Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/02/2014
Date assigned
25/02/2014
Last edited
06/08/2015
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

15785

Study information

Scientific title

Investigation of virtual restorative environment therapy to aid pain control during dry burns dressing changes

Acronym

Study hypothesis

The burns unit at the Queen Elizabeth Hospital Birmingham admits nearly 300 patients a year, including wounded military patients. The pain of a severe burn injury is characterised by an unremitting background pain, coupled with severe exacerbations associated with essential procedures such as dressing changes, staple removal from grafts and physiotherapy. A recent audit showed that 23% of patients experience moderate or severe pain during dressing changes. This study will evaluate the use of an interactive computer game, based on a virtual restorative environment (VRE), as an adjunct to pain management during burns dressing changes.The system has been developed specifically for this patient group to allow usability for all but the most severely injured patients. The study will be a single blinded (data collector only) within-subject crossover trial where patients who are undergoing dry burn dressing changes will be receive non-interactive VRE distraction, interactive VRE distraction and a control condition using standard analgesia over three consecutive dressing changes. The order of conditions will be randomised. The primary outcome will be highest pain score (numerical rating scale) during the dressing change. Secondary outcomes will be average pain scores during dressing change, pain score one hour after dressing change, anxiety, rescue analgesia, usability, level of immersion and satisfaction. Data will also be collected on staff satisfaction with and usability of the system.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15785

Ethics approval

13/WM/0205

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics

Intervention

Virtual reality (active), Interactive game, based within Virtual Wembury, whereby the patient can control movement of a speedboat viewed on a high definition screen, listening to associated sounds via headphones. The speedboat will be controlled by a single-hand use hand controller. Points can be scored by collection objects and steering between buoys.

Virtual reality (passive), Viewing of a nature based virtual world based on Wembury Bay, South Devon coastal path. The VR system consists of a high definition TV screen and headphones to provide sounds of the VR environment. The image will be viewed as if through a window, the patient will not be able to cahnge the field of view or navigate through the scene. There will be movement associated with the sea and foliage.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Worst pain (numerical rating scale); Timepoint(s): During dressing change

Secondary outcome measures

1. Anxiety; Timepoint(s): During dressing change
2. Average pain; Timepoint(s): During dressing change
3. Nausea; Timepoint(s): During dressing change
4. Nursing satisfaction with VR system; Timepoint(s): During dressing change
5. Satisfaction with pain management; Timepoint(s): During dressing change
6. Satisfaction with VR distraction; Timepoint(s): During dressing change
7. Worst pain; Timepoint(s): One hour after dressing change

Overall trial start date

06/01/2014

Overall trial end date

06/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with burns (any cause) admitted to the Queen Elizabeth Hospital Burns Unit
2. Those above requiring at least three dressing changes.
3. Those above requiring opioid based analgesia (eg oral morphine, codeine phosphate or tramadol)or inhaled nitrous oxide (entonox) for the dressing change (ie, patients who may potentially experience moderate or severe pain)
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: 25; UK Sample Size: 25

Participant exclusion criteria

1. Inability to use the interactive distraction equipment eg blindness, severe bilateral hand injuries.
2. Requirement for general anaesthesia or sedation with ketamine or midazolam.
3. Poor cognitive state eg severe dementia, delirium or severe psychiatric illness.
4. Multi-drug resistant infection (due to potential equipment contamination, although low risk, this criteria is appropriate for the feasibility study.)

Recruitment start date

06/01/2014

Recruitment end date

06/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Centre for Defence Medicine (UK) Grant Codes: 20110914DMSRSGVRPLP

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26242401

Publication citations

Additional files

Editorial Notes