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Trial registered on ANZCTR


Registration number
ACTRN12620000256976
Ethics application status
Approved
Date submitted
11/02/2020
Date registered
27/02/2020
Date last updated
16/03/2020
Date data sharing statement initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability and impact of Smileyscope in the Kimberley region for Aboriginal children, their families, and health professionals.
Scientific title
Evaluating the acceptability and impact of Smileyscope in the Kimberley region for Aboriginal children, their families, and health professionals.
Secondary ID [1] 300499 0
Nil known
Universal Trial Number (UTN)
U1111-1247-9964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management in children required to undergo needle based procedures 316187 0
Needle related anxiety in children required to undergo needle based procedures 316188 0
Condition category
Condition code
Anaesthesiology 314478 314478 0 0
Pain management
Public Health 314479 314479 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The evaluation of Smileyscope as a pain management strategy for Aboriginal children receiving high volume and regular intramuscular injections will occur through two phases:
Phase 1: consented patients will be surveyed about needle pain and anxiety in a usual care setting (monthly for a period of three months)
Phase 2: consented patients will be offered the opportunity to use Smileyscope; a virtual reality headset, designed specifically for children's needle anxiety and pain management.
Virtual reality digital content is played through a smartphone via software application. The smartphone is placed into the a Google Daydream headset which provides a stereoscopic display to create a 3D experience. The virtual reality experience will be provided as an adjunct to standard care (e.g. topical local anaesthetic) during the needle procedure. The content is an animated and immersive age-appropriate visualisation. The intervention will be delivered by the proceduralists (doctors, nurses, Aboriginal Health Workers). The intervention (Smileyscope) will take place for 10 minutes, per monthly visit, for 3 months.
Consented patients will continue to be surveyed about needle pain and anxiety (monthly for a period of 3 months). During Phase 2 families of consented patients and healthcare professionals involved in the administration of the needle will be offered qualitative interviews to discuss process, impacts and acceptability of Smileyscope as a needle pain/anxiety management strategy.
NB: Participants in Phase 1 and Phase 2 will be the same cohort.
Intervention code [1] 316810 0
Treatment: Devices
Intervention code [2] 316811 0
Behaviour
Comparator / control treatment
The data collected on consented patients in phase 1 (usual care phase) will act as comparator for data collected on the same consented patients during phase two (Smileyscope intervention phase).
Control group
Active

Outcomes
Primary outcome [1] 322808 0
Anxiety related to undergoing needle based procedures as assessed by study-specific questionnaire
Timepoint [1] 322808 0
Month one (phase 1)- immediately pre and immediately post procedure
Month two (phase 1)- immediately pre and immediately post procedure
Phase Month three (phase 1)- immediately and immediately post procedure
Month four(phase 2)- immediately pre and immediately post procedure
Month five (phase 2)- immediately pre and immediately post procedure
Month six (phase 2)- immediately pre and immediately post procedure
Primary outcome [2] 322809 0
Pain related to undergoing needle based procedures as assessed by study-specific questionnaire
Timepoint [2] 322809 0
Month one (phase 1)- immediately pre and immediately post procedure
Month two (phase 1)- immediately pre and immediately post procedure
Phase Month three (phase 1)- immediately and immediately post procedure
Month four(phase 2)- immediately pre and immediately post procedure
Month five (phase 2)- immediately pre and immediately post procedure
Month six (phase 2)- immediately pre and immediately post procedure
Secondary outcome [1] 379847 0
Adherence to needle based procedures between standard care (phase 1) and the introduction of Smileyscope (phase 2).
Timepoint [1] 379847 0
6 months post enrolment
Secondary outcome [2] 380611 0
Acceptability for families and healthcare professionals: these groups will be invited to undertake depth interviews on the acceptability of Smileyscope during phase 2 of the study.
Timepoint [2] 380611 0
Five months after enrolment, immediately post needle procedure.
Secondary outcome [3] 380612 0
Impact for families and healthcare professionals: these groups will be invited to undertake depth interviews on the acceptability of Smileyscope during phase 2 of the study
Timepoint [3] 380612 0
Five months after enrolment, immediately post needle procedure.

Eligibility
Key inclusion criteria
Primary sample
1.Children between the age of 4 to 16 years inclusive who have been prescribed large volume and regular intramuscular injections (i.e LA Bicillin injections for children with history of Acute Rheumatic Fever or Rheumatic Heart Disease).

Secondary Samples
2. Parents of eligible children
3. Healthcare professionals of eligible children

Responses below relate to primary sample.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children who are significantly unwell or clinically deteriorating as judged by the treating clinical team
2. Inability to complete consent or study instruments

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/04/2020
Actual
Date of last participant enrolment
Anticipated
25/05/2020
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304917 0
Other
Name [1] 304917 0
Kimberley Aboriginal Medical Services
Country [1] 304917 0
Australia
Funding source category [2] 304996 0
Other
Name [2] 304996 0
Broome Regional Medical Services
Country [2] 304996 0
Australia
Funding source category [3] 304997 0
Other
Name [3] 304997 0
Ord Valley Aboriginal Health Services
Country [3] 304997 0
Australia
Funding source category [4] 304998 0
University
Name [4] 304998 0
Rural Clinical School Western Australia, University of Western Australia
Country [4] 304998 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 305265 0
None
Name [1] 305265 0
n/a
Address [1] 305265 0
n/a
Country [1] 305265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305324 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 305324 0
Ethics committee country [1] 305324 0
Australia
Date submitted for ethics approval [1] 305324 0
28/01/2020
Approval date [1] 305324 0
28/02/2020
Ethics approval number [1] 305324 0
Approval number 969.

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

Contacts
Principal investigator
Name 100002 0
Ms Emma Carlin
Address 100002 0
Rural Clinical School Western Australia
University of Western Australia
12 Napier Trc Broome, WA 6725.
Country 100002 0
Australia
Phone 100002 0
+61419390207
Fax 100002 0
Email 100002 0
emma.carlin@rcswa.edu.au
Contact person for public queries
Name 100003 0
Emma Carlin
Address 100003 0
Rural Clinical School Western Australia
University of Western Australia
12 Napier Trc Broome, WA 6725.
Country 100003 0
Australia
Phone 100003 0
+61419390207
Fax 100003 0
Email 100003 0
emma.carlin@rcswa.edu.au
Contact person for scientific queries
Name 100004 0
Emma Carlin
Address 100004 0
Rural Clinical School Western Australia
University of Western Australia
12 Napier Trc Broome, WA 6725.
Country 100004 0
Australia
Phone 100004 0
+61419390207
Fax 100004 0
Email 100004 0
emma.carlin@rcswa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The minimal data set will be made available upon request, this is due to the small number of eligible participants in a small population. Respecting anonymity is of primary ethical importance.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6834Study protocol  emma.carlin@rcswa.edu.au
6835Informed consent form  emma.carlin@rcswa.edu.au
6836Ethical approval  emma.carlin@rcswa.edu.au
6837Clinical study report  emma.carlin@rcswa.edu.au
6838Statistical analysis plan  emma.carlin@rcswa.edu.au



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.