Actively Recruiting

Phase Not Applicable
Age: 8Years - 15Years
All Genders
ID06921109

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

Led by University of Liege · Updated on 2025-04-10

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a behavioral intervention to reduce chronic headaches in children aged 8 to 15 years. The study aims to assess how using virtual reality combined with biofeedback can help children learn relaxation techniques like deep breathing, improve their confidence in managing pain, and reduce headache frequency and intensity. The study also compares this approach to similar relaxation training without virtual reality and to a control group receiving only psychoeducation. Participants are randomly assigned to one of three groups: relaxation training with virtual reality and biofeedback, relaxation training with biofeedback alone, or a control group receiving psychoeducation through video modules at home. The interventions last for 8 weeks with sessions including psychoeducation, relaxation training, and homework exercises to reinforce skills. Throughout the study, researchers will monitor headache frequency and intensity, self-efficacy, pain coping strategies, and satisfaction with the intervention at the start, immediately after the 8-week program, and two months later for intervention groups. Additional assessments include daily diaries during treatment, pain perceptions, functional disability, and questionnaires about the virtual reality experience. The total participation involves these assessments and follow-ups over several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 8 to 15 years
  • History of headaches for at least 6 months, or diagnosed with migraines and/or chronic tension-type headaches by a pediatric neurologist according to International Headache Society criteria
Not Eligible

You will not qualify if you...

  • Having an epilepsy disorder

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants receive 8 weekly psychoeducation sessions with relaxation training using biofeedback, with or without virtual reality depending on group assignment. Homework exercises are assigned after each session. The control group receives psychoeducation video modules at home.

Weekly visits for 8 weeks

Follow-up

Duration - 2 months

Participants in the intervention groups continue to record daily diaries and are assessed 2 months after the intervention to evaluate the lasting effects of the relaxation training.

Approximately 1 post-treatment visit and daily diary entries

Trial Site Locations

Total: 1 location

1

University of Liege

Sart Tilman, Liege, Belgium, 4031

Actively Recruiting

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Research Team

R

Romane Michaux, PhD Student

C

Céline Stassart, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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