Virtual restorative environment therapy for burns dressing changes
| ISRCTN | ISRCTN23330756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23330756 |
| Secondary identifying numbers | 15785 |
- Submission date
- 25/02/2014
- Registration date
- 25/02/2014
- Last edited
- 21/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
| c.l.flutter@talk21.com |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Investigation of virtual restorative environment therapy to aid pain control during dry burns dressing changes |
| Study objectives | 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. |
| Ethics approval(s) | 13/WM/0205 |
| Health condition(s) or problem(s) studied | 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 change the field of view or navigate through the scene. There will be movement associated with the sea and foliage. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 06/01/2014 |
| Completion date | 06/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 25; UK Sample Size: 25 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 06/01/2014 |
| Date of final enrolment | 06/04/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Centre for Defence Medicine (UK) Grant Codes: 20110914DMSRSGVRPLP
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 2017 results presented at Pain Science in Motion 2017: https://www.researchgate.net/publication/316990817_Virtual_Restorative_Environment_Therapy_as_an_adjunct_to_conventional_analgesia_for_procedure_related_pain_in_burns_patients_a_feasibility_study |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/08/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/11/2018: Poster reference added.
