Mental Health IssueNCT05773131
VR Collaboration System to Improve Mental Health Outcomes
A study testing VR collaborative visualization system in people with Mental Health Issue, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Collaboration between family members and mechanically ventilated (MV) patients in the intensive care unit (ICU) is essential for improving patients' hospitalization experiences and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- VR collaborative visualization system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2023to 17 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation time > 24h, and is currently undergoing mechanical ventilation;
- Age ≥ 18 years old, no upper age limit;
- Language: Chinese;
- RAAS score ≥ -2 points;
- Hemodynamic stability.
Who cannot join
- Severe visual impairment (WHO classification: severe visual impairment) or hearing impairment (WHO classification: severe hearing loss);
- Cognitive and consciousness impairment;
- Head trauma or surgery resulting in an inability to wear HMDs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PUMC
Beijing, Beijing Municipality, 100730
Yingying Yang, MD, +8618800173833, yangyingying2703@outlook.com
About this study
Official title: Remote Cross-Platform VR Collaboration System for Mechanically Ventilated ICU Patients to Improve Mental Health Outcomes
Collaboration between family members and mechanically ventilated (MV) patients in the intensive care unit (ICU) is essential for improving patients' hospitalization experiences and outcomes. However, numerous hospitals have reduced the visiting time and frequency in ICUs due to the global spread of SARS-CoV-2 in recent years, aggravating mental problems and reducing the satisfaction of ICU patients and their families. Therefore, we propose an effective intervention strategy to enhance patient-family bonding and improve patient mental health and ICU experience by constructing a remote cross-platform virtual reality collaboration system (VRCS) for connecting family members at home with patients in the ICU. We aim to assess the effects of VRCS on the mental health of ICU patients.
Read the detailed description
Introduction: The ICU is a specialized medical unit equipped with state-of-the-art monitoring equipment and life support machines to provide care for critically ill patients. Patients in the ICU receive extensive and dynamic monitoring to ensure the timely and effective treatment to reduce mortality rates. However, despite the benefits of ICU care, patients may experience severe mental distress and poor hospital experiences due to a variety of factors. In fact, studies have shown that a majority of ICU patients (over 60%) experience long-lasting psychological problems. Current studies have shown that involving families in the care process can help patients feel more secure and lead to greater satisfaction among patients and their families. But due to nosocomial infection, most ICUs still adopt a restrictive visiting strategy. Therefore, we propose a virtual visiting method based on a remote cross-platform VR collaboration system (VRCS) to help patients get rid of the stressful ICU environments, and provide real-time interaction and communication between patients and their families, so as to improve the mental health and hospitalization experience of patients, as well as improve the satisfaction of patients and families.
Methods and Materials: This single-blind, randomized, controlled trial will be conducted from January to December 2023 in the ICU of Peking Union Medical College Hospital (PUMCH). We aim to randomize 566 adult ICU patients with an expected mechanical ventilation time over 24 hours into the VRCS intervention group and the control group (283 in each group). The patients in the VRCS group can see their families in a virtual natural forest environment through VR headsets and communicate with them through an eye-tracking interaction method. Simultaneously, their family members can see and communicate with the patients through smartphones, computers, or TVs at home. The primary objective is to study the effect of VRCS on the mental health and hospitalization experience of MV patients during the ICU stay. The secondary outcome is to assess the effect of VRCS on the incidence of delirium and the quality of patient-family communication during hospitalization.
- Conditions
- Mental Health Issue
- Being tested
- VR collaborative visualization system
- Keywords
- ICU, mechanically ventilated patients, virtual reality, mental health, social connection
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR collaborative visualization systemDevice
Patients wear virtual reality head-mounted displays while family members using smart phones to interact in a same virtual space.
| Study group | Role | What they receive |
|---|---|---|
| VR collaborative visualization group | Experimental | In this intervention system, the stimulation materials, communication interface, collaboration tasks, and immersive 360-degree scenario will be played inside a commercially available head-mounted display on the patient side, as well as these materials will be played in the smartphone on the family members' side. Receives: Device: VR collaborative visualization system |
| 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.
Hospital Anxiety and Depression Scale
The HADS is designed by Zigmond and Snaith in 1983 to assess anxiety and depression symptoms in medical patients, including 14 items and every item scoring from 1 to 4. It includes two scales, one for anxiety (HADS-A) and another for depression (HADS-D). Each scale has 7 items and has a total score range from 7 to 28. The diagnostic criteria are that if the diagnosed person scores more than 11 points on any scale, it can be regarded as a confirmed case.
