Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)
A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study
Background. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress.
Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.
調査の概要
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Mexico City、メキシコ
- Regional Hospital No. 25 of the IMSS
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- all patients who undergo ambulatory surgical operations and sign informed consent
Exclusion Criteria:
- death or blind patients
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:階乗代入
- マスキング:なし(オープンラベル)
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:1
Virtual reality exposure to a relaxing virtual environment.
The virtual experience will be provided using immersive equipment.
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The Green Valley, a non interactive, relaxing environment showing a mountain landscape around a calm lake is presented to the patient together with the relaxing music and soft sounds (birds' songs, the water flowing, etc). Having the impression of walking around the lake, patients can observe the nature and virtually seat on a comfortable deck chair, in order to become easily relaxed. Patients were exposed to the virtual environment for the entire length of the operation. |
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実験的:2
Exposure to relaxing music.
The music will be selected between classical music tunes.
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A relaxing music and nature sounds have been used to provide a calm atmosphere and reduce stress.
In the Music group it was provided to the patients through earphones with no visual stimulation.
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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 |
|---|---|---|
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Psychological measure of anxiety (VAS-A)
時間枠:One day before operation; one hour after operation; one week after operation
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Change from baseline in the level of anxiety
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One day before operation; one hour after operation; one week after operation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Physiological parameter (heart rate)
時間枠:One day before operation; one hour after operation; one week after operation
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Change from baseline in the heart rate
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One day before operation; one hour after operation; one week after operation
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協力者と研究者
捜査官
- スタディディレクター:Giuseppe Riva, PHD、Istituto Auxologico Italiano
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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