Effect of Virtual Reality on Agitation in Acute Stroke
The Effect of Virtual Reality Application on Agitation in Individuals With Acute Stroke: A Randomized Controlled Single-Blind Study
연구 개요
상태
상세 설명
Stroke is a sudden medical condition that affects the brain. During the acute phase of a stroke, many patients experience agitation, which means feeling restless, anxious, or uncooperative. Agitation can complicate medical care and negatively affect a patient's recovery and vital signs (such as heart rate and blood pressure).
The main purpose of this study is to evaluate whether using a Virtual Reality (VR) application helps reduce agitation levels and stabilize vital signs in individuals who have experienced an acute stroke.
This is a randomized controlled, single-blind clinical trial. Participants with acute stroke will be randomly assigned to one of two groups:
Intervention Group: Participants will receive a structured Virtual Reality (VR) application session in addition to their routine stroke care.
Control Group: Participants will receive standard routine clinical care and monitoring without the VR application.
Researchers will measure and compare the participants' agitation levels using a clinical evaluation scale before and after the intervention. In addition, physiological vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation) will be closely monitored to determine the effects of the VR therapy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara, 터키 (Türkiye)
- Çankırı Karatekin University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
* Individuals who have passed 48 hours post-acute CVA (being in the acute phase of stroke treatment, stroke duration not exceeding the first 4 weeks)
- Having a score of 0 on the Wong-Baker FACES Pain Rating Scale
- Having a score of at least +2 or higher on the Richmond Agitation-Sedation Scale (RASS)
- Being 18 years of age or older
- Having a GCS score of 13 or higher
- Having no hearing or visual impairments
- Not being in contact isolation due to a contagious disease
- Being literate in Turkish
- Not being administered sedation
- Being awake and hemodynamically stable
- Being able to sit in high Fowler's position
- Individuals without mechanical ventilation support
Exclusion Criteria:
Presence of nausea and vomiting
- Mobility restriction and sensitivity to claustrophobia
- Presence of delirium
- Presence of schizophrenia and dementia
- Presence of vertigo and Meniere's disease
- Having a pain score of 1 point or higher
- Having facial damage to the extent that a virtual reality headset cannot be worn
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Group
Participants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management.
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Participants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation.
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활성 비교기: Control Group
Participants in this arm receive standard routine clinical stroke care and monitoring alone, without any Virtual Reality intervention.
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Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Body Temperature
기간: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of body temperature (°C) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Heart Rate
기간: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of heart rate (beats/min) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Blood Pressure
기간: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of blood pressure (mmHg) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Respiratory Rate
기간: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of respiratory rate (breaths/min) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Oxygen Saturation
기간: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Assessment of oxygen saturation (SpO2, %) evaluated across three time points.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Change in Agitation Levels
기간: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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Agitation levels evaluated using a validated clinical agitation rating scale across three time points (pre-intervention, immediately post-intervention, and post-intervention) to assess changes in patient agitation.
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Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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공동 작업자 및 조사자
수사관
- 연구 책임자: Seher Gönen Şentürk, PhD, Çankırı Karatekin University, Faculty of Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ÇAKÜ-SBF-NCD-01
- SBF111224L11 (기타 보조금/기금 번호: Cankiri Karatekin University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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