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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mackay Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings