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临床试验/NCT06682143
NCT06682143进行中(未招募)不适用

The Effects of Virtual Reality Greenspace Exposure on Physiological and Affective Acute Stress Responses Among Adults With Mobility Impairments: A Pilot Study

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
1
主要终点
Perceived Stress Scale (PSS)

研究概览

简要总结

The purpose of this project is to examine the effects of virtual reality greenspace exposure on physiological and affective acute stress responses among adults with mobility impairments.

详细描述

Exposure to greenspace is known to yield numerous mental and physical health benefits such as improved mood, decreased stress, and increased levels of physical activity. Regular access to greenspace however is difficult for various segments of the population including individuals with disabilities or chronic health conditions. Numerous factors contribute to this difficulty including architectural barriers, shortage of accessible trails, and limited transportation options. These challenges have led to a growing interest in exploring the use of virtual reality (VR) greenspace environments. Studies have demonstrated that VR greenspace exposure can reduce stress and improve mood and mental well-being in various populations but has not been tested among individuals with mobility impairments who experience high levels of stress. During a single lab visit, participants will be randomized to VR greenspace activity or control, undergo the Trier Social Stress Test. The VR group will then engage in a series of nature-based VR activities. The Control group will sit quietly. Assessments will be collected at 4 timepoints. Physiological stress responses will be measured via changes in BP, HR, and two saliva measures (salivary alpha-amylase, salivary cortisol). Affective response (stress, affect, anxiety) will be assessed using self-report surveys. This study will provide insight into the influence of VR greenspace exposure on stress recovery (physiological and affective responses), among individuals with mobility impairments.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 75 years
  • A self-reported lower extremity mobility impairment (e.g., cerebral palsy, spinal cord injury, multiple sclerosis, stroke) with partial or full use of the upper extremities.

排除标准

  • Impairment in visual acuity as measured by a Snellen eye chart <20/70 after correction
  • Regular engagement (>20 minutes/week) in virtual reality greenspace activity
  • Having an endocrine disorder (that can affect cortisol levels)
  • Taking oral corticosteroids
  • Score below 24 on the Mini Mental State Exam

研究组 & 干预措施

Virtual reality

Experimental

Participants will be outfitted with a virtual reality headset. While seated in a recliner chair, participants will engage in a pre-specified VR nature experience called Nature Treks VR for 5 minutes.

干预措施: Virtual Reality (VR) (Behavioral)

Control

Placebo Comparator

Participants will be seated in a recliner chair and asked to sit quietly for 5 minutes.

干预措施: Control (Behavioral)

结局指标

主要结局

Perceived Stress Scale (PSS)

时间窗: The survey will be completed at 4 timepoints: 1) Baseline (Stage 1) 2) Immediately after the Trier Social Stress Test (Stage 2); 3) Immediately following the VR or control activity; 4) 20 minutes after completion of the activity (VR or control).

The survey consists of 10 questions that assess the frequency of feelings and thoughts related to stress on a 5-point Likert scale (Never = 0, Almost never = 1, Sometimes = 2, Fairly often = 3; Very often = 4). To calculate a total PSS score, responses to the four positively stated items (items 4, 5, 7 and 8) first need to be reversed (i.e. 0 =\> 4; 1 =\> 3; 2 =\> 2; 3 =\> 1; 4 =\> 0). The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.

State-Trait Anxiety Inventory (STAI) short form

时间窗: The survey will be completed at 4 timepoints: 1) Baseline (Stage 1); 2) Immediately after the Trier Social Stress Test (Stage 2); 3) Immediately following the VR or control activity; 4) 20 minutes after completion of the activity (VR or control).

The 5-item short form of the State-Trait Anxiety Inventory (STAI) is designed to quickly assess anxiety levels. The questions measure state (temporary feelings of anxiety) and trait anxiety (general tendency to experience anxiety).The STAI short form is scored by summing the responses to each of the five items, which are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score can range from 5 to 20, with higher scores indicating higher levels of anxiety.

Positive and Negative Affect Schedule

时间窗: The survey will be completed at 4 timepoints: 1) Baseline (Stage 1); 2) Immediately after the Trier Social Stress Test (Stage 2); 3) Immediately following the VR or control activity; 4) 20 minutes after completion of the activity (VR or control).

The Positive and Negative Affect Schedule (PANAS) is designed to measure positive and negative affect. It consists of 20 items, with 10 items each for positive affect (PA) and negative affect (NA). Respondents rate each item on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). Positive Affect Score: Sum the scores of items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 to 50, with higher scores indicating higher levels of positive affect. Negative Affect Score: Sum the scores of items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 to 50, with higher scores indicating higher levels of negative affect.

Saliva stress biomarkers

时间窗: The saliva will be collected at 4 timepoints: 1) Baseline (Stage 1); 2) Immediately after the Trier Social Stress Test (Stage 2); 3) Immediately following the VR or control activity; 4) 20 minutes after completion of the activity (VR or control).

Saliva samples will be collected to measure stress biomarkers. The process is simple and non-invasive: Preparation: Participants should avoid eating, drinking (except water), brushing teeth, or using mouthwash for at least 30 minutes before sample collection. Collection: Participants will be provided with a sterile saliva collection device. They will be asked to spit into the device until it reaches the indicated fill line. Storage: The collected saliva samples will be stored in a cooler bag and then later transported to the UAB lab for storage and analyses.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurie A Malone, PhD

Associate Professor

University of Alabama at Birmingham

研究点 (1)

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