Contact information
Type
Scientific
Primary contact
Dr Charlotte Small
ORCID ID
Contact details
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44
c.l.flutter@talk21.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16714
Study information
Scientific title
REstorative Virtual Environments for REhabilitation: Does Virtual Nature Therapy enhance sleep on the Intensive Care Unit?
Acronym
REVERE 1
Study hypothesis
Interactive technology can be used to improve the patients perception of their environment. Engagement in this environment will lead to relaxation and improvement in sleep quality.
Ethics approval
NRES Committee West Midlands - South Birmingham; 26/03/2014, ref: 14/WM/0058
Study design
Non-randomised; Interventional and Observational; Design type: Process of Care, Qualitative
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Critical care; Subtopic: Critical care; Disease: All Critical care
Intervention
Exposure to virtual nature therapy (VNT) will comprise:
1. Viewing the virtual reality scene (Virtual Wembury a virtual reality reconstruction of the South Devon coastal path) on a 32in computer screen.
2. Listening to the sounds using noise cancelling headphones (noise cancelling function can be switched off at the patients request)
Three conditions will be used in sequence
A. Static image. Patient unable to navigate or alter their position within Virtual Wembury but objects within Virtual Wembury will move; including sun setting, sea wave motion and animal movements.
B. Toggle view with 180 degree viewing motion. Patients will be able to toggle between different viewpoints and look around from a static position
C. Interactive version of VNT, whereby patients can navigate Virtual Wembury.
Each condition represents increasing complexity of and potential engagement within VNT. Patients offered condition B or C will be able to revert to condition A by not using their hand controllers if they wish. The HIT team will record this activity and the results used to inform patient usage preferences.
The intervention will comprise up to two hours of access to VNT before they go to sleep. This will usually be following the 22:00 drug round prior to their sleep time, however if patients wish to go to sleep earlier they may receive the VNT any time after 20:00. Patients will not be woken up to receive VNT. Should patients fall asleep before receiving VNT and wake before 04:00, they will be offered VNT if they wish to try to go back to sleep. Timings of sleep and offering of VNT will be documented by the nurse caring for the patient
On study day 1 the patient will receive control conditions (no VNT), usual clinical care (night sedation prescription will be standardised, environmental conditions will be recorded).
On study day 2 the patient will be offered VNT A
On study day 3 the patient will offered VNT B
On study day 4 the patient will be offered VNT C
On study day 5 the patient will receive control conditions, usual clinical care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Richard Campbell Sleep questionnaire; Timepoint(s): Each night of study participation
Secondary outcome measures
Secondary outcomes (where overnight is 20:00 08:00):
1. Hours of sleep recorded by nursing staff.
2. Systolic blood pressures, pulse rate, respiratory rate recorded at hourly intervals overnight.
3. Arterial CO2 concentrations recorded at 2-4 hourly intervals (usual care) overnight, or End tidal CO2 concentrations if arterial line not in situ.
4. Presence of delirium, identified by a positive CAM-ICU or RASS score >2 or <-2
5. Pain scores overnight usual numerical rating scale 0-3.
6. Nausea, sickness and anti-emetic use
7. Qualitative patient feedback of factors affecting sleep and their perceptions of the VNT system.
8. Patient usage of VNT duration and type of activity, downloaded directly from embedded software within the VNT system.
Overall trial start date
16/06/2014
Overall trial end date
19/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient in intensive care unit
2. Conscious and able to communicate
3. Aged over 18 years
4. RASS score 1 to +1
5. Considered unlikely to be discharged from critical care for 5 days
Target Gender: Male & Female; Upper Age Limit 90 years ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30; Description: see IRAS R&D
Participant exclusion criteria
1. Bilateral upper limb paralysis or limb loss preventing ability to use hand controller
2. Severe visual or hearing loss
3. Active delirium or psychosis at screening from RASS and CAMICU
scor
4. Severe cognitive impairment including dementia or hepatic encephalopathy
5. Active infection or colonisation with multidrug
resistant organism
Recruitment start date
16/06/2014
Recruitment end date
19/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Defence Medical Services Surgeon General's Research Group; Grant Codes: 20110914_DMSRSG_REFR
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list