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临床试验/NCT06586489
NCT06586489已完成不适用

The Effects of Virtual Natural Environments in Improving Older Residents' Physical and Psychological Health in Long-term Care Facilities

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Depression

研究概览

简要总结

This randomized controlled trial aims to explore the impact of virtual natural environments on the mental and physical health of older adults in long-term care facilities. A total of 120 participants will be divided into 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 involves viewing virtual natural landscapes for 10 minutes, three times a week, over eight weeks. The study will evaluate the effectiveness of these virtual environments in enhancing the quality of life for elderly residents, with data collection occurring at multiple time points. Additionally, qualitative interviews will be conducted with VR group participants to capture their experiences and emotional responses.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 years or older
  • Residency in a long-term care institution for more than 1 month
  • Clear consciousness

排除标准

  • Blindness
  • Presence of an infectious disease
  • Inability to wear glasses

结局指标

主要结局

Depression

时间窗: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

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.

Level of Relaxation

时间窗: 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.

Temperature

时间窗: Immediately before and immediately after each intervention session.

Measurement of body temperature to monitor physiological changes. Unit of Measure: Degrees Celsius (°C)

Heart Rate

时间窗: Immediately before and immediately after each intervention session.

Measurement of heart rate to monitor physiological changes. Unit of Measure: Beats per minute (bpm)

Respiration Rate

时间窗: Immediately before and immediately after each intervention session.

Measurement of respiration rate to monitor physiological changes. Unit of Measure: Breaths per minute

Blood Pressure

时间窗: Immediately before and immediately after each intervention session.

Measurement of blood pressure to monitor physiological changes. Unit of Measure: Millimeters of mercury (mmHg)

Well-being

时间窗: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

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.

Heart Rate Variability (HRV)

时间窗: Immediately before and immediately after each intervention session

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

Emotion

时间窗: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

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.

Affect

时间窗: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

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.

Anxiety

时间窗: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

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.

Perceived Stress

时间窗: Baseline (pre-intervention), mid-intervention (week 4), end of intervention (week 8), and follow-up at one month post-intervention (week 12)

The Perceived Stress Scale (PSS-10) will be used to measure the residents perceived stress levels.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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