Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000781741
Ethics application status
Approved
Date submitted
1/04/2022
Date registered
1/06/2022
Date last updated
27/04/2023
Date data sharing statement initially provided
1/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital buddy for preparation of IV insertion
Scientific title
Innovation project exploring the utility of a digital tangata (person) in supporting preparation for insertion of intravenous (IV) cannula in tamariki (children) age 7 to 12 years
Secondary ID [1] 306822 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 325905 0
Condition category
Condition code
Emergency medicine 323217 323217 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an innovation project to determine the usability of a digital buddy in supporting tamariki and matua prior to insertion of an intravenous cannula when a play specialist is not available.
All children attending out of hours when there is no play specialist available will be offered access to the digital buddy.
The digital buddy provides 1. education on what an intravenous cannula is, 2. breathing exercise for distraction/anxiety management, 3. drawing activity for whakawhanaungatanga, 4. practice in remaining still for intravenous cannula insertion and 5. simple games as a distraction following previous activities.
The digital buddy will be presented by a member of the healthcare team - medical or nursing and will be accessed via a hospital tablet.
The digital buddy will be accessed once, prior to insertion of the intravenous cannula, while waiting on local anaesthetic cream to take effect. The duration is anticipated to be for 30 minutes, but will depend on the time the child wishes to interact for.
Location - Children's Emergency Department of Starship Hospital
Participants and parents will complete a brief questionnaire following use of the digital buddy.
The digital buddy is still in development stage, has not been finalised and will not be implemented until final sign off by the development team AND all ethics, locality and research requirements have been approved.
Intervention code [1] 323287 0
Not applicable
Comparator / control treatment
Insertion of an IV cannula when a play specialist is not available.
Data will be collected prior to commencing implementation of the digital buddy. However as we are still in the iterative process of developing the digital buddy software we have not undertaken the data collection for the historical group as yet. Expected dates for collection are 1 to 31 June 2022.
Control group
Active

Outcomes
Primary outcome [1] 330966 0
Change in Tamaiti Self-Reported Rating Procedural Distress
Timepoint [1] 330966 0
End of procedure
Secondary outcome [1] 408305 0
Matua perception of usefulness of digital buddy - Likert scale
Timepoint [1] 408305 0
End of procedure
Secondary outcome [2] 409802 0
Time to set up digital tablet (minutes) as timed by a staff member using timer.
Timepoint [2] 409802 0
End of procedure
Secondary outcome [3] 409803 0
Time tamaiti needed for interaction with Digital Buddy (minutes). This will be obtained from screen access time log from within the digital buddy.
Timepoint [3] 409803 0
End of procedure
Secondary outcome [4] 409804 0
Tamaiti completed interaction with Digital Buddy prior to IV cannula.
Edit for clarity: this is a simple yes no answer and will be available from the digital buddy as there are a number of steps that the tamaiti can complete, if not completed the programme will have a record of this.
Timepoint [4] 409804 0
End of procedure
Secondary outcome [5] 409805 0
Healthcare Provider perception of usefulness of Digital Buddy by questionnaire - designed specifically for this study.
Timepoint [5] 409805 0
End of procedure

Eligibility
Key inclusion criteria
Inclusion Criteria
1. Tamariki admitted to Starship Child Health requiring an IV cannula insertion when play specialist is not available
AND
2. Age 7 to 12 years (7 years 0 days to 12 years 364 days)
AND
3. Able to interact with digital tablet
AND
4. Has time to complete the korerorero
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Significant developmental delay
• Does not speak English

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be presented as summative data demonstrating the use of the digital buddy as perceived by tamariki, matua and healthcare providers.
The utility of digital buddy will be compared with baseline data obtained prior to the study from routine clinical care using the Child Self-Reported Rating Procedural Distress: Visual Analogue Scale/Numerical Rating Scale (0-10) during standard care out of hours, i.e. no digital buddy or play specialist.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
6/06/2022
Actual
15/09/2022
Date of last participant enrolment
Anticipated
31/12/2022
Actual
29/01/2023
Date of last data collection
Anticipated
31/12/2022
Actual
29/01/2023
Sample size
Target
260
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 24702 0
New Zealand
State/province [1] 24702 0
Auckland

Funding & Sponsors
Funding source category [1] 311154 0
Charities/Societies/Foundations
Name [1] 311154 0
Starship Foundation
Country [1] 311154 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Shepherd
Address
c/o Starship Child Health
Grafton Road
Auckland
1010
Country
New Zealand
Secondary sponsor category [1] 312507 0
None
Name [1] 312507 0
none
Address [1] 312507 0
Country [1] 312507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310682 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 310682 0
Ethics committee country [1] 310682 0
New Zealand
Date submitted for ethics approval [1] 310682 0
16/08/2021
Approval date [1] 310682 0
23/03/2022
Ethics approval number [1] 310682 0
21/NTA/163

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

Contacts
Principal investigator
Name 118502 0
Dr Jo Hegarty
Address 118502 0
Douglas Starship Simulation Programme
Starship Child Health
Grafton Road
Auckland
1010
Country 118502 0
New Zealand
Phone 118502 0
+64930725697
Fax 118502 0
Email 118502 0
jhegarty@adhb.govt.nz
Contact person for public queries
Name 118503 0
Jo Hegarty
Address 118503 0
Douglas Starship Simulation Programme
Starship Child Health
Grafton Road
Auckland
1010
Country 118503 0
New Zealand
Phone 118503 0
+6493074949
Fax 118503 0
Email 118503 0
jhegarty@adhb.govt.nz
Contact person for scientific queries
Name 118504 0
Jo Hegarty
Address 118504 0
Douglas Starship Simulation Programme
Starship Child Health
Grafton Road
Auckland
1010
Country 118504 0
New Zealand
Phone 118504 0
+6493074949
Fax 118504 0
Email 118504 0
jhegarty@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Time to set up digital tablet (<5 – 10 minutes). Time needed for interaction with digital buddy (15 - 20 minutes). Ability to complete interaction with digital buddy prior to IV cannula (Yes/No. If no – why not). Tamaiti Self-Reported Rating Procedural Distress: Visual Analogue Scale/Numerical Rating Scale (0-10). Matua perception of usefulness of digital buddy: Likert scale (0-5). Healthcare Provider perception of usefulness of Digital Buddy Likert scale (0-5).
When will data be available (start and end dates)?
From publication of results and available for 5 years after publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator: jhegarty@adhb.govt.nz


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
No additional documents have been identified.