An interventional study of Experimental: Relaxation training with VR and Experimental: Relaxation training without VR in Chronic Headache, Migraine and Tension Type Headache, sponsored by University of Liege. Recruiting at 1 site in Belgium. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by University of Liege · Not applicable, Interventional, and Treatment
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.
145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 98 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →University of Liege is the lead sponsor of 251 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Psychoeducation sessions Relaxation training using biofeedback and Virtual Reality
Behavioral: Experimental: Relaxation training with VR
Psychoeducation sessions Relaxation training using biofeedback
Behavioral: Experimental: Relaxation training without VR
Psychoeducation sessions
Behavioral: No Intervention: Control group
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.
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.
This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.
Frequency of headaches
The frequency of headaches is assessed using a sociodemographic questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before and 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group
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.
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
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.
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
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.
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
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.
Time frame: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)
Started Dec 2024 (actual). Primary completion is estimated for Dec 2027, 36 months after the start.
Of 41 non-industry interventional studies with no phase under Headache Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 42. This study's planned 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 20 months; a quarter within 7 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.