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Explore the Effects of Virtual Reality Natural Environment of Older People

Primary Purpose

Older People

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Stage 1 Experimental A group: actual natural environment
Stage 1 Experimental B group: virtual reality natural environment
Stage 1 Control group: city environment
Stage 2 group
Stage 3 Experimental group: virtual reality natural environment
Stage 3 Control group: routine care
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Older People focused on measuring Elders, Attention, Emotion, Cognitive function, natural environment, virtual reality, Mild cognitive impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Stage 1 Inclusion Criteria: Age 65 years and older in Taipei City Cognitive function is normal (SPMSQ >8) The subjects can communicate in Chinese or Taiwanese. Exclusion criteria: Diseases affecting the results of the study, such as mental illness Vision or hearing problems Diseases transmitted by eyes or skin People with difficulty in walking. (The SPMSQ test was performed before the intervention to screen the cognitive function of the subjects). Stage 2 and 3 Inclusion Criteria: Age 65 years and older living in Institution for 6 months of more The subjects can communicate in Chinese or Taiwanese. Exclusion criteria: Diseases affecting the results of the study, such as mental illness Vision or hearing problems Diseases transmitted by eyes or skin People with dementia diagnosis or screening SPMSQ < 6 (The SPMSQ test was performed before the intervention to screen the cognitive function of the subjects).

Sites / Locations

  • National Yang Ming Chiao Tung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Other

Experimental

Active Comparator

Arm Label

Stage 1 Experimental A group: Actual experience of nature environment

Stage 1 Experimental B group: virtual reality experience of nature environment

Stage 1 Control group: actual experience of city

Stage 2 group

Stage 3 Experimental group

Stage 3 Control group

Arm Description

actual natural environment

virtual reality experience of nature environment

actual experience of city

tree element virtual natural environment and tree and water element virtual natural environment experiences

virtual reality experience of nature environment

routine care

Outcomes

Primary Outcome Measures

Perceived Restorativeness Scale
To measure attention Restoration.
Digit span test
To measure attention.
Trail Making Test
To measure attention.
The Positive and Negative Affect Schedule
To measure emotion.
The Montreal Cognitive Assessment
To measure Cognitive function.
Depression, Anxiety and Stress Scale
To measure short-term emotion

Secondary Outcome Measures

Blood pressure, heart rate and heart rate variability
measure the participant's sitting blood pressure, heartbeat and heart rate variability.
Qualitative experience
At the end of the study, feelings about watching the virtual reality and suggestion

Full Information

First Posted
March 13, 2023
Last Updated
April 26, 2023
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05803460
Brief Title
Explore the Effects of Virtual Reality Natural Environment of Older People
Official Title
Develop and Explore the Effects of Virtual Reality Based Natural Environment Intervention Programs on Improving Attention, Emotion, and Cognitive Function of Elders With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to develop and explore the effects of virtual reality based natural environment intervention programs on improving attention, emotion, and cognitive function of older people. The study has three stage. The first stage is to develop and verify the effects of virtual natural environment on attention recovery and emotional recovery of institutional elders. The second stage is to evaluate the attention recovery and emotional effects of different types of virtual natural environments on institutional elders. The third stage is to test effects of the virtual natural environment intervention program improved attention, cognitive function, anxiety and depression in the institutionalized elders compared with the control group.
Detailed Description
This study is a third-stage project. The first stage is to explore the difference between real and virtual reality natural environment experiences on improving attention and emotion of elders. The one hundred and twenty participants will be randomly assigned to the experimental group (A group with actual experience of natural or B group with virtual reality experience of natural) and control group (actual experience of city). Outcome measures will include attention restoration, emotion, physiological measures, and virtual reality experience. The second stage is to explore the difference between tree element virtual natural environment and tree and water element virtual natural environment experiences on improving attention and emotion of older people. Participants will be randomly assigned to the experimental group (tree element group or tree and water element group) and control group (no intervention). Outcome measures will include attention restoration, emotion, physiological measures, and virtual reality experience. The third stage is to test effects of virtual reality natural environment intervention program on improving attention, cognitive function, anxiety and depression in institutional elderly. Eighty participants will be randomly assigned to the experimental group and control group. The intervention group will last for 8 weeks. Outcome measures will include attention, cognitive function, anxiety and depression, physiological measures, virtual reality e experience, sleep quality and activities of daily living. Contribution: This study aims to understand the effects of virtual natural environment intervention on the psychological symptoms and cognitive function of the elderly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older People
Keywords
Elders, Attention, Emotion, Cognitive function, natural environment, virtual reality, Mild cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This study has two stages. In stage 1, investigators will conduct a single-blinded, randomized controlled study for community elderly. One hundred and twenty participants will be randomly assigned to the two experimental group and the control group. In stage 2, investigators will conduct a crossover, single-blinded, randomized controlled study for institutionalized elderly. Forty participants will be randomly assigned to the two experimental group and the control group. In stage 3, investigators will conduct a single-blinded, randomized controlled study for institutionalized elderly. Eighty participants will be randomly assigned to the experimental group and the control group.
Masking
Outcomes Assessor
Masking Description
Stage 1:The data collection was carried out by a researcher who was blind to the intervention allocation, according to standard research guideline. Stage 2 and 3:Same as Stage 1
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 Experimental A group: Actual experience of nature environment
Arm Type
Experimental
Arm Description
actual natural environment
Arm Title
Stage 1 Experimental B group: virtual reality experience of nature environment
Arm Type
Experimental
Arm Description
virtual reality experience of nature environment
Arm Title
Stage 1 Control group: actual experience of city
Arm Type
Active Comparator
Arm Description
actual experience of city
Arm Title
Stage 2 group
Arm Type
Other
Arm Description
tree element virtual natural environment and tree and water element virtual natural environment experiences
Arm Title
Stage 3 Experimental group
Arm Type
Experimental
Arm Description
virtual reality experience of nature environment
Arm Title
Stage 3 Control group
Arm Type
Active Comparator
Arm Description
routine care
Intervention Type
Behavioral
Intervention Name(s)
Stage 1 Experimental A group: actual natural environment
Intervention Description
Participants will go to the park and sit still for 20 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Stage 1 Experimental B group: virtual reality natural environment
Intervention Description
Participants will experience the virtual reality natural environment by the researcher for 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
Stage 1 Control group: city environment
Intervention Description
Participants will sit still for 20 minutes in a city environment.
Intervention Type
Behavioral
Intervention Name(s)
Stage 2 group
Intervention Description
tree element virtual natural environment and tree and water element virtual natural environment experiences
Intervention Type
Behavioral
Intervention Name(s)
Stage 3 Experimental group: virtual reality natural environment
Intervention Description
virtual reality natural environment programs for 2 time a week (40 mins/ every week) and 8weeks.
Intervention Type
Behavioral
Intervention Name(s)
Stage 3 Control group: routine care
Intervention Description
Control group received routine care last for 8 weeks.
Primary Outcome Measure Information:
Title
Perceived Restorativeness Scale
Description
To measure attention Restoration.
Time Frame
1 week
Title
Digit span test
Description
To measure attention.
Time Frame
1 week, 8 weeks, 12 weeks
Title
Trail Making Test
Description
To measure attention.
Time Frame
1 week, 8 weeks, 12 weeks
Title
The Positive and Negative Affect Schedule
Description
To measure emotion.
Time Frame
1 week
Title
The Montreal Cognitive Assessment
Description
To measure Cognitive function.
Time Frame
1 week, 8 weeks, 12 weeks
Title
Depression, Anxiety and Stress Scale
Description
To measure short-term emotion
Time Frame
1 week, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Blood pressure, heart rate and heart rate variability
Description
measure the participant's sitting blood pressure, heartbeat and heart rate variability.
Time Frame
1week, 8 weeks, 12 weeks
Title
Qualitative experience
Description
At the end of the study, feelings about watching the virtual reality and suggestion
Time Frame
1week,8 weeks
Other Pre-specified Outcome Measures:
Title
Pittsburgh Sleep Quality Index
Description
To measure sleep status in the past month.
Time Frame
1 week, 8 weeks, 12 weeks
Title
The Barthel Index
Description
To measure daily living function
Time Frame
1 week, 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Stage 1 Inclusion Criteria: Age 65 years and older in Taipei City Cognitive function is normal (SPMSQ >8) The subjects can communicate in Chinese or Taiwanese. Exclusion criteria: Diseases affecting the results of the study, such as mental illness Vision or hearing problems Diseases transmitted by eyes or skin People with difficulty in walking. (The SPMSQ test was performed before the intervention to screen the cognitive function of the subjects). Stage 2 and 3 Inclusion Criteria: Age 65 years and older living in Institution for 6 months of more The subjects can communicate in Chinese or Taiwanese. Exclusion criteria: Diseases affecting the results of the study, such as mental illness Vision or hearing problems Diseases transmitted by eyes or skin People with dementia diagnosis or screening SPMSQ < 6 (The SPMSQ test was performed before the intervention to screen the cognitive function of the subjects).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Chen Chou, Ph.D
Phone
+886 2 28267000
Ext
7176
Email
chou8278@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Chen Chou, Ph.D
Organizational Affiliation
Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei, Taiwan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Feng
Email
fenghanti@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Explore the Effects of Virtual Reality Natural Environment of Older People

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