coping strategies for pain management
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
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.
Daily diary
Time frame: During the 8-week intervention (for all three groups) and during the 2 months following the intervention (only for the intervention groups).
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.
Intervention satisfaction
Time frame: T1 (Right after the 8-weeks intervention for the experimental groups)
A customized satisfaction questionnaire regarding the intervention.
Sense of presence questionnaire
Time frame: 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group
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.
Change in simulator sickness questionnaire
Time frame: Before and 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group
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.
3 secondary outcomes
Pain representations
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Pain catastrophization
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Functional disability
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Céline Stassart, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Relaxation training with VR and Experimental: Relaxation training without VR in people with Chronic Headache and Migraine, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romane Michaux, PhD Student (+32 471 61 03 28, romane.michaux@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of headaches (time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.