None listed
Conditions
Brief summary
This study aims to reduce student experience of pain, fear and anxiety associated with school-based vaccinations. Our previous research in Perth, Adelaide and Sydney has identified that needle related anxiety is a common experience, and that for some adolescents vaccination can be very distressing. This study will determine if using an iPad application (‘app’), called BrightHearts, during the school vaccination process can improve this experience for students. It will also explore feasibility, acceptability and implementation issues associated with students using the app in this setting. BrightHearts is an award-winning artwork and mobile ‘app’, (2012 Australian Business Arts Foundation: Arts and Health Foundation Award, and 2012 National New Media Art Award, Queensland Art Gallery) developed at The Children’s Hospital at Westmead, NSW, for the purpose of teaching children relaxation techniques to cope with pain. It uses an iPad to display a colourful geometric artwork and also plays musical sounds that respond to changes in heart rate transmitted by a wireless pulse monitor worn on the child’s earlobe. Decreases in heart rate animate the sounds and visuals on the app, which is achieved by focusing on relaxing thoughts and taking big slow breaths. This gives the child feedback that their body is more relaxed. We will be inviting at least 120 Year 8 students from three schools in WA to trial the BrightHearts app during a routine school vaccination day. Students will be assigned by chance to either use the BrightHearts app or to be vaccinated without the app (as would usually occur). After vaccination we will ask all students to complete a short questionnaire on an iPad. Students will be asked questions about how they usually feel and how they felt before and during vaccination, including whether they experienced any pain, fear or anxiety. If they used the BrightHearts app they will also be asked what they thought about this. Researchers will also observe the school vaccination days and invite one immunisation nurse and one school staff member from each school to participate in an interview, which will assist in understanding whether BrightHearts is useful and to identify any implementation issues.
Interventions
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
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.
Sponsors
Princess Margaret Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
12 Years to 14 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed