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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Impact Pain, Anxiety and Stress Levels Have on Acute Burn Wound Healing in Children
Scientific title
A prospective randomised control trial in children 4-12 years with an acute burn injury will determine the effect of the Ditto (Trademark(TM)) virtual reality-based intervention on time to healing (re-epithelialisation) when compared to standard practice (e.g. parental soothing, toys, books, TV).
Secondary ID [1] 262872 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing of acute burn injuries in children 270587 0
Pain, anxiety and stress during wound care procedures 270589 0
Condition category
Condition code
Injuries and Accidents 270759 270759 0 0

Study type
Description of intervention(s) / exposure
At every dressing change, before the wound care procedure, the child engages in the procedural preparation story called "Bobby gets a burn" on the Ditto(TM) device. This takes place in the waiting area during the 20 minute waiting period for medication to take effect. Then in the treatment room, during wound care procedures the child is distracted through engagement in touch and find stories or games on the Ditto(TM). The child begins to use the distraction phase of the Ditto just before the nurse commences the wound care procedures and continues to engage in games/stories until the completion of the wound care procedures.
This is repeated at every dressing change until healing.
Intervention code [1] 269222 0
Treatment: Devices
Comparator / control treatment
Standard practice - the nurse may inform the child and describe what they intend to do during the wound care procedures. Standard distraction includes the nurse chatting and distract them, parental soothing, toys, books and TV.
Control group

Primary outcome [1] 279454 0
Wound healing (re-epithelialisation) measured through the Visitrak(TM) (performed every dressing change to track the size of the wound, marking wet and dry areas) as it heals over time; blinded review of photos; and consultant clinical judgement will also be used to determine days until re-epithelialisation.

A scan will be performed with a laser Doppler imager on the first change of dressings to measure wound depth for comparison of wound healing and to assist in determining whether skin grafting is required.
Timepoint [1] 279454 0
Measured every dressing change until re-epithelialisation. (Dressings are usually changed every 3 days).
Secondary outcome [1] 287681 0
Stress will be measured through collection of saliva samples using Salivettes to be analysed for cortisol and alpha-amylase.
Timepoint [1] 287681 0
Collected every dressing change at:
1) Entering waiting area
2) 0 minutes post dressing removal
3) 10 minutes post dressing removal
Then 3 months after re-epithelisation, a baseline saliva sample will be obtained.
Secondary outcome [2] 287687 0
Pain levels measured though self-report from the child using the faces pain scale revised and observational/behavioural FLACC scale (faces, legs, activity, cry, consolability) from nursing staff.
Timepoint [2] 287687 0
Pain ratings collected every dressing change at intervals:
1) upon entering waiting area of outpatient burns clinic (baseline)
2) upon entering treatment room
3) after dressing removal and wound debridement (retrospective score)
4) after new dressing application (retrospective score)
Secondary outcome [3] 287688 0
Anxiety will be measured using a VAS-Anxiety (visual analog scale) with children 8 years and above.

A Children's Trauma Screening Questionnaire (CTSQ) will be performed to determine long-term effects of anxiety and stress.
Timepoint [3] 287688 0
VAS-A will be measured alongside pain levels:
1) upon entering waiting area of outpatient burns clinic (baseline)
2) upon entering treatment room
3) after dressing removal and wound debridement (retrospective score)
4) after new dressing application (retrospective score)

The CTSQ will be completed on the first dressing change and then 3 months after re-epithelisation.

Key inclusion criteria
- Children 4-12 years
- Outpatients
- Acute burn injury
- Any burn depth
- Total body surface area (TBSA) of the burn<15%
- First dressing change (recruited)
Minimum age
4 Years
Maximum age
12 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Non-English speaking
- Cognitive impairment
- Visual impairment
- Auditory impairment
- Diagnosis of ASD or illness in addition to burn
- Sedative medication (Midazolam, Entonox)
- Children managed under Child Protection, or known to the Child Advocacy Service (CAS) or children notified for Suspician of Child Abuse or Neglect (SCAN).
- Data will be collected until the time point of a burn requiring grafting

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children presenting at the Stuart Pegg Paediatric Burns Centre (SPPBC) at the Royal Children’s Hospital (RCH) Brisbane will be screened on admission for eligibility to this Prospective Randomised Control Trial.

