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

NCT ID: NCT05196672

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2023-03-24

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.

Detailed Description

Sleep disturbance has affected up to 59% of patients who are admitted into intensive care units (ICUs). Such disturbance has been associated with prolonged ICU length of stay, the occurrence of delirium, increased medical costs. The risk factors related to poor sleep in ICU patients include bright light, artificial/augmented sound, postoperative pain, prior illness status, higher intensity of care, and equipment applications.

To date, pharmacological and nonpharmacological therapies have been widely used to relieve poor sleep in ICU. Sedative-hypnotic is the most prescribed treatment for critically ill patients with sleep problems. However, related adverse events reduce their usefulness.

According to the 2018 PADIS guideline of the Society of Critical Care Medicine, sleep disturbance has been listed as one of the critical symptoms that must be recognized in a critically clinical setting. Recently, technology-assisted interventions have been increasingly integrated into critical care. Virtual reality (VR) mediation is a promising technology for free from time and space that provides various contents or games to users. To achieve the goal of precision health, more researchers and health care providers have incorporated high technology into medical and nursing care systems. Thus far, only one randomized controlled trial involving 52 ICU patients investigated the effect of VR meditation (natural scenes and sounds) on poor sleep quality and found that the program significantly decreased wake after sleep onset and increased deep sleep time. Therefore, we aim to develop a new VR-assisted program and to examine its effects on sleep quality and quantity of adults requiring intensive care.

Conditions

Critical Illness; Sleep Quality

Study Design

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

Study Groups

Virtual reality

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.

Group Type: EXPERIMENTAL

Virtual reality and eye mask

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Virtual reality and eye mask

Intervention Type: 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.

Control group

The control group only receive routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiao-Yean Chiu, PhD

Role: STUDY_DIRECTOR

Taipei Medical University

Locations

Taipei Medical University Hospital.

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202104057

Identifier Type: -

Identifier Source: org_study_id