Идёт набор NCT06921109

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

Без фазы С лечением Chronic Headache Migraine Tension Type Headache

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Experimental: Relaxation training with VR, Experimental: Relaxation training without VR, No Intervention: Control group.
Кому может быть актуально: Состояния в реестре: Chronic Headache, Migraine, Tension Type Headache. Базовые параметры: 8 лет — 15 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Поведенческое 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.
Поведенческое 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.
Поведенческое No Intervention: Control group
This group will benefit from 8 psychoeducation sessions delivered through video modules sent to their homes.

Первичные конечные точки

Frequency of headaches [Срок оценки: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)]
Intensity of headaches [Срок оценки: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)]
Self-efficacy [Срок оценки: 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 [Срок оценки: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)]
Daily diary [Срок оценки: During the 8-week intervention (for all three groups) and during the 2 months following the intervention (only for the intervention groups).]
Intervention satisfaction [Срок оценки: T1 (Right after the 8-weeks intervention for the experimental groups)]
Sense of presence questionnaire [Срок оценки: 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 [Срок оценки: Before and 5 minutes after the use of virtual reality during each of the 8 sessions of the virtual reality interventional group]

Вторичные конечные точки (3)

Pain representations [Срок оценки: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)]
Pain catastrophization [Срок оценки: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)]
Functional disability [Срок оценки: T0 (Before the intervention), T1 (Right after the 8-weeks intervention), and T2 (2 months post-intervention for interventional groups only)]

Критерии участия

Критерии включения

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.