Critical IllnessVRICUNCT07482722
Virtual Reality-Based Transitional Care for ICU Survivors
A study testing Virtual Reality-Based Transitional Care in people with Critical Illness and Stress, Psychological, run by Mackay Memorial Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Illness, Stress, Psychological, Intensive Care Units
- What is being tested?
- Virtual Reality-Based Transitional Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTaiwan
- Study dates
- 9 Mar 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites
MacKay Memorial Hospital, Tamsui Branch
New Taipei City, 251
Yu-Ling Yang, RN, NP, +886-2-25433535, yihanurse@gmail.com
Te-Yu Wu, PhD
MacKay Memorial Hospital
Taipei, Taipei City, 104
About this study
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
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.
Read the 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.
- Being tested
- Virtual Reality-Based Transitional Care
- Keywords
- Virtual Reality, ICU Survivors, Relocation Stress, Heart Rate Variability, Transitional Care, Unplanned ICU Readmission, Randomized Controlled Trial
- Medical subject headings
- Critical Illness, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Transitional CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention Group | Experimental | Participants receive standard transitional care plus three VR sessions during ICU stay. Receives: Behavioral: Virtual Reality-Based Transitional Care |
| Standard Care Group | No intervention | Participants receive standard ICU transitional care without VR intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability - RMSSD
Heart rate variability measured using the Root Mean Square of Successive Differences (RMSSD) derived from electrocardiographic recordings.
Measured: 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.
Measured: Within 48 hours after transfer from the ICU to the general ward
Secondary outcomes (3)
Pain Intensity
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.
Measured: Within 48 hours after ICU transfer
Unplanned ICU Readmission
Occurrence of unplanned readmission to the ICU within 7 days after transfer to the general ward.
Measured: Within 7 days after ICU transfer
Relocation Stress
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.
Measured: Within 48 hours after ICU transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start9 Mar 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Te-Yu Wu, Mackay Memorial Hospital
- Investigators
- Te-Yu Wu, PhD, Principal investigator, MacKay Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482722
- Sponsor's protocol ID
- 24MMHIS535e
- Acronym
- VRICU
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07482722
- Acronym / sponsor ID
- VRICU / 24MMHIS535e
- Keywords
- Virtual Reality, ICU Survivors, Relocation Stress, Heart Rate Variability, Transitional Care, Unplanned ICU Readmission, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Intervention Group | Experimental | Behavioral: Virtual Reality-Based Transitional CareParticipants receive standard transitional care plus three VR sessions during ICU stay. |
| Standard Care Group | No intervention | –Participants receive standard ICU transitional care without VR intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based Transitional CareParticipants 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. | Behavioural | VR Intervention Group |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Te-Yu Wu, PhD principal investigator
MacKay Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Transitional Care in people with Critical Illness and Stress, Psychological, run by Mackay Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ling Yang, RN, NP (+886-2-25433535, yihannurse@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability - RMSSD (time frame: Within 48 hours after transfer from the ICU to the general ward). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.