Restorative virtual environments for rehabilitation

ISRCTN	ISRCTN63077147
DOI	https://doi.org/10.1186/ISRCTN63077147
Secondary identifying numbers	16714

Submission date: 27/06/2014
Registration date: 27/06/2014
Last edited: 29/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Charlotte Small
Scientific

Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44
Email	c.l.flutter@talk21.com

Study information

Study design	Non-randomised; Interventional and Observational; Design type: Process of Care, Qualitative
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	REstorative Virtual Environments for REhabilitation: Does Virtual Nature Therapy enhance sleep on the Intensive Care Unit?
Study acronym	REVERE 1
Study objectives	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(s)	NRES Committee West Midlands - South Birmingham; 26/03/2014, ref: 14/WM/0058
Health condition(s) or problem(s) studied	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
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 study start date	16/06/2014
Completion date	19/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 30; UK Sample Size: 30; Description: see IRAS R&D
Key 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
Key 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
Date of first enrolment	16/06/2014
Date of final enrolment	19/01/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Edgbaston

Birmingham
B15 2TT
United Kingdom

Sponsor information

Queen Elizabeth Hospital (UK)
University/education

Centre for Clinical Haematology
Edgbaston
Birmingham
B15 2TH
England
United Kingdom

"ROR"	https://ror.org/048emj907

Funders

Funder type

Hospital/treatment centre

Defence Medical Services Surgeon General's Research Group; Grant Codes: 20110914_DMSRSG_REFR

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

29/05/2020: No publications found.
11/05/2017: No publications found in PubMed, verifying study status with principal investigator.