Effects and Mechanism of Guided Virtual Reality Autogenic Meditation on ICU Sleep
Primary Purpose
Critical Illness, Sleep Quality
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Virtual reality and eye mask
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness focused on measuring intensive care unit, Sleep Disturbance, Virtual reality
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
Sites / Locations
- Taipei Medical University Hospital.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Virtual reality
Eye masks
Control group
Arm Description
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.
Participants will receive eye masks during their sleep for consecutive two days or until discharge from ICU.
The control group only receive routine care.
Outcomes
Primary Outcome Measures
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.
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.
Changes in subjective sleep quality from 1st day and 2th day after ICU admission
Objective sleep quality in ICU is measured by fitbit
Secondary Outcome Measures
Change of quality of life from the first day of ICU admission, 30 and 180 days after ICU discharge
Quality of life is assessed by EuroQol- 5 Dimension(ED-5D). The total score is 0-100.The higher score means the better quality of life.
Delirium occurrence
Delirium is assessed by Confusion Assessment Method for the ICU (CAM-ICU).
Change of heart rate variability
Heart rate variability is measured by portable ECG recorder and analyzer.
Change from baseline on anxiety
Anxiety is assessed by Visual Analog Scale (VAS) anxiety scoring.The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain(score of 10) .The higher score means the very anxiety.
Electroencephalography
Electroencephalography is measured by Neurosky mindwave mobile 2
Change of stress
Stress is assessed by Visual Analog Scale(VAS) stress scoring.The scale is most commonly anchored by "no stress" (score of 0) and "very stressful(score of 10) .The higher score means the very stressful.
Change of pain
Pain is assessed by Visual Analog Scale(VAS) pain scoring.The scale is most commonly anchored by "no pain" (score of 0) and "very painful(score of 10) .The higher score means the very painful.
Change of cognitive function
Cognitive function is assessed by MoCA. The total scales is 30. The scale is more than 26 means the patients do not have cognitive impairment.
Full Information
NCT ID
NCT05196672
First Posted
December 9, 2021
Last Updated
August 25, 2022
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05196672
Brief Title
Effects and Mechanism of Guided Virtual Reality Autogenic Meditation on ICU Sleep
Official Title
Strategy Establishment of Promoting Sleep Quality and Quantity in Critically Ill Patients: The Effect and Mechanism of Guided-virtual-reality Autogenic Meditation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sleep Quality
Keywords
intensive care unit, Sleep Disturbance, Virtual reality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Eye masks
Arm Type
Experimental
Arm Description
Participants will receive eye masks during their sleep for consecutive two days or until discharge from ICU.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group only receive routine care.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality and eye mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in subjective sleep quality from 1st day and 2th day after ICU admission
Description
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.
Time Frame
The 1st, and 2th night after ICU admission
Title
Change of subjective sleep quality before ICU admission and 30 and 180 days days after ICU discharge
Description
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.
Time Frame
The first day of ICU admission, 30 and 180 days days after ICU discharge
Title
Changes in subjective sleep quality from 1st day and 2th day after ICU admission
Description
Objective sleep quality in ICU is measured by fitbit
Time Frame
The first night and 2th night of ICU stay
Secondary Outcome Measure Information:
Title
Change of quality of life from the first day of ICU admission, 30 and 180 days after ICU discharge
Description
Quality of life is assessed by EuroQol- 5 Dimension(ED-5D). The total score is 0-100.The higher score means the better quality of life.
Time Frame
The 1st day of ICU admission, 30 and 180 days days after ICU discharge
Title
Delirium occurrence
Description
Delirium is assessed by Confusion Assessment Method for the ICU (CAM-ICU).
Time Frame
The 1st to 3th days of ICU admission
Title
Change of heart rate variability
Description
Heart rate variability is measured by portable ECG recorder and analyzer.
Time Frame
The 1st to 2th days of ICU admission
Title
Change from baseline on anxiety
Description
Anxiety is assessed by Visual Analog Scale (VAS) anxiety scoring.The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain(score of 10) .The higher score means the very anxiety.
Time Frame
The 1day (date of enrollment)and up to 30 and 180 days
Title
Electroencephalography
Description
Electroencephalography is measured by Neurosky mindwave mobile 2
Time Frame
The first day to 3th day of ICU admission
Title
Change of stress
Description
Stress is assessed by Visual Analog Scale(VAS) stress scoring.The scale is most commonly anchored by "no stress" (score of 0) and "very stressful(score of 10) .The higher score means the very stressful.
Time Frame
The first day of ICU admission, 30 and 180 days after ICU discharge
Title
Change of pain
Description
Pain is assessed by Visual Analog Scale(VAS) pain scoring.The scale is most commonly anchored by "no pain" (score of 0) and "very painful(score of 10) .The higher score means the very painful.
Time Frame
The first day of ICU admission, 30 and 180 days days after ICU discharge
Title
Change of cognitive function
Description
Cognitive function is assessed by MoCA. The total scales is 30. The scale is more than 26 means the patients do not have cognitive impairment.
Time Frame
The 30 and 180 days after ICU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Yean Chiu, PhD
Phone
+886-2-27361661
Ext
6329
Email
hychiu0315@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Yean Chiu, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University Hospital.
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisao Yean Chiu, PhD
Phone
886227361661 Ext. 6329
Email
hychiu0315@tmu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects and Mechanism of Guided Virtual Reality Autogenic Meditation on ICU Sleep
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