NCT05196672

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

Terminated NA Last updated 22 April 2024

What this trial tests

NA trial testing Virtual reality and eye mask in Critical Illness in 15 participants. Terminated before completion.

Timeline

17 January 2022

Primary endpoint
2 August 2022

24 March 2023

Quick facts

Lead sponsor	Taipei Medical University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	15
Start date	17 January 2022
Primary completion	2 August 2022
Estimated completion	24 March 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Virtual reality and eye mask

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Sleep Quality — all drugs for Sleep Quality →

Sponsor

Taipei Medical University

Who can join

20 and older, any sex, with Critical Illness or Sleep Quality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.