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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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

80

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Barcelona
      • Vic, Barcelona, 스페인, 08500
        • University of Vic-Central University of Catalonia (UVIC-UCC)

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
위약 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Barthel Index
기간: 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.
기간: 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.
기간: 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.
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Quantitative data: Simulator Sickness Questionnaire (SSQ).
기간: 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.
기간: 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).
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Maite Garolera, PhD, Consorci Sanitari de Terrassa
  • 수석 연구원: Salvador Simó-Algado, PhD, University of Vic-Central University of Catalonia (UVIC-UCC)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 4월 16일

기본 완료 (실제)

2024년 6월 17일

연구 완료 (실제)

2024년 6월 17일

연구 등록 날짜

최초 제출

2026년 3월 27일

QC 기준을 충족하는 최초 제출

2026년 9월 9일

처음 게시됨 (실제)

2026년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CEIm IRIS-CC 23/018

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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