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Trial registered on ANZCTR


Registration number
ACTRN12613001238763
Ethics application status
Approved
Date submitted
8/11/2013
Date registered
12/11/2013
Date last updated
28/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Child Life Therapy in Paediatric Burns Management
Scientific title
Effectiveness of Child Life Therapy in pain/anxiety management in paediatric burns: a randomised control trial
Secondary ID [1] 283545 0
Nil
Universal Trial Number (UTN)
U1111-1150-0568
Trial acronym
CLTPBM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric burns - pain and anxiety associated with dressing changes 290454 0
Condition category
Condition code
Injuries and Accidents 290845 290845 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Child Life Therapy (an Allied Health service) and its use in paediatric burns management in reducing pain and anxiety.

Child Life Therapists are allied health professionals who work with children and their families in our Burns Unit to provide coping strategies for painful and anxiety provoking procedures, such as burns dressings. Using age-appropriate tools and play, they provide children with pre-procedural education, pain management and coping strategies. Examples of methods include games, bubbles, music and iPads. They also provide education, peri-procedural support, and guidance for families as well as the child.

These professionals work with children for each dressing change if required by the child. During our study we will be looking at the first dressing change only and the therapist will be present during the entire dressing change.
Intervention code [1] 288238 0
Treatment: Other
Comparator / control treatment
No Child Life Therapy and its consequences in paediatric burns management.
Control group
Active

Outcomes
Primary outcome [1] 290843 0
Each child’s Children’s Hospital of Eastern Ontario Pain Scores (CHEOPS) and Children’s Fear Scores will be assessed by a single trained independent rater and recorded every 5 minutes during the dressing change and associated procedures. The average scores for the procedure for both pain and anxiety will be calculated and their sum used as the primary outcome measure.
Timepoint [1] 290843 0
At initial dressing change at our service.
Secondary outcome [1] 305424 0
The use of any additional sedation or pain relief during procedures will be assessed immediately after the initial dressing change at our service. If additional sedation or pain relief is used, it will be recorded - how much, what pain relief or sedation used.
Timepoint [1] 305424 0
Assessed immediately after the initial dressing change at our service.
Secondary outcome [2] 305474 0
Staff rated pain and anxiety scores (0-10, with 10 being the worst pain and anxiety).
Timepoint [2] 305474 0
Assessed immediately after the initial dressing change at our service.
Secondary outcome [3] 305475 0
Parent rated pain and anxiety scores (0-10) before the procedure.
Timepoint [3] 305475 0
Assessed immediately before the initial dressing change at our service.
Secondary outcome [4] 305476 0
Parent rated pain and anxiety score (0-10) during the procedure.
Timepoint [4] 305476 0
Assessed immediately after the initial dressing change at our service.
Secondary outcome [5] 305477 0
Child-rated pain and anxiety scores (using Wong Baker/Visual Analogue Scale and Children's Fear Scale) rated during procedure.
Timepoint [5] 305477 0
Assessed immediately after the initial dressing change at our service.

Eligibility
Key inclusion criteria
Aged 0-16 years
New burn injury, presenting for the first time at the our Burns and Plastics Treatment Centre at the Children's Hospital at Westmead
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment and inability to use the outcome tool (parent or child- taking into consideration age)
Non-English speaking

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)
Potential participants and their caregivers will be identified in the waiting room on their arrival to our Burns and Plastics Treatment Centre at the Children's Hospital at Westmead for their first dressing change with us. They will be greeted by a recruiter, given information about the study and asked to consent if they wish to participate. They will then be randomised into either study group.

Allocation concealment will occur via centralised randomisation by computer generation (independently provided by our Biostatistician).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised in a 1:1 ratio to CLT therapy versus standard care using permuted blocks. The randomisation will be stratified by the child’s age (0-5 years versus >5 years) and the extent of the burn (<1% TBSA versus greater than or equal to 1%) in order to maintain balance between treatment groups for these prognostic factors. Randomisation will be computer generated and only accessed at time of enrolment. Given the nature of the intervention, it would not be possible to blind the investigators.
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
A small pilot study of this therapy showed a standard deviation of approximately 7 for the combined total score of nurse-rated pain plus anxiety during treatment. A sample size of 50 patients per group will provide 80% power at 5% significance level to detect a difference of 4 in this combined score which ranges from 0 for no pain or anxiety to 20 for maximum pain and anxiety.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
1/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1672 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 7547 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288233 0
Hospital
Name [1] 288233 0
The Children's Hospital at Westmead (Self funded)
Country [1] 288233 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 286952 0
None
Name [1] 286952 0
Address [1] 286952 0
Country [1] 286952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290138 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 290138 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145
Ethics committee country [1] 290138 0
Australia
Date submitted for ethics approval [1] 290138 0
13/11/2013
Approval date [1] 290138 0
20/01/2014
Ethics approval number [1] 290138 0
HREC/13/SCHN/355

Summary
Brief summary
Burns are unfortunately a very common childhood injury. The Burns and Plastics Treatment Centre (BPTC) at the Children’s Hospital at Westmead is the only children’s Burns Unit servicing the children of New South Wales (NSW) and the Australian Capital Territory (ACT). We undertake approximately 3500 burns dressings in our BPTC per year.

When a child presents to our BPTC they are given pain medicines and then taken into a treatment room to have their burns dressing done. These can be extremely painful and anxiety provoking, despite medication. We are very lucky that our service has access to a Child Life Therapist (formerly known as a Play Therapist). This therapist provides patient and family education prior to the procedure, distraction during the procedure from the dressing change occurring independently by nursing staff, and ongoing support after the procedure.

Many studies have shown that Child Life Therapy or distraction therapy may be useful in reducing pain and anxiety in children. None however have shown its benefits for burnt children.

We aim by undertaking this study, to prove that Child Life Therapy is beneficial by reducing pain and anxiety experienced by children during their dressing changes.
To do this, we aim to recruit 100 new burns patients, attending our BPTC for the first time, to our study. Approximately half of these patients will have a Child Life Therapist during their dressing change, the other half will not.

Patients will be greeted in the waiting room and explained the study. They will then be asked to participate. If they choose to participate, they will then be given their regular pain medications. Whilst the pain medications are taking time to work, the parent/carer will be asked to fill out a survey about what they expect the pain and anxiety will be. The child will then be taken into the treatment room with their parent/carer to have their dressing done. During the dressing a medical person will be in the room, watching the dressing and recording pain and anxiety scores in 5 minute intervals. After the dressing is over, the child if >5 years old, the parent/carer, and the nurse involved in the procedure, will all fill out questionnaires about how painful or anxiety provoking they thought the dressing was. These questionnaires will be age appropriate.

This data will then be collected and analysed by our hospital biostatistician. We hope to find that Child Life Therapy is beneficial and support its further use for reducing pain and anxiety associated with childhood procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44154 0
Dr Ela Hyland
Address 44154 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145
Country 44154 0
Australia
Phone 44154 0
+61 2 9845 1029
Fax 44154 0
Email 44154 0
[email protected]
Contact person for public queries
Name 44155 0
Ela Hyland
Address 44155 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145
Country 44155 0
Australia
Phone 44155 0
+62 2 9845 1029
Fax 44155 0
Email 44155 0
[email protected]
Contact person for scientific queries
Name 44156 0
Ela Hyland
Address 44156 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145
Country 44156 0
Australia
Phone 44156 0
+61 2 9845 1029
Fax 44156 0
Email 44156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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