Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05525702
Other study ID # JS-3575
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT05891873 - Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT06194474 - Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Completed NCT03095417 - Improving the Recovery and Outcome Every Day After the ICU N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Not yet recruiting NCT04846023 - Pediatric Delirium Screening in the PICU Via EEG N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Withdrawn NCT02673450 - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting NCT03256500 - Transcranial Direct Current Stimulation for the Treatment of Delirium N/A
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Completed NCT02518646 - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models N/A
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Recruiting NCT02305589 - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium N/A
Completed NCT02628925 - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale N/A