VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU

NCT05518955 | Completed

• 1 other identifier: N202202058
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Care; Sleep Quality

Keywords

Intensive care unit; Sleep deprivation; Virtual reality; multicomponent intervention

Outcome Measures

Primary Outcomes (3)

• Changes in subjective sleep quality from first day to 3rd day of ICU recruitment

  Subjective sleep quality in ICU is assessed by Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality.

  The 1st to 3rd day of ICU recruitment

• Change of subjective sleep quality from before ICU and admission for 30 and 180 days after ICU discharge

  sleep quality is assessed by Pittsburgh Sleep Quality. Index(PSQI). The total score is 0-21. The higher score means the worse sleep quality.

  The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge

• Change of objective sleep from 1st day to 3rd day of ICU recruitment

  Objective sleep quality in ICU is measured by actigraphy

  The 1st day to 3rd day of ICU recruitment

Secondary Outcomes (7)

• Change of quality of life from the first day of ICU recruitment, 30 and 180 day after ICU discharge

  The 30 and 180 days after ICU discharge

• Delirium occurrence

  The 1st to 3th days of ICU recruitment

• Change of heart rate variability

  The 1st and 3rd days of ICU recruitment

• Change from baseline on anxiety

  the 1st day of ICU recruitment and up to 30 and 180 days

• Change of stress

  The 1st day of ICU recruitment, 30 and 180 days after ICU discharge

Study Arms (2)

Virtual reality combine with sleep promotion routine

EXPERIMENTAL

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.

Behavioral: Virtual reality and eye mask

control group

NO INTERVENTION

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

Interventions

Virtual reality and eye mask 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.

Virtual reality combine with sleep promotion routine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hsiao-Yean Chiu: lead

Study Sites (1)

Taipei Medical University Hospital.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Deprivation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsiao-Yean Chiu

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: September 20, 2022
• Primary Completion: March 6, 2024
• Study Completion: February 3, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)