Clinical trial NCT05803460: 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
Overall status: RECRUITING
Phase: NA
Conditions: Older People
Keywords: Elders
Attention
Emotion
Cognitive function
natural environment
virtual reality
Mild cognitive impairment
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Perceived Restorativeness Scale
timeFrame: 1 week
measure: Digit span test
timeFrame: 1 week, 8 weeks, 12 weeks
measure: Trail Making Test
timeFrame: 1 week, 8 weeks, 12 weeks
measure: The Positive and Negative Affect Schedule
timeFrame: 1 week
measure: The Montreal Cognitive Assessment
timeFrame: 1 week, 8 weeks, 12 weeks
measure: Depression, Anxiety and Stress Scale
timeFrame: 1 week, 8 weeks, 12 weeks
Secondary outcomes:
measure: Blood pressure, heart rate and heart rate variability
timeFrame: 1week, 8 weeks, 12 weeks
measure: Qualitative experience
timeFrame: 1week,8 weeks
Other outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 week, 8 weeks, 12 weeks
measure: The Barthel Index
timeFrame: 1 week, 8 weeks, 12 weeks
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: Nursing
name: Cheng-Chen Chou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: