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

NCT05196672 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-04-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

Virtual reality and eye mask

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.

Sponsors & Collaborators

  • Taipei Medical University

    lead OTHER

Principal Investigators

  • Hsiao-Yean Chiu, PhD · Taipei Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2022-08-02
Completion
2023-03-24

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196672 on ClinicalTrials.gov