Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units

NCT06797895 | Active Not Recruiting

• 1 other identifier: PRO00116448
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).

Conditions

Mobility; ICU; Heart Surgery; Nursing

Outcome Measures

Primary Outcomes (1)

• Feasibility as measured by nursing time required

  For each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.

  up to 6 months

Secondary Outcomes (10)

• Usability as measured by patient-reported ease of playing the game

  up to 6 months

• Usability as measured by patient-reported ease of hand controller use

  up to 6 months

• Usability as measured by patient-reported wearability of headset

  up to 6 months

• Usability as measured by patient-reported comfort of headset

  up to 6 months

• Number of participants who find the intervention acceptable

  up to 6 months

Other Outcomes (2)

• Change in BDNF (brain-derived neurotrophic factor) level

  Baseline to day 10 or ICU transfer, whichever comes first

• Change in TNF (tumor necrosis factor) level

  Baseline to day 10 or ICU transfer, whichever comes first

Study Arms (1)

Virtual Reality (VR) intervention

OTHER

Cohort for observing the effects of the VR intervention on ICU mobility.

Behavioral: VR assisted mobility

Interventions

VR assisted mobility BEHAVIORAL

Commercially-based VR experience used to help move upper extremities to music, similar to dancing or Tai-Chi.

Virtual Reality (VR) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• English speaking
• + days ICU admission with limited mobility

You may not qualify if:

• Pregnancy
• Blind/severe visual impairment
• History of seizures
• Intubation/sedation
• Special enteric contact isolation

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Study Officials

• Anna E Mall, MSN

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 29, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)