VR Collaboration System to Improve Mental Health Outcomes

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Mental Health Issue

Treatments: Device: VR collaborative visualization system

Study type: Interventional

Funder types: Other

Identifiers

NCT05773131

JS-3575-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 566 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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566 participants in 2 patient groups

VR collaborative visualization group

Experimental group

Description:

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.

Treatment:

Device: VR collaborative visualization system

Standard ICU Care

No Intervention group

Description:

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