VR Collaboration System to Improve Mental Health Outcomes

NCT ID: NCT05773131

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 566 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2024-03-17

Brief Summary

Collaboration between family members and mechanically ventilated (MV) patients in the intensive care unit (ICU) is essential for improving patients' hospitalization experiences and outcomes. However, numerous hospitals have reduced the visiting time and frequency in ICUs due to the global spread of SARS-CoV-2 in recent years, aggravating mental problems and reducing the satisfaction of ICU patients and their families. Therefore, we propose an effective intervention strategy to enhance patient-family bonding and improve patient mental health and ICU experience by constructing a remote cross-platform virtual reality collaboration system (VRCS) for connecting family members at home with patients in the ICU. We aim to assess the effects of VRCS on the mental health of ICU patients.

Detailed Description

Introduction: The ICU is a specialized medical unit equipped with state-of-the-art monitoring equipment and life support machines to provide care for critically ill patients. Patients in the ICU receive extensive and dynamic monitoring to ensure the timely and effective treatment to reduce mortality rates. However, despite the benefits of ICU care, patients may experience severe mental distress and poor hospital experiences due to a variety of factors. In fact, studies have shown that a majority of ICU patients (over 60%) experience long-lasting psychological problems. Current studies have shown that involving families in the care process can help patients feel more secure and lead to greater satisfaction among patients and their families. But due to nosocomial infection, most ICUs still adopt a restrictive visiting strategy. Therefore, we propose a virtual visiting method based on a remote cross-platform VR collaboration system (VRCS) to help patients get rid of the stressful ICU environments, and provide real-time interaction and communication between patients and their families, so as to improve the mental health and hospitalization experience of patients, as well as improve the satisfaction of patients and families.

Methods and Materials: This single-blind, randomized, controlled trial will be conducted from January to December 2023 in the ICU of Peking Union Medical College Hospital (PUMCH). We aim to randomize 566 adult ICU patients with an expected mechanical ventilation time over 24 hours into the VRCS intervention group and the control group (283 in each group). The patients in the VRCS group can see their families in a virtual natural forest environment through VR headsets and communicate with them through an eye-tracking interaction method. Simultaneously, their family members can see and communicate with the patients through smartphones, computers, or TVs at home. The primary objective is to study the effect of VRCS on the mental health and hospitalization experience of MV patients during the ICU stay. The secondary outcome is to assess the effect of VRCS on the incidence of delirium and the quality of patient-family communication during hospitalization.

Conditions

Mental Health Issue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR collaborative visualization group

In this intervention system, the stimulation materials, communication interface, collaboration tasks, and immersive 360-degree scenario will be played inside a commercially available head-mounted display on the patient side, as well as these materials will be played in the smartphone on the family members' side.

Group Type: EXPERIMENTAL

VR collaborative visualization system

Intervention Type: DEVICE

Patients wear virtual reality head-mounted displays while family members using smart phones to interact in a same virtual space.

Standard ICU Care

Patients will be treated with standard ICU care and not receive VR stimulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VR collaborative visualization system

Patients wear virtual reality head-mounted displays while family members using smart phones to interact in a same virtual space.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Mechanical ventilation time > 24h, and is currently undergoing mechanical ventilation;
• Age ≥ 18 years old, no upper age limit;
• Language: Chinese;
• RAAS score ≥ -2 points;
• Hemodynamic stability.

Exclusion Criteria

• Severe visual impairment (WHO classification: severe visual impairment) or hearing impairment (WHO classification: severe hearing loss);
• Cognitive and consciousness impairment;
• Head trauma or surgery resulting in an inability to wear HMDs.

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

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun Long, MD

Role: STUDY_DIRECTOR

Peking Union Medical College

Locations

PUMC

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingying Yang, MD

Role: CONTACT

yangyingying2703@outlook.com

+8618800173833

Facility Contacts

Yingying Yang, MD

Role: primary

yangyingying2703@outlook.com

+8618800173833

Other Identifiers

JS-3575-1

Identifier Type: -

Identifier Source: org_study_id