Delirium
Conditions
Keywords
ICU, Virtual Reality, Delirium, family support
Brief 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? 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.
Interventions
DEVICEVRFS
Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the VR intervention, blinding of participants and care providers is not feasible. Outcome assessors (nurses responsible for delirium assessment using CAM-ICU) are blinded to group allocation and are not involved in the delivery of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium Day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Days | From ICU admission through ICU discharge, an average of 7 days. | The ICU stays are daily recorded by the physicians and nurses in ICU. |
| Duration of Mechanical Ventilation | From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days. | The duration of mechanical ventilation is daily recorded by the physicians and nurses. |
| Dosage of sedative and analgesic drugs | Daily from Day 1 through ICU discharge, an average of 7 days. | Daily records by doctors and nurses. |
| Incidence of Delirium | Twice daily from Day 1 through ICU discharge, an average of 7 days. | 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). |
| Family Satisfaction with Care in the Intensive Care Unit (FS-ICU) | At baseline (Day 0) and within 3 days after ICU discharge. | 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). |
Countries
China
Contacts
CONTACTYingying Yang, MD
STUDY_DIRECTORYun Long, MD
Peking Union Medical College
Outcome results
None listed