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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Ankara、トルコ（Türkiye）
- Çankırı Karatekin University
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Temperature
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Seher Gönen Şentürk, PhD、Çankırı Karatekin University, Faculty of Health Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ÇAKÜ-SBF-NCD-01
- SBF111224L11 (その他の助成金/資金番号：Cankiri Karatekin University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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