VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
Primary Purpose
Delirium
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Virtual Reality Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring ICU, Virtual Reality, Delirium
Eligibility Criteria
Inclusion Criteria:
- Estimated duration of mechanical ventilation ≥ 72 hours.
- Aged ≥ 18 years old.
- Language: Chinese.
- Richmond Agitation Sedation Scale (RASS) ≥ -2.
Exclusion Criteria:
- Severe visual or auditory impairment.
- Cognitive and consciousness impairment prior to ICU admission.
- Severe motion sickness.
- Head trauma or surgery that makes it impossible to wear VR devices.
Sites / Locations
- PUMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VR Stimulation
Standard ICU Care
Arm Description
Patients wear head-mounted displays and experience high immersive virtual environments for treatment.
Patients will be treated with standard ICU care and not receive VR stimulation.
Outcomes
Primary Outcome Measures
Incidence of Delirium
The incidence of 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.
Secondary Outcome Measures
Blood pressure
The blood pressure(mmHg) will be collected from a bedside monitor after the intervention. Both Systolic and Diastolic Blood Pressure will be measured.
Heart rate
The heart rate(bpm) will be collected from a bedside monitor after the intervention.
Respiratory rate
The respiratory rate (breaths/min) will be collected from a bedside monitor after the intervention.
Oxygen saturation level
The oxygen saturation level (SpO2, %) will be collected from a bedside monitor after the intervention.
Activation of cranial nerve signals
The activation of cranial nerve signals will be collected from a bedside monitor after the intervention.
Critical Care Pain Observation Tool (CPOT)
The CPOT includes 4 items, facial expression, physical activity, muscle tone, and ventilation compliance or vocalization. Each item is rated 0-2 points, and the total scale is 0-8 points. The degree of pain is becoming more severe with the increase in total score.
Behavioral Pain Scale (BPS)
The BPS includes 3 items: facial expression, upper extremity movement, ventilation compliance (intubated patients), or vocalization (non-intubated patients), each item is scored from 1 to 4, with a total score of 3 to 12. The degree of pain is becoming more severe with the increase in total score.
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.
Duration of Mechanical Ventilation
The duration of mechanical ventilation is daily recorded by the physicians and nurses.
ICU Days
The ICU stays are daily recorded by the physicians and nurses in ICU.
Family Satisfaction Level
The family satisfaction level is evaluated by the Family Satisfaction with the ICU Survey (FS-ICU), which 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).
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case.
Impact of Event Scale - Revised (IES-R)
The IES-R is designed as a measure of post-traumatic stress disorder (PTSD) symptoms, which includes three subscales, intrusion, avoidance, and hyperarousal. It has 22 items(0 - 4 points), and the total score ranges from 0 to 88 points. 0-8 stands for subclinical, 9-25 stands for mild, 26-43 stands for moderate, and 44-88 stands for severe.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is used for regular depression screenings and includes 9 questions(0 - 3 points). The higher the score, the more severe symptoms of depression.
Positive and Negative Affect Schedule (PANAS)
PANAS is used to test positive and negative emotions in patients. It consists of 20 items (0-4 points) with 10 items for each emotion (0-40 total). The higher the score, the stronger the feeling.
Full Information
NCT ID
NCT05525702
First Posted
July 31, 2022
Last Updated
August 30, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05525702
Brief Title
VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
Official Title
Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients With Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
April 17, 2024 (Anticipated)
Study Completion Date
April 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Delirium is an extremely common complication in mechanically ventilated ICU patients, which can decrease the patients' cognitive function, prolong hospitalization, and even increase mortality. But there is currently no validated treatment for delirium. Therefore, this study aims to build a multi-modal virtual reality (VR) intervention environment to conduct comprehensive interventions in psychological, physiological, and cognitive aspects for ICU mechanically intubated patients, which will be used to improve the hospitalization experience, reduce the prevalence of delirium, and decrease the duration of ICU stay of patients on mechanical ventilation.
Detailed Description
Firstly, the investigators will explore the synergistic mechanism among the sense of presence in virtual environments (VEs), the factor of emotion induction, and the cognitive activation of the neural system for building a beneficial VE for the patients' mental health. On this basis, the investigators will provide the social connection for mechanical ventilation patients by applying cross-platform collaboration VR technology, thereby reducing the negative impact of social isolation, improving the psychological loneliness caused by the separation of family members and patients in the epidemic, and improving the mental health of patients. In terms of physiology, this study will use VR pain distraction technology to improve analgesia in ICU mechanically ventilated patients based on attention-shifting mechanisms. Finally, the investigators will use the paradigm of psychological relief, physiological analgesia, and neurocognitive activation to construct a comprehensive VR cognitive aided diagnosis and cognitive intervention system, and try to assist in the diagnosis and intervention of delirium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
ICU, Virtual Reality, Delirium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR Stimulation
Arm Type
Experimental
Arm Description
Patients wear head-mounted displays and experience high immersive virtual environments for treatment.
