Virtual Reality-Based Transitional Care for ICU Survivors

NCT07482722 | Not Yet Recruiting

• 1 other identifier: 24MMHIS535e
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effectiveness of a virtual reality (VR)-based transitional care program for adult survivors of intensive care unit (ICU) care. ICU survivors frequently experience relocation stress, anxiety, pain, and physiological instability after transfer from the ICU to general wards, which may increase the risk of unplanned ICU readmission. Participants will be randomly assigned to receive either standard transitional care or additional VR-based intervention sessions during their ICU stay. The VR intervention is designed to provide psychological support, environmental orientation, and stress reduction. Primary outcomes include short-term physiological indicators within 48 hours after ICU transfer. Secondary outcomes include pain, relocation stress, and unplanned ICU readmission within 7 days.

Conditions

Critical Illness; Stress, Psychological; Intensive Care Units

Keywords

Virtual Reality; ICU Survivors; Relocation Stress; Heart Rate Variability; Transitional Care; Unplanned ICU Readmission; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability - RMSSD

  Heart rate variability measured using the Root Mean Square of Successive Differences (RMSSD) derived from electrocardiographic recordings.

  Within 48 hours after transfer from the ICU to the general ward

• Heart Rate Variability - High Frequency Power

  Heart rate variability measured using high-frequency (HF) power derived from electrocardiographic recordings.

  Within 48 hours after transfer from the ICU to the general ward

Secondary Outcomes (3)

• Pain Intensity

  Within 48 hours after ICU transfer

• Unplanned ICU Readmission

  Within 7 days after ICU transfer

• Relocation Stress

  Within 48 hours after ICU transfer

Study Arms (2)

VR Intervention Group

EXPERIMENTAL

Participants receive standard transitional care plus three VR sessions during ICU stay.

Behavioral: Virtual Reality-Based Transitional Care

Standard Care Group

NO INTERVENTION

Participants receive standard ICU transitional care without VR intervention.

Interventions

Virtual Reality-Based Transitional Care BEHAVIORAL

Participants assigned to this arm will receive three structured virtual reality (VR) sessions during their ICU stay in addition to standard transitional care. Each VR session is designed to provide environmental orientation, psychological support, and stress reduction through immersive audiovisual content. The intervention aims to improve short-term physiological stability and reduce relocation stress following ICU transfer.

VR Intervention Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years or older
• Adult patients admitted to the intensive care unit (ICU)
• Planned transfer from ICU to the general ward
• Able to communicate and provide informed consent or have a legal representative provide consent

You may not qualify if:

• Severe cognitive impairment or delirium preventing participation
• Severe visual or hearing impairment interfering with VR use
• Hemodynamic instability requiring immediate life-saving intervention
• Isolation precautions prohibiting device use
• Participation in another interventional study that may affect outcomes

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (2)

MacKay Memorial Hospital

Taipei, Taipei City, 104, Taiwan

Location

MacKay Memorial Hospital, Tamsui Branch

New Taipei City, 251, Taiwan

Location

MeSH Terms

Conditions

Critical Illness; Stress, Psychological

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Te-Yu Wu, PhD

  MacKay Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Ling Yang, RN, NP

CONTACT

+886-2-25433535; yihannurse@gmail.com

Yu-Ling Yang, RN, NP

CONTACT

+886-2-25433535; yihanurse@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MacKay Medical University

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the VR intervention group or the standard care control group using block randomization.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 19, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

TW (2)