DeliriumNCT05525702
VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
A study testing VRFS in people with Delirium, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the effect of Virtual Reality Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is: ·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes?… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delirium
- What is being tested?
- VRFS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2023to 31 Dec 2026
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation duration is expected to be greater than 24 hours;
- ICU stay duration is expected to be greater than 72 hours;
- Age is 18 years or older, with no upper age limit;
- Language: Chinese. Exclusion Criteria
- Severe visual or auditory impairments (diplopia, low vision due to macular degeneration, retinopathy; severe hearing loss or deafness);
- Cognitive and consciousness disturbances prior to ICU admission;
Show all 9Show fewer
- Severe motion sickness;
- Head trauma or surgery that prevents the wearing of equipment;
- A history of long-term use of antipsychotic and/or benzodiazepine medications.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
PUMC
Beijing, Beijing Municipality, 100730
Yingying Yang, MD, +8618800173833, yangyingying2703@outlook.com
About this study
Official title: Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients With Mechanical Ventilation
The goal of this clinical trial is to learn the effect of Virtual Reality Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is:
·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes?
Read more
Researchers will investigate whether the implementation of VRFS can reduce the number of delirium days and improve clinical outcomes.
Participants will:
- Receive the VRFS intervention until the endotracheal tube (ETT) is removed.
- Have physiological data collected, including EEG, oxygen saturation levels, ECG, and blood pressure.
- Keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and ICU stays.
Read the detailed description
During the VRFS interventions, researchers will fit participants with a VR headset and noise-canceling headphones, shielding them from the ICU environment while allowing family members to be present and offer companionship and comfort.
- Conditions
- Delirium
- Being tested
- VRFS
- Keywords
- ICU, Virtual Reality, Delirium, family support
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRFSDevice
Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.
| Study group | Role | What they receive |
|---|---|---|
| VRFS Intervention | Experimental | Participants will receive standard ICU care and will also undergo VRFS intervention. Receives: Device: VRFS |
| Standard ICU Care | No intervention | Patients will be treated with standard ICU care and not receive VR stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Day
Delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items ((1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking) and each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive.
Measured: Twice daily from Day 1 through ICU discharge, an average of 7 days.
Secondary outcomes (5)
ICU Days
The ICU stays are daily recorded by the physicians and nurses in ICU.
Measured: From ICU admission through ICU discharge, an average of 7 days.
Duration of Mechanical Ventilation
The duration of mechanical ventilation is daily recorded by the physicians and nurses.
Measured: From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.
Dosage of sedative and analgesic drugs
Daily records by doctors and nurses.
Measured: Daily from Day 1 through ICU discharge, an average of 7 days.
Incidence of Delirium
The proportion of participants who experience at least one CAM-ICU-positive episode during their ICU stay, assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Measured: Twice daily from Day 1 through ICU discharge, an average of 7 days.
Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)
Family satisfaction is assessed using the FS-ICU scale, evaluating satisfaction with nursing care (FS-Care) and the decision-making process (FS-DM). The results include the total score (FS-Total) and two subscale scores (FS-Care and FS-DM).
Measured: At baseline (Day 0) and within 3 days after ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start18 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Study director, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525702
- Sponsor's protocol ID
- K4774
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nassar Junior AP, Besen BAMP, Robinson CC, Falavigna M, Teixeira C, Rosa RG. Flexible Versus Restrictive Visiting Policies in ICUs: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 Jul;46(7):1175-1180. doi: 10.1097/CCM.0000000000003155.
PubMed 29642108da Silva Ramos FJ, Fumis RR, Azevedo LC, Schettino G. Perceptions of an open visitation policy by intensive care unit workers. Ann Intensive Care. 2013 Oct 17;3(1):34. doi: 10.1186/2110-5820-3-34.
PubMed 24135292Mohsen S, Moss SJ, Lucini F, Krewulak KD, Stelfox HT, Niven DJ, Sauro KM, Fiest KM. Impact of Family Presence on Delirium in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Med. 2022 Nov 1;50(11):1628-1637. doi: 10.1097/CCM.0000000000005657. Epub 2022 Aug 26.
PubMed 36044306Deng LX, Cao L, Zhang LN, Peng XB, Zhang L. Non-pharmacological interventions to reduce the incidence and duration of delirium in critically ill patients: A systematic review and network meta-analysis. J Crit Care. 2020 Dec;60:241-248. doi: 10.1016/j.jcrc.2020.08.019. Epub 2020 Aug 31.
PubMed 32919363Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
PubMed 24088092van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
PubMed 21926597Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Mehta S, Cook D, Devlin JW, Skrobik Y, Meade M, Fergusson D, Herridge M, Steinberg M, Granton J, Ferguson N, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Mallick R, Reynolds S, Keenan S, Burry L; SLEAP Investigators; Canadian Critical Care Trials Group. Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Crit Care Med. 2015 Mar;43(3):557-66. doi: 10.1097/CCM.0000000000000727.
PubMed 25493968Wiegand TLT, Remi J, Dimitriadis K. Electroencephalography in delirium assessment: a scoping review. BMC Neurol. 2022 Mar 11;22(1):86. doi: 10.1186/s12883-022-02557-w.
PubMed 35277128Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.
PubMed 21092264Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.
