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Trial registered on ANZCTR


Registration number
ACTRN12615000867594
Ethics application status
Approved
Date submitted
3/08/2015
Date registered
20/08/2015
Date last updated
17/12/2019
Date data sharing statement initially provided
17/12/2019
Date results provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
BrightHearts: Using biofeedback mediated relaxation techniques during vaccination of adolescents.
Scientific title
In adolescents, does using biofeedback mediated relaxation techniques during vaccination, compared to standard vaccination process, reduce fear, pain and anxiety associated with school-based vaccination.
Secondary ID [1] 287197 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccine-related fear 295785 0
Vaccine-related pain 295859 0
Vaccine-related anxiety 295860 0
Condition category
Condition code
Public Health 296055 296055 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is an iPad application (‘app') called BrightHearts. The BrightHearts biofeedback iPad app displays a colourful geometric artwork on the iPad, which responds to changes in the individual user’s heart rate transmitted by a wireless pulse oximeter worn on the ear. An auditory component responds to a reduction in heart rate producing musical sounds. The goal of the interaction is to voluntarily decrease one’s heart rate to change the colour and visuals on the screen – from orange to yellow, to green and eventually blue – indicating that the heart rate has reached its lowest rate since the start of the session and hence telling the user that their body is more relaxed.

The app will be trialled at participating schools during a routine school vaccination day. Students will be randomly allocated to use the app or to standard vaccination process. If allocated to use the BrightHearts app research staff will instruct students on how to use the app and attach the pulse oximeter (pre-vaccination). Students will then use the app both prior to and during the vaccination procedure itself. There are no defined minimum or maximum periods of time that the app must used by individual students. If allocated to the standard vaccination process the student will participate as usual in the school’s vaccination day.

Research staff will supervise students while they are using the app prior to vaccination and completing the post-vaccination questionnaire. All research staff will monitor for adverse events related to using the BrightHearts app on vaccination day. Research staff will record the details of any observed adverse events on the study adverse event log.
Intervention code [1] 292481 0
Behaviour
Intervention code [2] 292537 0
Prevention
Comparator / control treatment
Standard vaccination process provided by the school-based immunisation program.
Control group
Active

Outcomes
Primary outcome [1] 295722 0
Student reported pain scoring during vaccination between BrightHearts and standard vaccination process. The Faces Pain Scale-Revised will be used to record the self-reported level of pain the student experiences during the vaccination process.
Timepoint [1] 295722 0
Immediately following vaccination.
Primary outcome [2] 295785 0
Student reported fear scoring during vaccination between BrightHearts and standard vaccination process. The Children’s Fear Scale will be used to record the self-reported level of fear the student experiences during the vaccination process.
Timepoint [2] 295785 0
Immediately following vaccination
Secondary outcome [1] 316336 0
Student reported anxiety score during vaccination between BrightHearts and standard vaccination process. State-Trait Anxiety Inventory for Children will be used to collect data regarding anxiety.
Timepoint [1] 316336 0
Immediately following vaccination.
Secondary outcome [2] 316337 0
Student reported satisfaction with using the BrightHearts app. This will be assessed by asking students allocated to BrightHearts a set four questions regarding their experience of using the app.
Timepoint [2] 316337 0
Immediately following vaccination.
Secondary outcome [3] 316338 0
Immunisation nurse and school personnel perceptions, beliefs and experience of the feasibility, acceptability and implementation of BrightHearts in the school-based immunisation program. Data will be collected during one-on-one interviews with immunisation nurses and school personnel who have supervised students on vaccination day at schools participating in the study. Research staff will use a semi-structured interview guide and prompts will be used to elaborate and clarify a participant’s responses. (Qualitative data)
Timepoint [3] 316338 0
As soon as possible after the vaccination day during which students participated in the study.

Eligibility
Key inclusion criteria
Schools:
1.The school is co-educational, located in the Perth metropolitan area, has greater than or equal to 100 students enrolled in year 8 and is participating in the school-based immunisation program.
2.The Principal has given informed consent for the school to participate in the study.

Students:
1.The participant is enrolled in Year 8 at a school that is participating in the study.
2.The participant is being vaccinated at school as part of the school-based immunisation program.
3.The participant has parent/guardian consent and has also given their assent to participate in the study.
4.The participant is willing and able to comply with using the BrightHearts app.
5.The participant is capable of reading and completing the student questionnaire.

Immunisation nurses:
1.The participant is a nurse who has conducted the school-based immunisation program on the same day that students participated in the study.
2.The participant has given informed consent.
3.The participant is willing and able to participate in an interview.

School personnel:
1.The participant is employed at a school participating in the study (including school health nurses, teachers and student support staff) and has provided student supervision on the vaccination day during which students completed the study.
2.The participant has given informed consent.
3.The participant is willing and able to participate in an interview.
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students:
1.The participant is not receiving any vaccinations at school as part of the school-based immunisation program.
2.English language literacy has been identified as insufficient to complete the questionnaire.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Completed
Date of first participant enrolment
Anticipated
24/08/2015
Actual
15/10/2015
Date of last participant enrolment
Anticipated
17/03/2016
Actual
17/03/2016
Date of last data collection
Anticipated
Actual
17/03/2016
Sample size
Target
126
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291764 0
Charities/Societies/Foundations
Name [1] 291764 0
Princess Margaret Hospital Foundation
Country [1] 291764 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Road
SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 290432 0
None
Name [1] 290432 0
Address [1] 290432 0
Country [1] 290432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293284 0
Princess Margaret Hospital Human Reserach Ethics Committee
Ethics committee address [1] 293284 0
Ethics committee country [1] 293284 0
Australia
Date submitted for ethics approval [1] 293284 0
Approval date [1] 293284 0
17/07/2015
Ethics approval number [1] 293284 0
2015055EP

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

Contacts
Principal investigator
Name 59246 0
A/Prof Peter Richmond
Address 59246 0
Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS WA 6009
Country 59246 0
Australia
Phone 59246 0
+61 8 6456 5699
Fax 59246 0
Email 59246 0
[email protected]
Contact person for public queries
Name 59247 0
Jane Jones
Address 59247 0
Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, NEDLANDS WA 6009.
Country 59247 0
Australia
Phone 59247 0
+61 8 6319 1849
Fax 59247 0
Email 59247 0
[email protected]
Contact person for scientific queries
Name 59248 0
Peter Richmond
Address 59248 0
Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS WA 6009
Country 59248 0
Australia
Phone 59248 0
+61 8 6456 5699
Fax 59248 0
Email 59248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.