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
Scientific
Edgbaston
Birmingham
B15 2TT
United Kingdom
Phone | +44 |
---|---|
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
B15 2TT
United Kingdom
Sponsor information
Queen Elizabeth Hospital (UK)
University/education
University/education
Centre for Clinical Haematology
Edgbaston
Birmingham
B15 2TH
England
United Kingdom
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.