ANZCTR - Registration

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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]

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

Condition category

Condition code

Injuries and Accidents

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]

Treatment: Other

Comparator / control treatment

No Child Life Therapy and its consequences in paediatric burns management.

Control group

Active

Outcomes

Primary outcome [1]

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]

At initial dressing change at our service.

Secondary outcome [1]

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]

Assessed immediately after the initial dressing change at our service.

Secondary outcome [2]

Staff rated pain and anxiety scores (0-10, with 10 being the worst pain and anxiety).

Timepoint [2]

Assessed immediately after the initial dressing change at our service.

Secondary outcome [3]

Parent rated pain and anxiety scores (0-10) before the procedure.

Timepoint [3]

Assessed immediately before the initial dressing change at our service.

Secondary outcome [4]

Parent rated pain and anxiety score (0-10) during the procedure.

Timepoint [4]

Assessed immediately after the initial dressing change at our service.

Secondary outcome [5]

Child-rated pain and anxiety scores (using Wong Baker/Visual Analogue Scale and Children's Fear Scale) rated during procedure.

Timepoint [5]

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?

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]

The Children's Hospital at Westmead - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Children's Hospital at Westmead (Self funded)

Address [1]

Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Children's Hospital Network Human Research Ethics Committee

Ethics committee address [1]

The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/11/2013

Approval date [1]

20/01/2014

Ethics approval number [1]

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

Dr Ela Hyland

Address

The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 1029

Fax

ela.hyland@health.nsw.gov.au

Contact person for public queries

Name

Ela Hyland

Address

The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145

Country

Australia

Phone

+62 2 9845 1029

Fax

ela.hyland@health.nsw.gov.au

Contact person for scientific queries

Name

Ela Hyland

Address

The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 1029

Fax

ela.hyland@health.nsw.gov.au

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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