Explore the Effects of Virtual Reality Natural Environment of Older People

Older People Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803460
• Other study ID #: YM111067E
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2023
• Source: National Yang Ming University
• Contact: Cheng-Chen Chou, Ph.D
• Phone: +886 2 28267000
• Email: chou8278[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Stage 1

Inclusion Criteria:

1. Age 65 years and older in Taipei City

2. Cognitive function is normal (SPMSQ >8)

3. The subjects can communicate in Chinese or Taiwanese.

Exclusion criteria:

1. Diseases affecting the results of the study, such as mental illness

2. Vision or hearing problems

3. Diseases transmitted by eyes or skin

4. 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:

1. Age 65 years and older

2. living in Institution for 6 months of more

3. The subjects can communicate in Chinese or Taiwanese.

Exclusion criteria:

1. Diseases affecting the results of the study, such as mental illness

2. Vision or hearing problems

3. Diseases transmitted by eyes or skin

4. People with dementia diagnosis or screening SPMSQ < 6 (The SPMSQ test was performed before the intervention to screen the cognitive function of the subjects).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Older People

Intervention

Behavioral:
• Stage 1 Experimental A group: actual natural environment
Participants will go to the park and sit still for 20 minutes.
• Stage 1 Experimental B group: virtual reality natural environment
Participants will experience the virtual reality natural environment by the researcher for 20 minutes
• Stage 1 Control group: city environment
Participants will sit still for 20 minutes in a city environment.
• Stage 2 group
tree element virtual natural environment and tree and water element virtual natural environment experiences
• Stage 3 Experimental group: virtual reality natural environment
virtual reality natural environment programs for 2 time a week (40 mins/ every week) and 8weeks.
• Stage 3 Control group: routine care
Control group received routine care last for 8 weeks.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh Sleep Quality Index	To measure sleep status in the past month.	1 week, 8 weeks, 12 weeks
Other	The Barthel Index	To measure daily living function	1 week, 8 weeks, 12 weeks
Primary	Perceived Restorativeness Scale	To measure attention Restoration.	1 week
Primary	Digit span test	To measure attention.	1 week, 8 weeks, 12 weeks
Primary	Trail Making Test	To measure attention.	1 week, 8 weeks, 12 weeks
Primary	The Positive and Negative Affect Schedule	To measure emotion.	1 week
Primary	The Montreal Cognitive Assessment	To measure Cognitive function.	1 week, 8 weeks, 12 weeks
Primary	Depression, Anxiety and Stress Scale	To measure short-term emotion	1 week, 8 weeks, 12 weeks
Secondary	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
Secondary	Qualitative experience	At the end of the study, feelings about watching the virtual reality and suggestion	1week,8 weeks