Measured: 1 year
Secondary outcomes (13)
Blood pressure
The blood pressure(mmHg) will be collected from a bedside monitor every 6 hours until 48 hours after the intervention. Both Systolic and Diastolic Blood Pressure will be measured.
Measured: 1 year
Heart Rate
The heart rate(bpm) will be collected from a bedside monitor every 6 hours until 48 hours after the intervention.
Measured: 1 year
Respiratory rate
The respiratory rate (breaths/min) will be collected from a bedside monitor every 6 hours until 48 hours after the intervention.
Measured: 1 year
Oxygen saturation level
The oxygen saturation level (SpO2, %) will be collected from a bedside monitor every 6 hours until 48 hours after the intervention.
Measured: 1 year
Activation of cranial nerve signals
The activation of cranial nerve signals will be collected from a bedside monitor every 6 hours until 48 hours after the intervention.
Measured: 1 year
Number of Acute Cardiac Events
The number of acute cardiac events is assessed by analgesic drug dosage, which is recorded by the physicians and nurses.
Measured: 1 year
Duration of Mechanical Ventilation
The duration of mechanical ventilation is daily recorded by the physicians and nurses.
Measured: 1 year
ICU Days
The ICU stays are daily recorded by the physicians and nurses in ICU.
Measured: 1 year
Patient Health Questionnaire-9 (PHQ-9)
It includes 9 items and every item is scored from 0 points to 3 points. Thus, the total score is range from 0 to 27 points. The higher the score, the more severe symptoms of the depression. Since the questionnaire relies on patient self-report, all responses should be verified by the clinician, and a definitive diagnosis is made on clinical grounds taking into account how well the patient understood the questionnaire, as well as other relevant information from the patient.
Measured: 1 year
Positive and Negative Affect Schedule (PANAS)
It includes 20 items and each item is scored from 1 point to 5 points. The higher the score, the stronger the emotion. To score the positive effect, one would add up the scores on lines 1, 3, 5, 9, 10, 12, 14, 16, 17 \& 19. Scores may range anywhere from 10 - 50. Higher scores represent higher levels of positive affect. Mean scores: momentary=29.7 and weekly=33.3. To score the negative emotions, one would add up the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18 \& 20. Scores may range anywhere from 10 - 50. Higher scores represent higher levels of negative affect. Mean scores: momentary = 14.8 and weekly = 17.4.
Measured: 1 year
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
The CAM-ICU is designed to monitor and evaluate the incidence of Delirium, which 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 patients with delirium when the results of item (1), item (2), and item (3) / item (4) are positive. The CAM-ICU will be used after the while intervene.
Measured: 1 year
Family In-Patient Communication Survey (FICS)
The FICS is designed by AM Torke et al. to measure the communication experiences of family members of hospitalized patients. It is comprised of 30 items (1-5 points) in which the individual rates how much they agree or disagree with each statement, while some items (indicated with an asterisk) are reverse scored. The first 18 items assess communication - information, while the final 12 items assess emotional support.
Measured: 1 year
Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)
The FS-ICU is designed by Heyland et al to evaluate the family satisfaction level. It can evaluate the family's satisfaction with care (FS-Care) and satisfaction with decision-making (FS-DM). The results include the calculated score on the total instrument (FS-Total) and the calculated scores for the 2 subscales (FS-Care \& FS-DM).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start7 Mar 2023
- Primary completion17 Mar 2024 (estimated)
- Study completion17 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 566 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
- NCT05773131
- Sponsor's protocol ID
- JS-3575-1
- Status last verified
- Jun 2022
- First submitted
- 6 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Cross-Platform VR Collaboration System for Mechanically Ventilated ICU Patients to Improve Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT05773131
- Acronym / sponsor ID
- JS-3575-1
- Conditions
- Mental Health Issue
- Keywords
- ICU, mechanically ventilated patients, virtual reality, mental health, social connection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 17 Mar 2024 (estimated)
- Study completion
- 17 Mar 2024 (estimated)
- First posted
- 17 Mar 2023 (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.
