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Набор скоро начнётся NCT07482722

Virtual Reality-Based Transitional Care for ICU Survivors

Без фазы С лечением Critical Illness Stress, Psychological Intensive Care Units

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: Virtual Reality-Based Transitional Care.
Кому может быть актуально
Состояния в реестре: Critical Illness, Stress, Psychological, Intensive Care Units. Базовые параметры: от 20 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Impact of a Virtual Reality-Based Transitional Care Program on Heart Rate Variability, Pain, Relocation Stress, and Unplanned ICU Readmission Among Adult ICU Survivors: A Randomized Controlled Trial

Обзор

This study aims to evaluate the effectiveness of a virtual reality (VR)-based transitional care program for adult survivors of intensive care unit (ICU) care. ICU survivors frequently experience relocation stress, anxiety, pain, and physiological instability after transfer from the ICU to general wards, which may increase the risk of unplanned ICU readmission. Participants will be randomly assigned to receive either standard transitional care or additional VR-based intervention sessions during their ICU stay. The VR intervention is designed to provide psychological support, environmental orientation, and stress reduction. Primary outcomes include short-term physiological indicators within 48 hours after ICU transfer. Secondary outcomes include pain, relocation stress, and unplanned ICU readmission within 7 days.

Подробное описание

This is a single-center, randomized controlled trial designed to investigate the effects of a virtual reality (VR)-based transitional care intervention on physiological stability and psychological adaptation among adult ICU survivors.

Critically ill patients often experience relocation stress syndrome following transfer from the ICU to general wards. This transition period is associated with increased anxiety, pain perception, autonomic imbalance, and a higher risk of unplanned ICU readmission.

Eligible participants will be randomized using block randomization into the intervention or control group. The intervention group will receive three VR sessions during their ICU stay in addition to standard transitional care. The control group will receive standard care alone.

The primary outcome is short-term physiological stability measured within 48 hours after ICU transfer. Secondary outcomes include heart rate variability parameters, pain intensity, relocation stress, and unplanned ICU readmission within 7 days.

This study seeks to determine whether VR-assisted transitional care can enhance recovery, reduce stress-related responses, and improve patient outcomes following ICU discharge.

Вмешательства

  • Поведенческое Virtual Reality-Based Transitional Care
    Participants assigned to this arm will receive three structured virtual reality (VR) sessions during their ICU stay in addition to standard transitional care. Each VR session is designed to provide environmental orientation, psychological support, and stress reduction through immersive audiovisual content. The intervention aims to improve short-term physiological stability and reduce relocation stress following ICU transfer.

Первичные конечные точки

  • Heart Rate Variability - RMSSD [Срок оценки: Within 48 hours after transfer from the ICU to the general ward]
  • Heart Rate Variability - High Frequency Power [Срок оценки: Within 48 hours after transfer from the ICU to the general ward]
Вторичные конечные точки (3)
  • Pain Intensity [Срок оценки: Within 48 hours after ICU transfer]
  • Unplanned ICU Readmission [Срок оценки: Within 7 days after ICU transfer]
  • Relocation Stress [Срок оценки: Within 48 hours after ICU transfer]

Критерии участия

Критерии включения

  • Age 20 years or older
  • Adult patients admitted to the intensive care unit (ICU)
  • Planned transfer from ICU to the general ward
  • Able to communicate and provide informed consent or have a legal representative provide consent

Критерии исключения

  • Severe cognitive impairment or delirium preventing participation
  • Severe visual or hearing impairment interfering with VR use
  • Hemodynamic instability requiring immediate life-saving intervention
  • Isolation precautions prohibiting device use
  • Participation in another interventional study that may affect outcomes

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

Тайвань · 2 центра
  • MacKay Memorial Hospital — Taipei
  • MacKay Memorial Hospital, Tamsui Branch — New Taipei City

Идентификаторы

NCT: NCT07482722 · 24MMHIS535e

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