Virtual Reality-Based Transitional Care for ICU Survivors (VRICU)

March 16, 2026 updated by: Te-Yu Wu, Mackay Memorial Hospital

Impact of a Virtual Reality-Based Transitional Care Program on Heart Rate Variability, Pain, Relocation Stress, and Unplanned ICU Readmission Among Adult ICU Survivors: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, randomized controlled trial designed to investigate the effects of a virtual reality (VR)-based transitional care intervention on physiological stability and psychological adaptation among adult ICU survivors.

Critically ill patients often experience relocation stress syndrome following transfer from the ICU to general wards. This transition period is associated with increased anxiety, pain perception, autonomic imbalance, and a higher risk of unplanned ICU readmission.

Eligible participants will be randomized using block randomization into the intervention or control group. The intervention group will receive three VR sessions during their ICU stay in addition to standard transitional care. The control group will receive standard care alone.

The primary outcome is short-term physiological stability measured within 48 hours after ICU transfer. Secondary outcomes include heart rate variability parameters, pain intensity, relocation stress, and unplanned ICU readmission within 7 days.

This study seeks to determine whether VR-assisted transitional care can enhance recovery, reduce stress-related responses, and improve patient outcomes following ICU discharge.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 251
        • MacKay Memorial Hospital, Tamsui Branch
        • Contact:
        • Contact:
          • Te-Yu Wu, PhD
    • Taipei City
      • Taipei, Taipei City, Taiwan, 104
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR Intervention Group
Participants receive standard transitional care plus three VR sessions during ICU stay.
Behavioral: Virtual Reality-Based Transitional Care
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.
No Intervention: Standard Care Group
Participants receive standard ICU transitional care without VR intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability - RMSSD
Time Frame: Within 48 hours after transfer from the ICU to the general ward
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
Time Frame: Within 48 hours after transfer from the ICU to the general ward
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Within 48 hours after ICU transfer
Pain intensity will be assessed using the Defense and Veterans Pain Rating Scale (DVPRS), a numeric rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Within 48 hours after ICU transfer
Unplanned ICU Readmission
Time Frame: Within 7 days after ICU transfer
Occurrence of unplanned readmission to the ICU within 7 days after transfer to the general ward.
Within 7 days after ICU transfer
Relocation Stress
Time Frame: Within 48 hours after ICU transfer
Relocation stress will be assessed using the Relocation Stress Syndrome Scale - Short Form (RSSS-SF). The scale consists of items rated on a Likert scale, with higher scores indicating greater relocation stress.
Within 48 hours after ICU transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Te-Yu Wu, PhD, MacKay Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 9, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24MMHIS535e

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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