Assessing the Feasibility of Using Virtual Reality Experiences in Older Adults
調査の概要
詳細な説明
Background and Significance
Seriously ill older adults frequently harbor unfulfilled end-of-life aspirations, commonly referred to as "bucket list" experiences. Advanced illness, functional decline, and the constraints of institutional living typically render travel and other real world experiences largely unattainable for this population. Virtual reality (VR) technology, now widely commercially available, may offer an accessible means of delivering immersive surrogate experiences at the bedside. However, the feasibility of VR engagement among seriously ill nursing home residents - including their capacity to tolerate head-mounted display use, sustain attention during immersion, and derive meaningful benefit - has not been adequately established. The present study seeks to address this gap.
Specific Aims:
- To determine the feasibility of administering immersive VR experiences to seriously ill older adult nursing home residents using a commercially available head-mounted display.
- To compare participant ability to tolerate two distinct VR delivery modalities: computer-generated virtual reality (CG-VR) and film-based virtual reality (FB-VR).
- To explore, through qualitative inquiry, participant perceptions of VR as a vehicle for fulfilling personally meaningful experiences (virtual bucket-listing).
Study Design
This is a feasibility study employing a randomized, two-arm parallel-group design with an optional crossover component and embedded qualitative interviews.
Study Population: Seriously ill older adult residents of the participating nursing home facility.
Study Procedures
Following written informed consent, each participant will be invited to articulate a personal bucket list. Participants who identify one or more bucket list items will be randomly assigned in a 1:1 ratio to one of two arms:
- Arm A: A three-minute immersive waterfall experience delivered via CG-VR.
- Arm B: A three-minute immersive waterfall experience delivered via FB-VR. All VR content will be delivered using the Meta Quest Pro head-mounted display. Following the initial experience, participants will be offered the option to engage in a second VR session - either the alternate modality (CG-VR or FB-VR) or an alternative VR environment of personal significance to the participant.
Outcome Measures:
Primary outcomes (feasibility): Consent, completion of the assigned VR experience, and adverse events (including cybersickness, agitation, or discomfort).
Secondary outcomes:
- Change in symptom burden as measured by pre- and post-experience scores on the Edmonton Symptom Assessment System-Revised (ESAS-r).
- Participant-reported relaxation ratings obtained immediately following the VR experience.
- Qualitative data derived from post-experience semi-structured interviews for thematic analysis.
Risks and Anticipated Benefits:
Risks are anticipated to be minimal and primarily limited to transient cybersickness, mild disorientation, or emotional response to the experiential content. Participants may benefit from symptom relief, relaxation, and engagement with personally meaningful imagery, although direct benefit is not assured. Findings will inform the design of subsequent efficacy trials evaluating VR as a palliative intervention.
Statistical Considerations:
Given that this is a feasibility pilot study, there is no hypothesis testing and the study is not powered to detect efficacy.Descriptive statistics will be employed to characterize feasibility metrics and outcome distributions.
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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California
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Palo Alto、California、アメリカ、94304
- Stanford University
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria: Seriously ill nursing home residents identified by their care team as able to participate.
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Exclusion Criteria: <65 years of age
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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 |
|---|---|
|
アクティブコンパレータ:Computer-generated VR waterfalls
This is a computer-generated VR waterfalls
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Commercially available Meta Quest Pro was used to show a waterfalls virtually to the participants in one of two renderings-- computer generated waterfalls or a film-based waterfalls.
Both types of renderings are viewed by the exact same equipment and headset.
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アクティブコンパレータ:Film-based VR waterfalls
This is a film-based VR waterfalls
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Commercially available Meta Quest Pro was used to show a waterfalls virtually to the participants in one of two renderings-- computer generated waterfalls or a film-based waterfalls.
Both types of renderings are viewed by the exact same equipment and headset.
|
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 |
|---|---|---|
|
Edmonton Symptom Assessment Scale (ESASr)
時間枠:Baseline
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ESAS-r assessed nine common symptoms (Pain, Fatigue, Nausea, Depression, Anxiety, Drowsiness, Shortness of Breath, Appetite, and Wellbeing) on 0-10 scales.
(cite) A sleep item was also included.
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Baseline
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Relaxation scale
時間枠:Immediately before and after the 3-minute VR exposure.
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Relaxation was assessed with a single item (0 = not relaxed at all; 10 = extremely relaxed)
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Immediately before and after the 3-minute VR exposure.
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協力者と研究者
スポンサー
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
その他の研究ID番号
- 67522
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。