Condition category
Not Applicable
Date applied
27/06/2014
Date assigned
27/06/2014
Last edited
11/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Small

ORCID ID

Contact details

Edgbaston
Birmingham
B15 2TT
United Kingdom
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

To date, no group has investigated the use of interactive, virtual reality based technology to modify the ICU patient environment. We hypothesise that 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; 26/032014; 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 controlled trial

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 patient’s 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 measures

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

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

Sponsor information

Organisation

Queen Elizabeth Hospital (UK)

Sponsor details

Centre for Clinical Haematology
Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes