このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

The Personalized Creation of Immersive Virtual Environments to Promote Emotional Well-being

A Proof-of-Concept Study: The Personalized Creation of Immersive Virtual Environments to Promote Emotional Well-being in Older Adults

Background: Virtual Reality (VR) technology has seen a growing adoption in clinical and healthcare settings. VR applications are both effective and acceptable, with a great potential for populations with mobility restrictions, such as older adults receiving home-based care or in long-term care facilities. However, creating head-mounted display virtual reality (HMD-VR) environments still faces considerable challenges.

Aim: The aim is to create three HMD-VR environments and to carry out a proof of concept to verify their impact on older adults.

Methods: This research uses mixed methodology to design three immersive environments with human-centred design and verify its impact with a study sample consisting of 31 people; 18 women and 13 men, of whom 16 were over 89 years old, 11 were between 79 and 89 years old, and 4 people were between 66 and 77 years old. Each participant viewed the three virtual reality environments and answered the Positive and Negative Affect Schedule (PANAS) scale, the Slater-Usoh-Steed (SUS) Presence Questionnaire, and the Simulator Sickness Questionnaire (SSQ).

調査の概要

状態

完了

条件

詳細な説明

Phase I was based on observational, cross-sectional, and mixed-method (quantitative and qualitative) approaches. Phase II was based on a multicentre pre-post quasi-experimental pilot study (proof-of-concept feasibility study) with a cross-sectional design and used a mixed methodology approach combining quantitative and qualitative data.

Phase I was conducted with users of the Home-Based Care (HBC) of the Manlleu City Council, located in the province of Barcelona (Spain). Initial contact and recruitment took place in September 2023, during which potential participants were informed about the aims and procedures of the study. Data collection among eligible HBC users was conducted in November 2023. The inclusion and exclusion criteria were applied jointly with the HBC technical staff to ensure the suitability and safety of the participants.

Phase II was implemented in five residential centres for older adults: La Bona Mar, Vida per l'Avi, Sant Marc, Llar per l'Avi, and Vida als Anys, located in the municipalities of Vilassar de Mar and Mataró (Spain). The centres were first contacted in December 2023, followed by a coordination meeting with the multidisciplinary teams (including social workers, social educators, psychologists, and physiotherapists). Participant selection and recruitment were performed in January 2024, in collaboration with the professional staff of each centre. All eligible residents were considered, considering the clinical criteria. Data collection with residents took place in January and February 2024. In March 2024, additional data were collected from the multidisciplinary teams to obtain their perceptions of the intervention's impact.

Phase I followed a standardized protocol designed to ensure the safe and comfortable use of the HMD-VR device by participants with personal vulnerability factors. The protocol was developed in accordance with recommendations for HMD-VR use in vulnerable populations and considering social and mental health aspects described in recent research.

The protocol was briefly described as follows: an HMD-VR acclimatization period was included, and assistance was provided for properly fitting the HMD-VR headset. A technician provided continuous supervision throughout the session. To ensure immersion and prevent distraction, participants always remained seated within a closed room to block out external sounds during the HMD-VR exposure.

A questionnaire was developed to collect information on participants' preferences, experiences, and relevant elements for the creation of the VR environments. Its structure and content were based on previous work evaluating VR experiences in vulnerable groups.

Participant selection was performed by the management team of the Home Care Service, in collaboration with each participant's reference professional, ensuring full adherence to the inclusion and exclusion criteria.

Data collection took place in participants' homes. Each participant was exposed to four HMD-VR environments presented in random order (alternating order), followed by completion of the questionnaire. The complete session lasted approximately 60 minutes. The technician continuously monitored participants throughout the session for adverse effects (e.g., dizziness, eye strain).

In Phase II, the standardized protocol was also followed. An HMD-VR acclimatization period was included with assistance from the technician to fit the headset correctly. VR Adverse effects (e.g., dizziness, eye strain) were continuously monitored throughout the session. Participants remained seated in a closed room that blocked external noise during the entire VR exposure to guarantee immersion and avoid distractions.

First, a meeting was held with the management and multidisciplinary teams (e.g., social workers, psychologists, physiotherapists) to determine the sample and schedule. Individual data collection sessions were conducted in a designated room at each of the five centers, using the Oculus Quest 2 HMD-VR system.

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

Finally, center staff completed a 10-minute electronic questionnaire (Microsoft Forms) to assess the study's impact on residents, providing sociodemographic, role-related, and impact feedback after providing informed consent.

研究の種類

観察的

入学 (実際)

31

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

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

This study was conducted in two phases. Phase I aimed to identify the characteristics of VR environments most closely associated with emotional well-being in adults requiring support with daily activities. Phase II was a proof-of-concept study with three aims: 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 older adults with support needs.

説明

Inclusion Criteria:

  • Gender (preference for equality between men and women).
  • Users of the Home Care Service (SAD) and elderly people from the five residential centres.
  • Age (first phase over 18 years old and second phase over 65 years old).
  • Participation in this study was completely voluntary, and all participants signed an informed consent form before taking part in the research.

Exclusion Criteria:

  • People who suffer from any anomaly in binocular or auditory vision.
  • People with physical or mental disabilities, or pre-existing psychiatric disorders, with serious medical conditions.
  • People who suffer from any cardiovascular disease are susceptible to being affected by HMD-VR technology.
  • People who suffer from symptoms related to epilepsy.
  • People who have any electronic device, such as a cardiac pacemaker or other implanted medical device susceptible to being altered 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

コホートと介入

グループ/コホート
Home Care Service.
Users of the Home Care Service (SAD) of the Manlleu City Council.
Residents.
users of five older adult residences.
Staff.
Multidisciplinary team working in the five residential centres.

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
Phase I quantitative data: Assessing their perceptions of the four VR environments (realistic, digital, dreamlike, and interactive),
時間枠:Day 1. Baseline.

Participants completed three Likert-scale items assessing their perceptions of the four VR environments (realistic, digital, dreamlike, and interactive), together with one categorical item indicating overall preference.

Quantitative Phase I, composed of three questions with a Likert response scale that measure the assessment of the four different experiences (realistic, digital, dreamlike, and interactive) with the VR glasses, and a nominal categorical question with three levels.

Day 1. Baseline.
Phase I qualitative data. Participants answered 13 semi-structured interview questions about the contexts (e.g., environments, sounds) they linked to emotional well-being.
時間枠:Day 1. Baseline.

Collect information on which aspects (environments, sounds, images, etc.) and experiences are most relevant in VR environments regarding the emotional well-being of the participants to desing three VR enviroments.

Phase I qualitative data consisted of semi-structured interviews of thirteen questions.

Day 1. Baseline.
Phase II 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.

Verify that the three HMD-VR environments created significantly favourable positive emotions in the participants related to emotional well-being and improved mood.

Verify that the three HMD-VR environments created significantly decrease negative emotions in the participants related to emotional well-being and improved mood.

Day 2. Baseline and Post-intervention.

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase II quantitative data: The Slater-Usoh-Steed (SUS) Presence Questionnaire to measure perceived presence and immersion
時間枠:Day 2. Post-intervention.
Verify the degree of immersion generated in the three HMD-VR environments created in the participants.
Day 2. Post-intervention.
Phase II quantitative data: The Simulator Sickness Questionnaire (SSQ) to evaluate physical symptoms associated with HMD-VR exposure.
時間枠:Day 2. Post-intervention.
Verify the VR Sickness symptoms after exposure to the three HMD-VR environments created.
Day 2. Post-intervention.
Phase II qualitative data: Key informants perception (staff).
時間枠:Day 3. Post-intervention.
Evaluate the impact of the study on the residents through the perception of the staff at the centres. In Phase II, key informants answered 14 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。

スポンサー

協力者

捜査官

  • 主任研究者:Salvador Simó, 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。

一般刊行物

  • Anderson, A. P., Mayer, M. D., Fellows, A. M., Cowan, D. R., Hegel, M. T., and Buckey, J. C. (2017). Relaxation with immersive natural scenes presented using virtual reality. Aerospace medicine and human performance, 88(6), 520-526. https://doi.org/10.3357/AMHP.4747.2017 Appel, L., Appel, E., Bogler, O., Wiseman, M., Cohen, L., Ein, N., Abrams, H. B., and Campos, J. L. (2020). Older adults with cognitive and/or physical impairments can benefit from immersive virtual reality experiences: a feasibility study. Frontiers in Medicine, 6, 329-329. https://doi.org/10.3389/fmed.2019.00329 Bimberg, Pauline and Weissker, Tim and Kulik, Alexander. (2020). On the usage of the simulator sickness questionnaire for virtual reality research. 464-467. 10.1109/VRW50115.2020.00098. Birckhead, B., Khalil, C., Liu, X., Conovitz, S., Rizzo, A., Danovitch, I., Bullock, K., & Spiegel, B. (2019). Recommendations for methodology of virtual reality clinical trials in health care by an international working group: Iterative Study. JMIR mental health, 6(1), e11973. https://doi.org/10.2196/11973 Brungardt, A., Wibben, A., Shanbhag, P., Boeldt, D., Youngwerth, J., Tompkins, A., Rolbiecki, A. J., Coats, H., LaGasse, A. B., Kutner, J. S., & Lum, H. D. (2024). Patient outcomes of a virtual reality-based music therapy pilot in palliative care. Palliative medicine reports, 5(1), 278-285. https://doi.org/10.1089/pmr.2024.0022 Bryant, Brunner, M., and Hemsley, B. (2020). A review of virtual reality technologies in the field of communication disability: implications for practice and research. Disability and Rehabilitation: Assistive Technology, 15(4), 365-372. https://doi.org/10.1080/17483107.2018.1549276 Clemente, D., Romano, L., Zamboni, E., Carrus, G., & Panno, A. (2024). Forest therapy using virtual reality in the older population: a systematic review. Frontiers in Psychology, 14, 1323758-1323758. https://doi.org/10.3389/fpsyg.2023.1323758 Cullen, A.J., Dowling, N.L., Segrave, R. et al. Considerati

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)

2023年12月1日

一次修了 (実際)

2024年3月15日

研究の完了 (実際)

2024年4月15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2日

最初の投稿 (実際)

2026年9月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9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2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

  • UVic-UCC. Project num.277/2023

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。