Clinical trial NCT05518955: VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU
Official title: Strategies Establishment for Promoting Sleep Quality and Quantity of Patients Requiring Intensive Care: Verifying the Effect of Virtual Reality Integrated Into Multicomponent Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Care
Sleep Quality
Keywords: Intensive care unit
Sleep deprivation
Virtual reality
multicomponent intervention
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: The patients who are admitted to ICUs mostly experience sleep disturbance. Seeking an effective strategy and integrating it into the daily routine is of clinical importance. Therefore, we aim to examine the effects of guided virtual reality integrated into the multicomponent program (SLEEP care) on sleep quality and quantity in critically ill patients. This will be a randomized controlled trial with assessor-blinded and two-arm parallel-group design. A total of 120 critical ill adults will be randomly allocated to the SLEEP care group and eyemask groups in a 1:1 ratio (60 participants in each group).

Detailed description: This study is expected to enroll 120 critically ill patients. We will collect basic data on the first day of admission to the intensive care unit, including demographics and disease characteristics, pain, anxiety, and stress, sleep quality and quantity, measure 5-minute HRV, wear an actigraph watch, and connect to the on-lead EEG sensor, and attach the brain wave to monitor the brain wave and sleep cycle. Then they will be randomly assigned 1:1, dividing into SLEEP care group and eyemask group. Participants who are in the control will receive eyemask intervention and daily care in the ICU. Participants who are assigned to the SLEEP care group will receive the VR and night sleep promotion routine. The researcher will assist participants to wear a virtual reality helmet for a 30-minute program at 10 pm, and then remove the helmet and wear eye masks until 6:30 in the morning. The ICU routine care of promoting sleep is still maintained. The next morning (the second day of the ICU), the researcher will assist participants to remove EEG sensors and evaluate the RCSQ scale to understand the previous night's sleep. The above process will repeat for three days (ICU days 1 to 3) until the intervention and measurement during the intensive care unit are completed on the morning of the fourth day. In order to understand the impact of sleep on cognitive function during the stay in the intensive care units and after discharge, the PSQI, VAS of pain, anxiety, and stress (confounders), and MOCA will be evaluated in the first and sixth months after discharge.

Eligibility criteria: Inclusion Criteria:

* Aged 20 years and above.
* Conscious and able to communicate with Chinese or Mandarin.
* To stay in ICU at least 72 hrs

Exclusion Criteria:

* The medical history of sleep disorder, cognition impairment, psychiatric disorders, seizures, visual difficulty or hearing difficulty
* The APACHE II score over than 25
* The participates who are delirium

Primary outcomes:
measure: Changes in subjective sleep quality from first day to 3rd day of ICU recruitment
timeFrame: The 1st to 3rd day of ICU recruitment
measure: Change of subjective sleep quality from before ICU and admission for 30 and 180 days after ICU discharge
timeFrame: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge
measure: Change of objective sleep from 1st day to 3rd day of ICU recruitment
timeFrame: The 1st day to 3rd day of ICU recruitment
Secondary outcomes:
measure: Change of quality of life from the first day of ICU recruitment, 30 and 180 day after ICU discharge
timeFrame: The 30 and 180 days after ICU discharge
measure: Delirium occurrence
timeFrame: The 1st to 3th days of ICU recruitment
measure: Change of heart rate variability
timeFrame: The 1st and 3rd days of ICU recruitment
measure: Change from baseline on anxiety
timeFrame: the 1st day of ICU recruitment and up to 30 and 180 days
measure: Change of stress
timeFrame: The 1st day of ICU recruitment, 30 and 180 days after ICU discharge
measure: Change of pain
timeFrame: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge
measure: Electroencephalography
timeFrame: The 1st day to 3rd day of ICU recruitment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital.
Study officials:
affiliation: Taipei Medical University Hospital
name: Hsiao-Yean Chiu
role: PRINCIPAL_INVESTIGATOR
References: