ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

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]

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

Needle related anxiety in children required to undergo needle based procedures

Condition category

Condition code

Anaesthesiology

Pain management

Public Health

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]

Treatment: Devices

Intervention code [2]

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]

Anxiety related to undergoing needle based procedures as assessed by study-specific questionnaire

Timepoint [1]

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]

Pain related to undergoing needle based procedures as assessed by study-specific questionnaire

Timepoint [2]

Secondary outcome [1]

Adherence to needle based procedures between standard care (phase 1) and the introduction of Smileyscope (phase 2).

Timepoint [1]

6 months post enrolment

Secondary outcome [2]

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]

Five months after enrolment, immediately post needle procedure.

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Kimberley Aboriginal Medical Services

Address [1]

12 Napier St, Broome, WA, 6725

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Broome Regional Medical Services

Address [2]

2 Dora St, Broome WA 6725

Country [2]

Australia

Funding source category [3]

Other

Name [3]

Ord Valley Aboriginal Health Services

Address [3]

1125 Ironwood Dr, Kununurra WA 6743

Country [3]

Australia

Funding source category [4]

University

Name [4]

Rural Clinical School Western Australia, University of Western Australia

Address [4]

12 Napier St, Broome, WA 6725

Country [4]

Australia

Primary sponsor type

University

Name

The University of Western Australia

Address

35 Stirling Highway
CRAWLEY WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

n/a

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Australian Aboriginal Health Ethics Committee

Ethics committee address [1]

450 Beaufort Street
Highgate WA 6003

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/01/2020

Approval date [1]

28/02/2020

Ethics approval number [1]

Approval number 969.

Summary

Brief summary

Evaluating the impact of the Smileyscope will assist participating health services in determining the ongoing adoption of the technology for routine clinical use. The evaluation will also inform other Kimberley health services about the impact and acceptability of Smileyscope for Aboriginal children, their families, and their healthcare professionals  helping to create regional discussions and approaches to paediatric needle pain and anxiety management.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Emma Carlin

Address

Rural Clinical School Western Australia
University of Western Australia
12 Napier Trc Broome, WA 6725.

Country

Australia

Phone

+61419390207

Fax

[email protected]

Contact person for public queries

Name

Emma Carlin

Address

Rural Clinical School Western Australia
University of Western Australia
12 Napier Trc Broome, WA 6725.

Country

Australia

Phone

+61419390207

Fax

[email protected]

Contact person for scientific queries

Name

Emma Carlin

Address

Rural Clinical School Western Australia
University of Western Australia
12 Napier Trc Broome, WA 6725.

Country

Australia

Phone

+61419390207

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
6834	Study protocol	[email protected]
6835	Informed consent form	[email protected]
6836	Ethical approval	[email protected]
6837	Clinical study report	[email protected]
6838	Statistical analysis plan	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically