NCT06586489

Brief Summary

This randomized controlled trial aims to explore the impact of virtual natural environments on the mental and physical health of older adults in long-term care facilities. A total of 120 participants will be divided into three groups: a virtual reality (VR) group, a tablet screen-based natural environments group (Tab), and a control group (C) receiving routine care. The intervention involves viewing virtual natural landscapes for 10 minutes, three times a week, over eight weeks. The study will evaluate the effectiveness of these virtual environments in enhancing the quality of life for elderly residents, with data collection occurring at multiple time points. Additionally, qualitative interviews will be conducted with VR group participants to capture their experiences and emotional responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
Last Updated

November 17, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

August 29, 2024

Last Update Submit

November 13, 2025

Conditions

Keywords

Virtual RealityNatural EnvironmentsOlder AdultsRandomized Controlled Trial

Outcome Measures

Primary Outcomes (12)

  • Level of Relaxation

    This study will use the Visual Analogue Scale (VAS) for relaxation.The VAS is a 0-100 mm scale, with 0 mm indicating no relaxation and 100 mm indicating a high level of relaxation.

    Immediately before and immediately after each intervention session

  • Temperature

    Measurement of body temperature to monitor physiological changes. Unit of Measure: Degrees Celsius (°C)

    Immediately before and immediately after each intervention session.

  • Heart Rate

    Measurement of heart rate to monitor physiological changes. Unit of Measure: Beats per minute (bpm)

    Immediately before and immediately after each intervention session.

  • Respiration Rate

    Measurement of respiration rate to monitor physiological changes. Unit of Measure: Breaths per minute

    Immediately before and immediately after each intervention session.

  • Blood Pressure

    Measurement of blood pressure to monitor physiological changes. Unit of Measure: Millimeters of mercury (mmHg)

    Immediately before and immediately after each intervention session.

  • Well-being

    This study will use the 10-item version of the Chinese Happiness Inventory (CHI), adapted from the Oxford Happiness Inventory. The scale has 10 items scored on a 4-point Likert scale, ranging from 0 (minimum) to 3 (maximum), with a total score between 0 and 30. Higher scores indicate greater happiness among elderly residents.

    Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

  • Heart Rate Variability (HRV)

    HRV refers to the variation in the intervals between heartbeats (RR interval) and is influenced by both the sympathetic and parasympathetic nervous systems. This study will use the VIPcare Plus Smart Band to collect HRV data, including low frequency (LF) and high frequency (HF) power values, as well as the LF/HF ratio, to assess autonomic nervous system balance

    Immediately before and immediately after each intervention session

  • Emotion

    This study will use the Positive and Negative Emotion Scale to measure the emotional states of residents. The scale has 12 items divided into two subscales: the first 6 items assess positive emotions, and the last 6 items assess negative emotions. It is scored on a 5-point Likert scale. The total score for the Positive Emotion Subscale ranges from 6 to 30, where higher scores indicate stronger positive emotions. The Negative Emotion Subscale has the same score range.

    Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

  • Affect

    The Positive and Negative Affect Schedule (PANAS) will be used to measure emotional states. The scale has 20 items, with 10 items each for positive and negative affect. Higher scores on the Positive Affect Subscale (10-50) indicate higher positive affect, and higher scores on the Negative Affect Subscale (10-50) indicate higher negative affect.

    Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

  • Anxiety

    The Geriatric Anxiety Inventory (GAI) will be used to assess anxiety levels in elderly residents.The inventory has 20 items, with scores of 0 (no symptoms) or 1 (symptoms present), yielding a total score between 0 and 20. Higher scores indicate higher levels of anxiety.

    Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

  • Perceived Stress

    The Perceived Stress Scale (PSS-10) will be used to measure the residents perceived stress levels.

    Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

  • Depression

    The Geriatric Depression Scale-Short Form (GDS-SF) will be used to measure depression levels. The scale consists of 15 items with yes/no responses. The total score ranges from 0 to 15, with higher scores indicating more severe depression.

    Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

Study Arms (3)

Virtual Reality Group (VR)

EXPERIMENTAL

Participants in this group will engage with immersive virtual reality (VR) natural landscapes.

Behavioral: Virtual Reality Natural Landscape Exposure

Tablet Screen Group (Tab)

ACTIVE COMPARATOR

Participants in this group will view natural landscapes on a tablet screen.

Behavioral: Tablet Screen Natural Landscape Exposure

Control Group (C)

NO INTERVENTION

Participants in this group will continue their usual care routine without additional exposure to virtual or screen-based natural environments.

Interventions

Participants will view immersive virtual natural landscapes using virtual reality (VR) headsets for 10 minutes, three times a week, over eight weeks. They will choose the natural landscapes they wish to visit and admire, allowing for personalized engagement with the virtual environment.

Virtual Reality Group (VR)

Participants will watch immersive virtual natural landscapes on a tablet screen for 10 minutes, three times a week, over eight weeks. Participants can select the natural landscapes they prefer to view during the sessions, providing a personalized experience.

Tablet Screen Group (Tab)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older
  • Residency in a long-term care institution for more than 1 month
  • Clear consciousness

You may not qualify if:

  • Blindness
  • Presence of an infectious disease
  • Inability to wear glasses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Taiwan, 11031, Taiwan

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Yeu-Hui Chuang

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 19, 2024

Study Start

September 16, 2024

Primary Completion

October 7, 2025

Study Completion

October 7, 2025

Last Updated

November 17, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data from this study.

Locations