All children will continue to receive standard pain medication protocols and standard medical treatment throughout the study. Children presenting for their first dressing change who meet inclusion criteria and give informed consent will be randomly allocated to the Ditto treatment of control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A portable random number generator will be used with an odd number representing Ditto treatment group and an even number representing the control group.

A Qld Health staff member will be asked to check the random number generator and inform the primary researcher which group the child has been randomised to.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269692 0
Commercial sector/Industry
Name [1] 269692 0
Diversionary Therapy Technologies
Address [1] 269692 0
PO Box 2608, Toowong,
Qld 4066
Country [1] 269692 0
Funding source category [2] 269732 0
Name [2] 269732 0
Royal Children's Hospital
Address [2] 269732 0
Stuart Pegg Paediatric Burns Centre
Royal Children's Hospital
Herston Rd,
Qld, 4029
Country [2] 269732 0
Primary sponsor type
Commercial sector/Industry
Diversionary Therapy Technologies
PO Box 2608,
Qld 4066
Secondary sponsor category [1] 268776 0
Name [1] 268776 0
Royal Children's Hosptal
Address [1] 268776 0
Stuart Pegg Paediatric Burns Centre
Royal Children's Hospital
Herston Rd
Qld, 4029
Country [1] 268776 0
Secondary sponsor category [2] 268777 0
Name [2] 268777 0
The University of Queensland
Address [2] 268777 0
Queensland Children's Medical Research Institute
Level 4, Foundation Building,
Royal Children's Hospital,
Herston Rd,
Qld, 4029
Country [2] 268777 0

Ethics approval
Ethics application status
Ethics committee name [1] 271654 0
Qld Children's Health Services (RCH), Human Research Ethics Committee
Ethics committee address [1] 271654 0
Chief Operations Manager,
Level 5, Woolworths Medical Building,
Herston Road,
Qld, 4029
Ethics committee country [1] 271654 0
Date submitted for ethics approval [1] 271654 0
Approval date [1] 271654 0
Ethics approval number [1] 271654 0
Ethics committee name [2] 271655 0
The University of Queensland, Institutional Approval Form for Experiments on Humans Including Behavioural Research
Ethics committee address [2] 271655 0
The University of Queensland,
Cumbrae-Stewart Building,
Research Road,
Qld, 4072
Ethics committee country [2] 271655 0
Date submitted for ethics approval [2] 271655 0
Approval date [2] 271655 0
Ethics approval number [2] 271655 0

Brief summary
To determine whether the use of the Ditto(TM) device (a virtual reality based portable console, involving procedural preparation and distraction), used during acute burn wound care procedures with children 4-12 years, will result in reduced pain levels, stress levels and anxiety. In addition, determine whether its use will improve the wound healing of children with acute burns compared to standard practice.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33042 0
Address 33042 0
Country 33042 0
Phone 33042 0
Fax 33042 0
Email 33042 0
Contact person for public queries
Name 16289 0
Nadia Brown
Address 16289 0
Level 4, Foundation Building
Royal Children's Hospital
Herston Rd,
Qld, 4029
Country 16289 0
Phone 16289 0
+61 7 3636 4249
Fax 16289 0
Email 16289 0
Contact person for scientific queries
Name 7217 0
Nadia Brown
Address 7217 0
Level 4, Foundation Building
Royal Children's Hospital
Herston Rd,
Qld, 4029
Country 7217 0
Phone 7217 0
+61 7 3636 4249
Fax 7217 0
Email 7217 0

No information has been provided regarding IPD availability
Summary results
No Results