PubMed 31354253Chen H, Mo L, Hu H, Ou Y, Luo J. Risk factors of postoperative delirium after cardiac surgery: a meta-analysis. J Cardiothorac Surg. 2021 Apr 26;16(1):113. doi: 10.1186/s13019-021-01496-w.
PubMed 33902644Thom RP, Levy-Carrick NC, Bui M, Silbersweig D. Delirium. Am J Psychiatry. 2019 Oct 1;176(10):785-793. doi: 10.1176/appi.ajp.2018.18070893. No abstract available.
PubMed 31569986
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05525702
- Acronym / sponsor ID
- K4774
- Conditions
- Delirium
- Keywords
- ICU, Virtual Reality, Delirium, family support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Sep 2022 (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.
The goal of this clinical trial is to learn the effect of Virtual Reality Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is:
·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes?
Researchers will investigate whether the implementation of VRFS can reduce the number of delirium days and improve clinical outcomes.
Participants will:
- Receive the VRFS intervention until the endotracheal tube (ETT) is removed.
- Have physiological data collected, including EEG, oxygen saturation levels, ECG, and blood pressure.
- Keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and ICU stays.
Detailed description
During the VRFS interventions, researchers will fit participants with a VR headset and noise-canceling headphones, shielding them from the ICU environment while allowing family members to be present and offer companionship and comfort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRFS Intervention | Experimental | Device: VRFSParticipants will receive standard ICU care and will also undergo VRFS intervention. |
| Standard ICU Care | No intervention | –Patients will be treated with standard ICU care and not receive VR stimulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Mechanical ventilation duration is expected to be greater than 24 hours;
- ICU stay duration is expected to be greater than 72 hours;
- Age is 18 years or older, with no upper age limit;
- Language: Chinese. Exclusion Criteria
- Severe visual or auditory impairments (diplopia, low vision due to macular degeneration, retinopathy; severe hearing loss or deafness);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VRFSParticipants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort. | Device | VRFS Intervention |
Primary outcome
Delirium Day
Time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.
Delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items ((1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking) and each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive.
5 secondary outcomes
ICU Days
Time frame: From ICU admission through ICU discharge, an average of 7 days.
Duration of Mechanical Ventilation
Time frame: From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.
Dosage of sedative and analgesic drugs
Time frame: Daily from Day 1 through ICU discharge, an average of 7 days.
Incidence of Delirium
Time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.
Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)
Time frame: At baseline (Day 0) and within 3 days after ICU discharge.
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 27 Mar 2026.
- Background: PubMed 29642108Nassar Junior AP, Besen BAMP, Robinson CC, Falavigna M, Teixeira C, Rosa RG. Flexible Versus Restrictive Visiting Policies in ICUs: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 Jul;46(7):1175-1180. doi: 10.1097/CCM.0000000000003155.
- Background: PubMed 24135292da Silva Ramos FJ, Fumis RR, Azevedo LC, Schettino G. Perceptions of an open visitation policy by intensive care unit workers. Ann Intensive Care. 2013 Oct 17;3(1):34. doi: 10.1186/2110-5820-3-34.
- Background: PubMed 36044306Mohsen S, Moss SJ, Lucini F, Krewulak KD, Stelfox HT, Niven DJ, Sauro KM, Fiest KM. Impact of Family Presence on Delirium in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Med. 2022 Nov 1;50(11):1628-1637. doi: 10.1097/CCM.0000000000005657. Epub 2022 Aug 26.
- Background: PubMed 32919363Deng LX, Cao L, Zhang LN, Peng XB, Zhang L. Non-pharmacological interventions to reduce the incidence and duration of delirium in critically ill patients: A systematic review and network meta-analysis. J Crit Care. 2020 Dec;60:241-248. doi: 10.1016/j.jcrc.2020.08.019. Epub 2020 Aug 31.
- Background: PubMed 24088092Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
- Background: PubMed 21926597van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 25493968Mehta S, Cook D, Devlin JW, Skrobik Y, Meade M, Fergusson D, Herridge M, Steinberg M, Granton J, Ferguson N, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Mallick R, Reynolds S, Keenan S, Burry L; SLEAP Investigators; Canadian Critical Care Trials Group. Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Crit Care Med. 2015 Mar;43(3):557-66. doi: 10.1097/CCM.0000000000000727.
- Background: PubMed 35277128Wiegand TLT, Remi J, Dimitriadis K. Electroencephalography in delirium assessment: a scoping review. BMC Neurol. 2022 Mar 11;22(1):86. doi: 10.1186/s12883-022-02557-w.
- Background: PubMed 21092264Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.
- Background: PubMed 31354253Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.
- Background: PubMed 33902644Chen H, Mo L, Hu H, Ou Y, Luo J. Risk factors of postoperative delirium after cardiac surgery: a meta-analysis. J Cardiothorac Surg. 2021 Apr 26;16(1):113. doi: 10.1186/s13019-021-01496-w.
- Individual participant dataSharing planned: No
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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.
Yun Long, MD study director
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRFS in people with Delirium, run by Peking Union Medical College Hospital at 1 site in China.
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 9 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 27 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 1 site in China. 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 Yingying Yang, MD (+8618800173833, yangyingying2703@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium Day (time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525702, which also lists 13 linked publications.
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 27 Mar 2026.