Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units
Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. The main questions it aims to answer are:
- Does VR-based sensory stimulation delay the time to the first delirium event during ICU stay?
- Does VR-based sensory stimulation reduce delirium incidence, duration, and severity?
- What are the effects of the intervention on ICU length of stay, duration of mechanical ventilation, cognitive function at 3 months after ICU discharge, and health-related quality of life? Researchers will compare immersive VR-based sensory stimulation with a non-immersive tablet-based active control to assess the added value of immersion beyond the effects of sensory content alone.
Participants will:
- Receive either immersive VR-based sensory stimulation or tablet-based sensory stimulation
- Receive one 20-minute session per day for up to 3 days during ICU stay Undergo twice-daily delirium assessments during ICU stay Complete follow-up assessments of cognitive function and health-related quality of life at 3 months after ICU discharge
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Delirium is a common acute neurocognitive disorder in critically ill patients and is associated with poor short- and long-term outcomes, including prolonged ICU stay, extended mechanical ventilation, persistent cognitive impairment, and reduced quality of life after discharge. Environmental factors in the ICU, particularly sensory deprivation and excessive noise and light disturbance, are recognized as modifiable contributors to delirium risk.
Conventional sensory stimulation has shown potential to delay delirium onset and reduce delirium severity in ICU patients. However, implementation in routine ICU practice is challenging because intervention delivery may be disrupted by the complex ICU environment and may vary across clinical staff and settings.
This study evaluates a virtual reality (VR)-based sensory stimulation intervention designed to provide immersive visual and auditory input while reducing interference from the ICU environment. The intervention uses a head-mounted display and headphones to deliver standardized nature-based content. An active control condition was selected to receive the same content through a tablet, allowing comparison of immersive versus non-immersive delivery while controlling for the sensory content itself.
This study is a pilot randomized controlled trial conducted in adult ICU patients. Participants are randomly assigned in a 1:1 ratio to either the VR intervention group or the active control group. Both groups receive one 20-minute session daily for up to 3 days during ICU stay. Delirium is assessed twice daily during ICU stay, and participants are followed at 3 months after ICU discharge for cognitive and quality-of-life outcomes. The study is intended to generate preliminary estimates of intervention effects and to inform the design of a future definitive trial.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Guangdong
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Shenzhen, Guangdong, 중국, 518133
- 모병
- Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
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연락하다:
- Liang Judy, PhD
- 전화번호: 37256297
- 이메일: liangsr5@alumni.sysu.edu.cn
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years or older
- Admitted to the ICU
- Undergoing or expected to require mechanical ventilation
- Expected ICU stay of at least 48 hours
- Awake or lightly sedated, defined as a Richmond Agitation-Sedation Scale - (RASS) score between -1 and +1
- Able to understand and follow instructions
- Provided informed consent [or surrogate consent, if applicable]
Exclusion Criteria:
- Pre-existing cognitive impairment or dementia
- Acute psychiatric illness at admission
- Delirium at enrollment as assessed by CAM-ICU
- Terminal-stage cancer
- APACHE II score > 20
- Severe uncorrectable hearing or visual impairment
- Traumatic brain injury or intracranial drainage tubes that make use of the VR headset impractical
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: immersive VR group
Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones.
The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
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Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones.
The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
|
|
활성 비교기: active control group
Participants received the same nature-based audiovisual content delivered through a tablet-based non-immersive format.
Sessions were delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
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Participants received the same nature-based audiovisual content through a tablet in a non-immersive format for 20 minutes once daily for up to 3 days during ICU stay.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to First Delirium Event During ICU Stay
기간: Every day, from ICU admission to ICU discharge, assessed up to 28 days
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Time from study enrollment to the first episode of delirium detected by the Confusion Assessment Method for the ICU (CAM-ICU).
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Every day, from ICU admission to ICU discharge, assessed up to 28 days
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Delirium Incidence
기간: Every day, from ICU admission to ICU discharge, assessed up to 28 days
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Proportion of participants who developed delirium during ICU stay as assessed by CAM-ICU.
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Every day, from ICU admission to ICU discharge, assessed up to 28 days
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Delirium Duration
기간: Every day, from ICU admission to ICU discharge, assessed up to 28 days
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Total number of days during which delirium was present during ICU stay.
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Every day, from ICU admission to ICU discharge, assessed up to 28 days
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ICU Length of Stay
기간: From date of ICU admission until the date of ICU discharge, assessed up to 28 days
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Total number of days from ICU admission to ICU discharge.
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From date of ICU admission until the date of ICU discharge, assessed up to 28 days
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Duration of Mechanical Ventilation
기간: From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days
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Total duration of mechanical ventilation during ICU stay.
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From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days
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Cognitive Function at 3 Months
기간: 3 months after ICU discharge
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Cognitive function assessed by the telephone-based Montreal Cognitive Assessment (t-MoCA).
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3 months after ICU discharge
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Health-Related Quality of Life at 3 Months
기간: 3 months after ICU discharge
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Health-related quality of life assessed by the EuroQol Five Dimensions Questionnaire (EQ-5D).
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3 months after ICU discharge
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- NYSZYYEC20230074R003
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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