Recovery With Virtual Reality for Stress and Pain
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: Preoperative Virtual Reality, Usual Perioperative Care.
- Кому может быть актуально
- Состояния в реестре: Preoperative Anxiety, Postoperative Pain, Postoperative Recovery. Базовые параметры: от 18 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Recovery With Virtual Reality for Stress & Pain (ReVRS)
Обзор
This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Approximately 140 participants will be randomly assigned in a 1:1 ratio to either virtual reality in addition to usual care or usual care alone. The virtual reality intervention will consist of approximately 10-20 minutes of an immersive relaxation experience before surgery. The primary outcome is the change in preoperative anxiety measured before and after the intervention. Secondary outcomes include postoperative quality of recovery, pain, opioid consumption, postoperative nausea and vomiting, and early recovery-related healthcare outcomes.
Подробное описание
Preoperative anxiety and postoperative pain may negatively affect patients' recovery after surgery. Virtual reality may provide a non-pharmacological method of distraction and relaxation, but its effect on perioperative anxiety and early postoperative recovery requires further evaluation.
This prospective, randomized, parallel-group controlled trial will include approximately 140 adults undergoing elective gynecological surgery. After providing informed consent, participants will be randomized in a 1:1 ratio to one of two groups:
1. Virtual reality plus usual perioperative care. 2. Usual perioperative care alone.
Participants assigned to the intervention group will use a virtual reality headset for approximately 10-20 minutes before surgery and view an immersive relaxation environment. The intervention may be discontinued at any time if the participant experiences discomfort, nausea, dizziness, anxiety, or other adverse symptoms.
The primary outcome is the change in preoperative anxiety from immediately before to immediately after the intervention period, assessed using the State-Trait Anxiety Inventory-State scale and/or a numerical rating scale for anxiety.
Secondary outcomes include quality of recovery measured with the Quality of Recovery-15 questionnaire, postoperative pain measured using a numerical rating scale, opioid consumption expressed as morphine milligram equivalents, postoperative nausea and vomiting, time spent in the postoperative care unit, and other indicators of early postoperative recovery. Follow-up assessments are planned at approximately 24 and 72 hours and on postoperative days 7 and 10.
The study will examine whether preoperative virtual reality reduces anxiety and whether any reduction is associated with improved postoperative recovery and reduced symptom burden.
Вмешательства
- Поведенческое Preoperative Virtual Reality
A single preoperative virtual reality session lasting approximately 10-20 minutes, administered in the waiting or preoperative area. Participants view calm nature, relaxation, or guided-breathing scenes using a virtual reality headset. The intervention is intended to provide relaxation, comfort, and distraction before surgery. - Другое Usual Perioperative Care
Participants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.
Первичные конечные точки
- Quality of Postoperative Recovery Measured With QoR-15 [Срок оценки: 24 hours after surgery]
Вторичные конечные точки (8)
- Change in Preoperative Anxiety [Срок оценки: From immediately before to immediately after the intervention, approximately 10-20 minutes]
- Postoperative Pain Intensity [Срок оценки: Up to 72 hours after surgery]
- Postoperative Opioid Consumption [Срок оценки: During the first 24 hours after surgery]
- Incidence of Postoperative Nausea and Vomiting [Срок оценки: During the first 24 hours after surgery]
- Duration of Stay in the Post-Anesthesia Care Unit [Срок оценки: On the day of surgery]
- Quality of Recovery at 72 Hours Measured With QoR-15 [Срок оценки: 72 hours after surgery]
- Quality of Recovery on Postoperative Day 7 Measured With QoR-15 [Срок оценки: 7 days after surgery]
- Quality of Recovery on Postoperative Day 10 Measured With QoR-15 [Срок оценки: 10 days after surgery]
Критерии участия
Критерии включения
- Adults aged 18 years or older.
- Scheduled to undergo elective gynecological surgery according to the study protocol at a participating center where virtual reality can be provided.
- Able and willing to provide informed consent for study participation, 1:1 randomization, and use of virtual reality.
Критерии исключения
- Increased risk of adverse effects related to virtual reality, including pronounced motion sickness, claustrophobia, or photosensitive epilepsy.
- Active substance use disorder or active misuse of alcohol or illicit drugs.
- Severe chronic pain and/or regular preoperative opioid treatment, as defined in the study protocol.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07679022 · 2026-03077-01 · 2026-03077-01