Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000913976
Ethics application status
Approved
Date submitted
25/08/2011
Date registered
25/08/2011
Date last updated
25/08/2011
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
Nil
Universal Trial Number (UTN)
U1111-1123-8237
Trial acronym
nil
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
Burns

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271654 0
Qld Children's Health Services (RCH), Human Research Ethics Committee
Ethics committee address [1] 271654 0
Ethics committee country [1] 271654 0
Australia
Date submitted for ethics approval [1] 271654 0
08/11/2010
Approval date [1] 271654 0
16/12/2010
Ethics approval number [1] 271654 0
HREC/10/QRCH/99
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
Ethics committee country [2] 271655 0
Australia
Date submitted for ethics approval [2] 271655 0
30/11/2010
Approval date [2] 271655 0
01/12/2010
Ethics approval number [2] 271655 0
2010001523

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
QCMRI,
Level 4, Foundation Building
Royal Children's Hospital
Herston Rd,
Herston,
Qld, 4029
Country 16289 0
Australia
Phone 16289 0
+61 7 3636 4249
Fax 16289 0
Email 16289 0
[email protected]
Contact person for scientific queries
Name 7217 0
Nadia Brown
Address 7217 0
QCMRI,
Level 4, Foundation Building
Royal Children's Hospital
Herston Rd,
Herston,
Qld, 4029
Country 7217 0
Australia
Phone 7217 0
+61 7 3636 4249
Fax 7217 0
Email 7217 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICost-Effectiveness of a Nonpharmacological Intervention in Pediatric Burn Care2015https://doi.org/10.1016/j.jval.2015.04.011
N.B. These documents automatically identified may not have been verified by the study sponsor.