Collaboration between family members and mechanically ventilated (MV) patients in the intensive care unit (ICU) is essential for improving patients' hospitalization experiences and outcomes. However, numerous hospitals have reduced the visiting time and frequency in ICUs due to the global spread of SARS-CoV-2 in recent years, aggravating mental problems and reducing the satisfaction of ICU patients and their families. Therefore, we propose an effective intervention strategy to enhance patient-family bonding and improve patient mental health and ICU experience by constructing a remote cross-platform virtual reality collaboration system (VRCS) for connecting family members at home with patients in the ICU. We aim to assess the effects of VRCS on the mental health of ICU patients.
Detailed description
Introduction: The ICU is a specialized medical unit equipped with state-of-the-art monitoring equipment and life support machines to provide care for critically ill patients. Patients in the ICU receive extensive and dynamic monitoring to ensure the timely and effective treatment to reduce mortality rates. However, despite the benefits of ICU care, patients may experience severe mental distress and poor hospital experiences due to a variety of factors. In fact, studies have shown that a majority of ICU patients (over 60%) experience long-lasting psychological problems. Current studies have shown that involving families in the care process can help patients feel more secure and lead to greater satisfaction among patients and their families. But due to nosocomial infection, most ICUs still adopt a restrictive visiting strategy. Therefore, we propose a virtual visiting method based on a remote cross-platform VR collaboration system (VRCS) to help patients get rid of the stressful ICU environments, and provide real-time interaction and communication between patients and their families, so as to improve the mental health and hospitalization experience of patients, as well as improve the satisfaction of patients and families.
Methods and Materials: This single-blind, randomized, controlled trial will be conducted from January to December 2023 in the ICU of Peking Union Medical College Hospital (PUMCH). We aim to randomize 566 adult ICU patients with an expected mechanical ventilation time over 24 hours into the VRCS intervention group and the control group (283 in each group). The patients in the VRCS group can see their families in a virtual natural forest environment through VR headsets and communicate with them through an eye-tracking interaction method. Simultaneously, their family members can see and communicate with the patients through smartphones, computers, or TVs at home. The primary objective is to study the effect of VRCS on the mental health and hospitalization experience of MV patients during the ICU stay. The secondary outcome is to assess the effect of VRCS on the incidence of delirium and the quality of patient-family communication during hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR collaborative visualization group | Experimental | Device: VR collaborative visualization systemIn this intervention system, the stimulation materials, communication interface, collaboration tasks, and immersive 360-degree scenario will be played inside a commercially available head-mounted display on the patient side, as well as these materials will be played in the smartphone on the family members' side. |
| Standard ICU Care | No intervention | –Patients will be treated with standard ICU care and not receive VR stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mechanical ventilation time > 24h, and is currently undergoing mechanical ventilation;
- Age ≥ 18 years old, no upper age limit;
- Language: Chinese;
- RAAS score ≥ -2 points;
- Hemodynamic stability.
Key exclusion criteria (3 listed)
- Severe visual impairment (WHO classification: severe visual impairment) or hearing impairment (WHO classification: severe hearing loss);
- Cognitive and consciousness impairment;
- Head trauma or surgery resulting in an inability to wear HMDs.
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 |
|---|---|---|
| VR collaborative visualization systemPatients wear virtual reality head-mounted displays while family members using smart phones to interact in a same virtual space. | Device | VR collaborative visualization group |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: 1 year
The HADS is designed by Zigmond and Snaith in 1983 to assess anxiety and depression symptoms in medical patients, including 14 items and every item scoring from 1 to 4. It includes two scales, one for anxiety (HADS-A) and another for depression (HADS-D). Each scale has 7 items and has a total score range from 7 to 28. The diagnostic criteria are that if the diagnosed person scores more than 11 points on any scale, it can be regarded as a confirmed case.
13 secondary outcomes
Blood pressure
Time frame: 1 year
Heart Rate
Time frame: 1 year
Respiratory rate
Time frame: 1 year
Oxygen saturation level
Time frame: 1 year
Activation of cranial nerve signals
Time frame: 1 year
Number of Acute Cardiac Events
Time frame: 1 year
Duration of Mechanical Ventilation
Time frame: 1 year
ICU Days
Time frame: 1 year
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 1 year
Positive and Negative Affect Schedule (PANAS)
Time frame: 1 year
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Time frame: 1 year
Family In-Patient Communication Survey (FICS)
Time frame: 1 year
Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
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. This study is not recruiting at the moment.
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 VR collaborative visualization system in people with Mental Health Issue, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. 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?
Results are not available in the source record.
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?
Hospital Anxiety and Depression Scale (time frame: 1 year). 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 17 Mar 2023.