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Clinic Validation of Three Virtual Reality Environments.

Therapeutic Virtual Blue Spaces: Immersive Virtual Environments to Promote the Emotional Well-being of Intermediate Unit Patients.

Background: The healthcare sector has particularly embraced Virtual Reality (VR) applications, demonstrating its efficacy in creating relaxing virtual environments reduce stress and anxiety symptoms. Recent investigations highlight the therapeutic value of nature-based "Head Mounted Display" (HMD)-VR environments as accessible and low-intensity interventions.

Aim: The aim is the health validation of three HMD-VR environments to promote emotional well-being and improve the mood of patients in intermediate units.

Methods: This research uses mixed methodology to validate three VR immersive environments with human-centred design and verify their impact with a study sample consisting of 80 patients from the Intermediate units; 50 women and 30 men, of whom 40 participants viewed the three environments in 3D 360° VR on HMD, and 40 participants viewed the same three environments in 2D on tablets. All participants answered the Positive and Negative Affect Schedule Questionnaire (PANAS), the Slater-Usoh-Steed (SUS), and the Simulator Sickness Questionnaire (SSQ).

調査の概要

詳細な説明

This study was conducted in two phases. Phase I aimed to examine short-term affective changes following exposure to the developed VR environments, to assess perceived presence, and to evaluate adverse VR sickness symptoms in hospitalized patients. Phase II aimed to evaluate the intervention's impact on patients and the perspectives of key informants within the health centres.

The study was a multicentre experimental study with a pretest-posttest, cross-sectional design and used a mixed-methods approach combining quantitative and qualitative data.

This study conducted prior research to design and create three virtual reality (VR) person-centred design environments inspired by the contributions of people monitored by the Home Care Service of Manlleu City Council. The prior study aimed to identify the characteristics of HMD-VR environments most closely associated with emotional well-being in adults requiring support for daily activities. Results indicated a clear preference for natural landscapes that are highly realistic and free of digital or artificial elements. Additionally, natural elements such as vegetation, flowers, trees, and clear water were repeatedly highlighted as desirable. Regarding auditory components, natural sounds, particularly birdsong, the breeze, and the sound of sea waves, were strongly valued. Participants also valued creative and interactive audiovisual elements. Although the interactive artistic experience was well received, the final design of the environments prioritized simplicity and ease of use to ensure accessibility for the population with cognitive, sensory, or mobility limitations. Full descriptions of the VR environments are included in Annex 1.

To establish implementation procedures and timelines, coordination meetings were conducted with hospital administrators and healthcare coordinators at the two participating sites (HSJM-CHV and HUSC-FHSC) following the development of the three HMD-VR scenarios. Medical staff selected appropriate participants based on established inclusion and exclusion criteria.

Following a period of HMD-VR acclimatization with technician-facilitated headset fitting, participants underwent the VR session under constant supervision. Continuous monitoring was employed to detect any VR adverse effects (e.g., dizziness, eye strain). Immediate attention from the medical professional present was received if any participant reported discomfort. No participants discontinued or withdrew from the study.

A dedicated, isolated room containing one table and two chairs was set up in each Intermediate Unit to maintain controlled experimental conditions. Due to mobility impairments, five participants completed the study from their hospital rooms. Of these, four were lying in bed, while one was seated in a chair next to the bed.

Each participant first provided informed consent using printed information sheets and dual consent verification in both paper and electronic formats. Those who declined participation were excluded from the study.

Participants visualized three environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D 360° on tablets.

Each participant completed a questionnaire (10-15 minutes) and was then randomly assigned to one of the three environments. All participants (Group A and Group B) experienced the three environments in alternating order. The total participation time was approximately 60 minutes per individual.

Feedback from key informants was obtained to complement participant data. Healthcare workers completed a separate 10-minute electronic survey designed to collect their professional observations regarding the system's potential impact on patient care, alongside basic demographic and position data. Informed consent was secured from all staff members before survey completion.

研究の種類

介入

入学 (実際)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Barcelona
      • Vic、Barcelona、スペイン、08500
        • University of Vic-Central University of Catalonia (UVIC-UCC)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

はい

説明

Inclusion criteria.

  • Patients of the Intermediate Unit at either of two hospitals: the Hospital de Sant Jaume de Manlleu or the University Hospital of Santa Creu de Vic.
  • Individuals aged 18 years or older were included.
  • Participation in the study was voluntary, and all individuals provided written informed consent before enrolment.
  • Both men and women were eligible, seeking a balanced gender distribution and patient willingness.

Exclusion criteria:

  • Binocular or auditory anomalies.
  • Pre-existing psychiatric disorders.
  • Serious medical conditions (e.g., cardiovascular disease, epilepsy, or implanted electronic devices like pacemakers) that could be negatively impacted by HMD-VR technology.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Group A
Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos
The study validated three HMD-VR environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D on tablets.
プラセボコンパレーター:Grup B
Group B (control group) viewed the same content in 2D on tablets.
The study validated three HMD-VR environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D on tablets.

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
Barthel Index
時間枠:Baseline.
The Barthel Index is a standardized, ordinal scale used to measure a person's level of independence in performing Activities of Daily Living (ADLs). It is one of the most widely used functional assessment tools in clinical and research settings, particularly in geriatrics, rehabilitation, neurology, and nursing.
Baseline.
Pfeiffer scale.
時間枠:Baseline.
The Pfeiffer Scale is a brief, widely used screening instrument designed to detect the presence and severity of cognitive impairment in older adults.
Baseline.
Quantitative data: the Positive and Negative Affect Schedule (PANAS) was used to assess baseline emotional state of the three VR enviroments.
時間枠:Day 2. Baseline and Post-intervention.
Emotional changing state was assessed after the three VR enviroments. To assess changes in affect before and after exposure to each VR environment, paired-samples tests were used based on the PANAS scale's distribution.
Day 2. Baseline and Post-intervention.
Qualitative data: a six-item multiple-choice questionnaire was administered to assess participants' subjective experience of the study.
時間枠:Day 3. Post-intervention.
The questionnaire was developed based on a review of previous studies evaluating virtual reality experiences with vulnerable groups.
Day 3. Post-intervention.

二次結果の測定

結果測定
メジャーの説明
時間枠
Quantitative data: Simulator Sickness Questionnaire (SSQ).
時間枠:Day 2. Baseline and Post-intervention.
Evaluates physical discomfort using sixteen items rated from "none" to "severe".
Day 2. Baseline and Post-intervention.
Quantitative data: he Slater-Usoh-Steed (SUS) Presence Questionnaire.
時間枠:Day 2. Post-intervention.
to measure perceived presence and immersion of the three VR enviroments.
Day 2. Post-intervention.
Qualitative data: fourteen-item semi-structured questions to key informants (hospital staff).
時間枠:Day 3. Post-intervention.
key informants answered fourteen-item semi-structured questions about their subjective observation of the study's impact on residents.
Day 3. Post-intervention.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Maite Garolera, PhD、Consorci Sanitari de Terrassa
  • 主任研究者:Salvador Simó-Algado, PhD、University of Vic-Central University of Catalonia (UVIC-UCC)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年4月16日

一次修了 (実際)

2024年6月17日

研究の完了 (実際)

2024年6月17日

試験登録日

最初に提出

2026年3月27日

QC基準を満たした最初の提出物

2026年9月9日

最初の投稿 (実際)

2026年9月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CEIm IRIS-CC 23/018

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