VR-relaxation for ECT-related Anxiety
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: VR-based relaxation, Breathing exercises, Treatment as usual.
- Кому может быть актуально
- Состояния в реестре: ECT-related Anxiety. Базовые параметры: 18 лет — 75 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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Официальное название
Effectiveness of Virtual Reality-based Relaxation on Electroconvulsive Therapy-related Anxiety
Обзор
The goal of this clinical trial is to learn if there is an effect of Virtual Reality (VR) based-relaxation on electroconvulsive therapy (ECT)-related anxiety. The main questions it aims to answer are: * Does VR based-relaxation have an effect on anxiety in patients receiving ECT as part of routine clinical care? * Does VR based-relaxation have an effect on stress symptoms and heart rate in patients receiving ECT as part of routine clinical care? * Does depression severity have an effect on the effectivity of VR-based relaxation Researchers will compare VR-relaxation to relaxation breathing exercises and no relaxation to see if VR-based relaxation has an effect on ECT-related anxiety.
Вмешательства
- Устройство VR-based relaxation
Participants will receive a relaxation session using VR-goggles prior to their ECT. The VR session includes immersive calming visuals and audio. - Другое Breathing exercises
Participants will perform a guided breathing exercises session. - Другое Treatment as usual
Participants will receive treatment as usual without any additional relaxation intervention during this condition.
Первичные конечные точки
- Change in anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU). [Срок оценки: Pre-intervention to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.]
- Change in anxiety levels (VAS-anxiety) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU). [Срок оценки: pre- to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.]
Вторичные конечные точки (3)
- Improvement in stress symptom (VAS-Stress) score after VR relaxation in comparison to breathing exercises and TAU. [Срок оценки: Pre-intervention and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.]
- Improvement in stress symptom (heart rate) score after VR relaxation in comparison to breathing exercises and TAU. [Срок оценки: Pre- and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.]
- The effect of depression severity on the effectivity of VR-based relaxation. [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Age 18-75 years
- Being treated with ECT, having had at least two sessions at study start
- Able to understand study procedure and sign informed consent
- Speaking Dutch or French
- DSM-5 diagnosis of a depressive disorder, for which ECT treatment has been initiated
Критерии исключения
\- Contra-indications for VR: photosensitive epilepsy, severe travel sickness, vertigo, open wounds on the face
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
Бельгия · 1 центр
- University Hospital Brussels — Brussels
Идентификаторы
NCT: NCT07546526 · 1432025000282