- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06586489
The Effects of Virtual Natural Environments on Residents' Health
The Effects of Virtual Natural Environments in Improving Older Residents' Physical and Psychological Health in Long-term Care Facilities
Study Overview
Status
Conditions
Detailed Description
This study investigates whether virtual natural environments can improve the mental and physical health of older adults living in long-term care facilities. The trial will involve 120 participants randomly assigned to one of 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 consists of viewing virtual natural landscapes for 10 minutes, three times a week, over an eight-week period.
The study's primary focus is to assess the impact of these virtual environments on participants' overall well-being and quality of life. Data will be collected at multiple stages throughout the intervention, and statistical analysis will be conducted to determine the effectiveness of the virtual nature sessions. In addition to the quantitative analysis, qualitative interviews will be carried out with participants in the VR group to gather deeper insights into their experiences and the emotional benefits they may derive from the intervention. These interviews will provide valuable context to the quantitative findings, helping to understand the broader implications of using virtual natural environments in long-term care settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taiwan
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Taipei, Taiwan, Taiwan, 11031
- Taipei Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 60 years or older
- Residency in a long-term care institution for more than 1 month
- Clear consciousness
Exclusion Criteria:
- Blindness
- Presence of an infectious disease
- Inability to wear glasses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual Reality Group (VR)
Participants in this group will engage with immersive virtual reality (VR) natural landscapes.
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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.
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Active Comparator: Tablet Screen Group (Tab)
Participants in this group will view natural landscapes on a tablet screen.
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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.
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No Intervention: Control Group (C)
Participants in this group will continue their usual care routine without additional exposure to virtual or screen-based natural environments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of Relaxation
Time Frame: Immediately before and immediately after each intervention session
|
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.
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Immediately before and immediately after each intervention session
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Temperature
Time Frame: Immediately before and immediately after each intervention session.
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Measurement of body temperature to monitor physiological changes.
Unit of Measure: Degrees Celsius (°C)
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Immediately before and immediately after each intervention session.
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Heart Rate
Time Frame: Immediately before and immediately after each intervention session.
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Measurement of heart rate to monitor physiological changes.
Unit of Measure: Beats per minute (bpm)
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Immediately before and immediately after each intervention session.
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Respiration Rate
Time Frame: Immediately before and immediately after each intervention session.
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Measurement of respiration rate to monitor physiological changes.
Unit of Measure: Breaths per minute
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Immediately before and immediately after each intervention session.
|
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Blood Pressure
Time Frame: Immediately before and immediately after each intervention session.
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Measurement of blood pressure to monitor physiological changes.
Unit of Measure: Millimeters of mercury (mmHg)
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Immediately before and immediately after each intervention session.
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Well-being
Time Frame: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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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.
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Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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Heart Rate Variability (HRV)
Time Frame: Immediately before and immediately after each intervention session
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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
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Immediately before and immediately after each intervention session
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Emotion
Time Frame: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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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.
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Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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Affect
Time Frame: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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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.
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Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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Anxiety
Time Frame: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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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.
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Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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Perceived Stress
Time Frame: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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The Perceived Stress Scale (PSS-10) will be used to measure the residents perceived stress levels.
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Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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Depression
Time Frame: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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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.
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Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yeu-Hui Chuang, Taipei Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202304015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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