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

NCT ID: NCT06797895

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2027-03-31

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).

Detailed Description

Patients who survive critical illness and prolonged intensive care unit (ICU) stays are at risk for debilitating physical (deconditioning, skin injury, and infection), and mental health impairment (depression, anxiety and PTSD). Early mobility improves these deleterious outcomes but is challenging to implement in patients on prolonged bedrest. The purpose of this study is to compare a nurse-led implementation of a Virtual Reality (VR) experience in the Cardio-Thoracic Intensive Care Unit (CT-ICU) to standard of care to improve mobility for patients on prolonged bedrest. The investigators hypothesize that nurse-led implementation of VR experiences in the CT-ICU, in combination with engineering-led patient-centered customization of the VR applications, will improve both the physical and psychological function of ICU patients on prolonged bedrest.

Conditions

Mobility; ICU; Heart Surgery; Nursing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality (VR) intervention

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

Group Type: OTHER

VR assisted mobility

Intervention Type: BEHAVIORAL

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

Interventions

VR assisted mobility

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna E Mall, MSN

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Hospital

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna E Mall, MSN

Role: CONTACT

anna.mall@duke.edu

984-227-0106

Facility Contacts

Anna Mall

Role: primary

anna.mall@duke.edu

984-227-0106

Other Identifiers

PRO00116448

Identifier Type: -

Identifier Source: org_study_id