VR Interventions to Reduce the Prevalence of Delirium in ICU Patients

Delirium Clinical Trial

Official title:

Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients With Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525702
• Other study ID #: JS-3575
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: April 17, 2024

Study information

• Verified date: June 2022
• Source: Peking Union Medical College Hospital
• Contact: Yingying Yang, MD
• Phone: +8618800173833
• Email: yangyingying2703[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 17, 2024
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• Virtual Reality Treatment
Patients wear virtual reality head-mounted displays and experience immersive virtual environments.

Locations

Country	Name	City	State
China	PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years
Secondary	Heart rate	The heart rate(bpm) will be collected from a bedside monitor after the intervention.	2 years
Secondary	Respiratory rate	The respiratory rate (breaths/min) will be collected from a bedside monitor after the intervention.	2 years
Secondary	Oxygen saturation level	The oxygen saturation level (SpO2, %) will be collected from a bedside monitor after the intervention.	2 years
Secondary	Activation of cranial nerve signals	The activation of cranial nerve signals will be collected from a bedside monitor after the intervention.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	Duration of Mechanical Ventilation	The duration of mechanical ventilation is daily recorded by the physicians and nurses.	2 years
Secondary	ICU Days	The ICU stays are daily recorded by the physicians and nurses in ICU.	2 years
Secondary	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).	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years