VR Collaboration System to Improve Mental Health Outcomes

NCT05773131 | Unknown DMC

• 1 other identifier: JS-3575-1
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Keywords

ICU; mechanically ventilated patients; virtual reality; mental health; social connection

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  The HADS is designed by Zigmond and Snaith in 1983 to assess anxiety and depression symptoms in medical patients, including 14 items and every item scoring from 1 to 4. It includes two scales, one for anxiety (HADS-A) and another for depression (HADS-D). Each scale has 7 items and has a total score range from 7 to 28. The diagnostic criteria are that if the diagnosed person scores more than 11 points on any scale, it can be regarded as a confirmed case.

  1 year

Secondary Outcomes (13)

• Blood pressure

  1 year

• Heart Rate

  1 year

• Respiratory rate

  1 year

• Oxygen saturation level

  1 year

• Activation of cranial nerve signals

  1 year

Study Arms (2)

VR collaborative visualization group

EXPERIMENTAL

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.

Device: VR collaborative visualization system

Standard ICU Care

NO INTERVENTION

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

Interventions

VR collaborative visualization system DEVICE

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

VR collaborative visualization group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

PUMC

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Yun Long, MD

  Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Yingying Yang, MD

CONTACT

+8618800173833; yangyingying2703@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: March 7, 2023
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: March 17, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)