Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/02/2005
Date assigned
23/02/2005
Last edited
13/10/2009
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

Prof Karen Grimmer

ORCID ID

Contact details

Centre for Allied Health Evidence
University of South Australia
Adelaide
5000
Australia
+61 (0)8 83022769
karen.grimmer@unisa.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

VR for pain relief

Study hypothesis

The efficacy of playing a virtual reality (VR) game in modulating pain for children with acute burn injuries

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Paediatric burns

Intervention

The test administrations of routine pharmacological analgesia or routine pharmacological analgesia coupled with virtual reality were randomly assigned to each half of the burns dressing change (removal of existing burns dressings or application of fresh dressings) following a coin toss determining the sequence. The child and parents were given a standard explanation about the VR administration and the VR game. If required, subjects were allowed a short preview to assist them to understand how to play the game.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The subjects were asked to score their average pain experience at the end of each phase of the dressing change procedure (VR and pharmacological analgesics, and pharmacological analgesics only). Pain was scored using a modified self-report Faces pain scale. The scale depicts increasing levels of pain and is offered in combination with a visual analogue scale of 0-10, associated with each picture representing a level of pain. Parents/carers and nurses were also interviewed by the data collector at these times, using open ended questions to obtain views regarding the child's anxiety and perception of pain, and utility of VR in a clinical setting.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

All children admitted to one specific ward (Newlands Ward), Women's and Children's Hospital, aged between 5 and 18 years, having burns to more than three percent of their body surface area, and requiring dressing changes, were eligible for inclusion in the study.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

9

Participant exclusion criteria

Children with burns to their hands, face or head, past history of epilepsy and reduced intellectual capacity were not included, as they would have been unable to appropriately use the VR equipment.

Recruitment start date

01/01/2004

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Allied Health Evidence
Adelaide
5000
Australia

Sponsor information

Organisation

Women's and Children's Hospital (Australia)

Sponsor details

c/o Tony Sparnon
Adelaide
5000
Australia
drews@wch.sa.gov.au

Sponsor type

Hospital/treatment centre

Website

http://www.wch.sa.gov.au/

Funders

Funder type

University/education

Funder name

University of South Australia (Australia)

Alternative name(s)

UniSA

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Australia

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15745448

Publication citations

  1. Results

    Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH, The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]., BMC Pediatr, 2005, 5, 1, 1, doi: 10.1186/1471-2431-5-1.

Additional files

Editorial Notes