Arm Title
Standard ICU Care
Arm Type
No Intervention
Arm Description
Patients will be treated with standard ICU care and not receive VR stimulation.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Treatment
Intervention Description
Patients wear virtual reality head-mounted displays and experience immersive virtual environments.
Primary Outcome Measure Information:
Title
Incidence of Delirium
Description
The incidence of 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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Blood pressure
Description
The blood pressure(mmHg) will be collected from a bedside monitor after the intervention. Both Systolic and Diastolic Blood Pressure will be measured.
Time Frame
2 years
Title
Heart rate
Description
The heart rate(bpm) will be collected from a bedside monitor after the intervention.
Time Frame
2 years
Title
Respiratory rate
Description
The respiratory rate (breaths/min) will be collected from a bedside monitor after the intervention.
Time Frame
2 years
Title
Oxygen saturation level
Description
The oxygen saturation level (SpO2, %) will be collected from a bedside monitor after the intervention.
Time Frame
2 years
Title
Activation of cranial nerve signals
Description
The activation of cranial nerve signals will be collected from a bedside monitor after the intervention.
Time Frame
2 years
Title
Critical Care Pain Observation Tool (CPOT)
Description
The CPOT includes 4 items, facial expression, physical activity, muscle tone, and ventilation compliance or vocalization. Each item is rated 0-2 points, and the total scale is 0-8 points. The degree of pain is becoming more severe with the increase in total score.
Time Frame
2 years
Title
Behavioral Pain Scale (BPS)
Description
The BPS includes 3 items: facial expression, upper extremity movement, ventilation compliance (intubated patients), or vocalization (non-intubated patients), each item is scored from 1 to 4, with a total score of 3 to 12. The degree of pain is becoming more severe with the increase in total score.
Time Frame
2 years
Title
Number of Acute Cardiac Events
Description
The number of acute cardiac events is assessed by analgesic drug dosage, which is recorded by the physicians and nurses.
Time Frame
2 years
Title
Duration of Mechanical Ventilation
Description
The duration of mechanical ventilation is daily recorded by the physicians and nurses.
Time Frame
2 years
Title
ICU Days
Description
The ICU stays are daily recorded by the physicians and nurses in ICU.
Time Frame
2 years
Title
Family Satisfaction Level
Description
The family satisfaction level is evaluated by the Family Satisfaction with the ICU Survey (FS-ICU), which 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).
Time Frame
2 years
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case.
Time Frame
2 years
Title
Impact of Event Scale - Revised (IES-R)
Description
The IES-R is designed as a measure of post-traumatic stress disorder (PTSD) symptoms, which includes three subscales, intrusion, avoidance, and hyperarousal. It has 22 items(0 - 4 points), and the total score ranges from 0 to 88 points. 0-8 stands for subclinical, 9-25 stands for mild, 26-43 stands for moderate, and 44-88 stands for severe.
Time Frame
2 years
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is used for regular depression screenings and includes 9 questions(0 - 3 points). The higher the score, the more severe symptoms of depression.
Time Frame
2 years
Title
Positive and Negative Affect Schedule (PANAS)
Description
PANAS is used to test positive and negative emotions in patients. It consists of 20 items (0-4 points) with 10 items for each emotion (0-40 total). The higher the score, the stronger the feeling.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Estimated duration of mechanical ventilation ≥ 72 hours.
Aged ≥ 18 years old.
Language: Chinese.
Richmond Agitation Sedation Scale (RASS) ≥ -2.
Exclusion Criteria:
Severe visual or auditory impairment.
Cognitive and consciousness impairment prior to ICU admission.
Severe motion sickness.
Head trauma or surgery that makes it impossible to wear VR devices.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingying Yang, MD
Phone
+8618800173833
Email
yangyingying2703@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Long, MD
Organizational Affiliation
Peking Union Medical College
Official's Role
Study Director
Facility Information:
Facility Name
PUMC
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingying Yang, MD
Phone
+8618800173833
Email
yangyingying2703@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
No
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VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
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