Clinical trial NCT05773131: VR Collaboration System to Improve Mental Health Outcomes
Official title: Remote Cross-Platform VR Collaboration System for Mechanically Ventilated ICU Patients to Improve Mental Health Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Keywords: ICU
mechanically ventilated patients
virtual reality
mental health
social connection
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure
timeFrame: 1 year
measure: Heart Rate
timeFrame: 1 year
measure: Respiratory rate
timeFrame: 1 year
measure: Oxygen saturation level
timeFrame: 1 year
measure: Activation of cranial nerve signals
timeFrame: 1 year
measure: Number of Acute Cardiac Events
timeFrame: 1 year
measure: Duration of Mechanical Ventilation
timeFrame: 1 year
measure: ICU Days
timeFrame: 1 year
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 1 year
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 1 year
measure: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
timeFrame: 1 year
measure: Family In-Patient Communication Survey (FICS)
timeFrame: 1 year
measure: Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: PUMC
state: Beijing
Study officials:
affiliation: Peking Union Medical College
name: Yun Long, MD
role: STUDY_DIRECTOR
References: