Effects and Mechanism of Guided Virtual Reality Autogenic Meditation on ICU Sleep

NCT05196672 | Terminated

• 1 other identifier: N202104057
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sleep disturbance is a common complaint reported by critically ill patients, which may in turn prolong the length of intensive care unit (ICU) stay, and increase the risks of delirium and mortality. Environmental factors, such as noise and light exposures contribute to the development of sleep disturbances in ICU. Hypnotics is the most prescribed treatment for managing ICU sleep; however, it only improves light sleep but not deep sleep, and could not deal with sleep disturbances caused by noise or light exposure. Purposes: To examine the effects of guided virtual reality autogenic meditation on sleep quality and quantity in critically ill adults as well as the possible mechanism through which they provide this alleviation. We hypothesize that critically ill adults undergoing guided virtual reality autogenic meditation (VR) will experience greater alleviations in sleep disturbances in comparison with participants in the eye masks and usual care control group (UC). Methods: The three-year, single-blinded randomized controlled trial will employ a three-arm parallel-group design. A total of 120 critical ill adults will be randomly allocated to the VR, Eye masks, or UC groups in a 1:1:1 ratio (40 participants in each group). For the VR group, all participants will experience 30-min, voice-guided autogenic meditation through head-mounted display device at 10 pm for 2 nights (ICU day 2 to day 4). For the Eye masks group, participants will wear eye mask from 10 pm to 7 am for 3 days. For the UC group, they will receive sleep promotion strategies, including reduced light exposure at night, decreased noise, and cluster nursing care during the study period. Primary outcomes are sleep parameters measured by the Chinese version of Richards-Campbell Sleep Questionnaire, Chinese version of Pittsburgh sleep quality index, and fitbit with one-lead electroencephalography sensor. Secondary outcomes consist of delirium, moods, and quality of life assessed using the Confusion Assessment Method for the Intensive Care Unit, visual analogue scale for anxiety, pain, stress, EuroQoL-5D, and cognitive function respectively. Measurement time points are the first day of ICU admission, pre-and post-treatment, and the day of 30 and 180 days after ICU discharge. A generalized estimating equation will be used to test research hypotheses.

Conditions

Critical Illness; Sleep Quality

Keywords

intensive care unit; Sleep Disturbance; Virtual reality

Outcome Measures

Primary Outcomes (3)

• Changes in subjective sleep quality from 1st day and 2th day after ICU admission

  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, and 2th night after ICU admission

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

  Subjective 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 first day of ICU admission, 30 and 180 days days after ICU discharge

• Changes in subjective sleep quality from 1st day and 2th day after ICU admission

  Objective sleep quality in ICU is measured by fitbit

  The first night and 2th night of ICU stay

Secondary Outcomes (8)

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

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

• Delirium occurrence

  The 1st to 3th days of ICU admission

• Change of heart rate variability

  The 1st to 2th days of ICU admission

• Change from baseline on anxiety

  The 1day (date of enrollment)and up to 30 and 180 days

• Electroencephalography

  The first day to 3th day of ICU admission

Study Arms (3)

Virtual reality

EXPERIMENTAL

Participants will receive virtual reality for 30 minutes before bedtime and then will be placed on an eye mask for a whole night's sleep for consecutive two days or until discharge from ICU. A total treatment dosage of 60 minutes is required.

Behavioral: Virtual reality and eye mask

Eye masks

EXPERIMENTAL

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

Behavioral: Virtual reality and eye mask

Control group

NO INTERVENTION

The control group only receive routine care.

Interventions

Virtual reality and eye mask BEHAVIORAL

Adults will receive a virtual reality program 30 min before bedtime and then be placed on an eye mask during their sleep for consecutive 2 nights of ICU stay.

Eye masks; Virtual reality

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.
• Clear consciousness and able to communicate with Chinese or Mandarin.
• Expect to stay in ICU for more than 72 hrs

You may not qualify if:

• The use of invasive mechanical ventilation.
• Having visual or hearing difficulty
• Having a medical history of sleep disorder, cognition impairment, psychiatric disorders, or seizures.
• Having sedation use
• Having APACHE II over 25

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Critical Illness; Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hsiao-Yean Chiu, PhD

  Taipei Medical University

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 19, 2022
• Study Start: January 17, 2022
• Primary Completion: August 2, 2022
• Study Completion: March 24, 2023
• Last Updated: April 22, 2024

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)