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

University of Liege

Status: Enrolling

Conditions: Chronic Headache; Migraine; Tension Type Headache

Treatments: Behavioral: No Intervention: Control group; Behavioral: Experimental: Relaxation training without VR; Behavioral: Experimental: Relaxation training with VR

Study type: Interventional

Funder types: Other

Identifiers

NCT06921109

BE7072024000055

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Relaxation training with VR

Experimental group

Description:

Psychoeducation sessions Relaxation training using biofeedback and Virtual Reality

Treatment:

Behavioral: Experimental: Relaxation training with VR

Relaxation training without VR

Active Comparator group

Description:

Psychoeducation sessions Relaxation training using biofeedback

Treatment:

Behavioral: Experimental: Relaxation training without VR

Control group

Active Comparator group

Description:

Psychoeducation sessions

Treatment:

Behavioral: No Intervention: Control group