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Not yet recruiting NCT07482722

Virtual Reality-Based Transitional Care for ICU Survivors

No phase Interventional Critical Illness Stress, Psychological Intensive Care Units

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality-Based Transitional Care.
Who it may be relevant to
Registry conditions: Critical Illness, Stress, Psychological, Intensive Care Units. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Heart Rate Variability - RMSSD [Time frame: 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]
Secondary outcome measures (3)
  • Pain Intensity [Time frame: Within 48 hours after ICU transfer]
  • Unplanned ICU Readmission [Time frame: Within 7 days after ICU transfer]
  • Relocation Stress [Time frame: Within 48 hours after ICU transfer]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • MacKay Memorial Hospital — Taipei
  • MacKay Memorial Hospital, Tamsui Branch — New Taipei City

Identifiers

NCT: NCT07482722 · 24MMHIS535e

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