Explore the Effects of Virtual Reality Natural Environment of Older People

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Older People

Intervention / Treatment
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* Behavioral: Stage 1 Experimental A group: actual natural environment
* Behavioral: Stage 1 Experimental B group: virtual reality natural environment
* Behavioral: Stage 1 Control group: city environment
* Behavioral: Stage 2 group
* Behavioral: Stage 3 Experimental group: virtual reality natural environment
* Behavioral: Stage 3 Control group: routine care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1 Experimental A group: Actual experience of nature environment<br>actual natural environment | Behavioral: Stage 1 Experimental A group: actual natural environment<br>* Participants will go to the park and sit still for 20 minutes.<br>|
| Experimental: Stage 1 Experimental B group: virtual reality experience of nature environment<br>virtual reality experience of nature environment | Behavioral: Stage 1 Experimental B group: virtual reality natural environment<br>* Participants will experience the virtual reality natural environment by the researcher for 20 minutes<br>|
| Active Comparator: Stage 1 Control group: actual experience of city<br>actual experience of city | Behavioral: Stage 1 Control group: city environment<br>* Participants will sit still for 20 minutes in a city environment.<br>|
| Other: Stage 2 group<br>tree element virtual natural environment and tree and water element virtual natural environment experiences | Behavioral: Stage 2 group<br>* tree element virtual natural environment and tree and water element virtual natural environment experiences<br>|
| Experimental: Stage 3 Experimental group<br>virtual reality experience of nature environment | Behavioral: Stage 3 Experimental group: virtual reality natural environment<br>* virtual reality natural environment programs for 2 time a week (40 mins/ every week) and 8weeks.<br>|
| Active Comparator: Stage 3 Control group<br>routine care | Behavioral: Stage 3 Control group: routine care<br>* Control group received routine care last for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Restorativeness Scale | To measure attention Restoration. | 1 week | 
| Digit span test | To measure attention. | 1 week, 8 weeks, 12 weeks | 
| Trail Making Test | To measure attention. | 1 week, 8 weeks, 12 weeks | 
| The Positive and Negative Affect Schedule | To measure emotion. | 1 week | 
| The Montreal Cognitive Assessment | To measure Cognitive function. | 1 week, 8 weeks, 12 weeks | 
| Depression, Anxiety and Stress Scale | To measure short-term emotion | 1 week, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, heart rate and heart rate variability | measure the participant's sitting blood pressure, heartbeat and heart rate variability. | 1week, 8 weeks, 12 weeks | 
| Qualitative experience | At the end of the study, feelings about watching the virtual reality and suggestion | 1week,8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elders, Attention, Emotion, Cognitive function, natural environment, virtual reality, Mild cognitive impairment