Critical IllnessNCT05196672
Effects and Mechanism of Guided Virtual Reality Autogenic Meditation on ICU Sleep
A study testing Virtual reality and eye mask in people with Critical Illness and Sleep Quality, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Illness, Sleep Quality
- What is being tested?
- Virtual reality and eye mask
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2022to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategy Establishment of Promoting Sleep Quality and Quantity in Critically Ill Patients: The Effect and Mechanism of Guided-virtual-reality Autogenic Meditation
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.
Read the 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
- Being tested
- Virtual reality and eye mask
- Keywords
- intensive care unit, Sleep Disturbance, Virtual reality
- Medical subject headings
- Critical Illness, Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality and eye maskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual reality and eye mask |
| Control group | No intervention | The control group only receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
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.
Measured: The 1st day of ICU admission, 30 and 180 days days after ICU discharge
Delirium occurrence
Delirium is assessed by Confusion Assessment Method for the ICU (CAM-ICU).
Measured: The 1st to 3th days of ICU admission
Change of heart rate variability
Heart rate variability is measured by portable ECG recorder and analyzer.
Measured: The 1st to 2th days of ICU admission
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.
Measured: The 1day (date of enrollment)and up to 30 and 180 days
Electroencephalography
Electroencephalography is measured by Neurosky mindwave mobile 2
Measured: The first day to 3th day of ICU admission
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.
Measured: The first day of ICU admission, 30 and 180 days after ICU discharge
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.
Measured: The first day of ICU admission, 30 and 180 days days after ICU discharge
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.
Measured: The 30 and 180 days after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start17 Jan 2022
- Primary completion2 Aug 2022
- Study completion24 Mar 2023
Why it stopped: Because of the pandemic, is difficult to recruit the participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
- Investigators
- Hsiao-Yean Chiu, PhD, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196672
- Sponsor's protocol ID
- N202104057
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy Establishment of Promoting Sleep Quality and Quantity in Critically Ill Patients: The Effect and Mechanism of Guided-virtual-reality Autogenic Meditation
- ClinicalTrials.gov ID
- NCT05196672
- Acronym / sponsor ID
- N202104057
- Conditions
- Critical Illness, Sleep Quality
- Keywords
- intensive care unit, Sleep Disturbance, Virtual reality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the pandemic, is difficult to recruit the participants
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Behavioral: Virtual reality and eye maskParticipants 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. |
| Eye masks | Experimental | Behavioral: Virtual reality and eye maskParticipants will receive eye masks during their sleep for consecutive two days or until discharge from ICU. |
| Control group | No intervention | –The control group only receive routine care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality and eye maskAdults 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. | Behavioural | Eye masks, Virtual reality |
Primary outcome
Changes in subjective sleep quality from 1st day and 2th day after ICU admission
Time frame: The 1st, and 2th night 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
Time frame: The first day of ICU admission, 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
Time frame: The first night and 2th night of ICU stay
Objective sleep quality in ICU is measured by fitbit
8 secondary outcomes
Change of quality of life from the first day of ICU admission, 30 and 180 days after ICU discharge
Time frame: The 1st day of ICU admission, 30 and 180 days days after ICU discharge
Delirium occurrence
Time frame: The 1st to 3th days of ICU admission
Change of heart rate variability
Time frame: The 1st to 2th days of ICU admission
Change from baseline on anxiety
Time frame: The 1day (date of enrollment)and up to 30 and 180 days
Electroencephalography
Time frame: The first day to 3th day of ICU admission
Change of stress
Time frame: The first day of ICU admission, 30 and 180 days after ICU discharge
Change of pain
Time frame: The first day of ICU admission, 30 and 180 days days after ICU discharge
Change of cognitive function
Time frame: The 30 and 180 days after ICU discharge
Results and safety
The study was stopped early (reason given: Because of the pandemic, is difficult to recruit the participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Yean Chiu, PhD study director
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and eye mask in people with Critical Illness and Sleep Quality, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of the pandemic, is difficult to recruit the participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in subjective sleep quality from 1st day and 2th day after ICU admission (time frame: The 1st, and 2th night after ICU admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.