NCT06682143

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

October 22, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

October 22, 2024

Last Update Submit

April 29, 2025

Conditions

Keywords

stressmobility impairmentvirtual realitygreenspace

Outcome Measures

Primary Outcomes (4)

  • Perceived Stress Scale (PSS)

    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.

    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).

  • State-Trait Anxiety Inventory (STAI) short form

    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.

    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).

  • Positive and Negative Affect Schedule

    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.

    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).

  • Saliva stress biomarkers

    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.

    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).

Study Arms (2)

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.

Behavioral: Virtual Reality (VR)

Control

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

Participants will engage in a virtual reality greenspace activity for a period of 5 minutes

Virtual reality
ControlBEHAVIORAL

Participants will sit quietly for a period of 5 minutes

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Central Study Contacts

Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2024

First Posted

November 12, 2024

Study Start

April 7, 2025

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

This is a pilot study so IPD will not be shared.

Locations