VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU

NCT ID: NCT05518955

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2025-02-03

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.

Conditions

Critical Care; Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Virtual reality combine with sleep promotion routine

Participants will receive virtual reality for 30 minutes before bedtime then will be placed on an eye mask and combine with the sleep promotion routine. The intervention duration need continues for two days or until discharge from ICU.

Group Type: EXPERIMENTAL

Virtual reality and eye mask

Intervention Type: BEHAVIORAL

Participates will receive a virtual reality program 30 min before their sleep and combine with the sleep routine program for consecutive 2 nights in the ICU.

control group

Participants will receive eye masks during their sleep for consecutive two days or until discharge from ICU.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality and eye mask

Participates will receive a virtual reality program 30 min before their sleep and combine with the sleep routine program for consecutive 2 nights in the ICU.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hsiao-Yean Chiu

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Associated professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hsiao-Yean Chiu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

Taipei Medical University Hospital.

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202202058

Identifier Type: -

Identifier Source: org_study_id