BrightHearts: Using biofeedback mediated relaxation techniques during vaccination of adolescents.

INTERVENTION: 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. CONDITION: Vaccine‐related anxiety Vaccine‐related fear Vaccine‐related pain PRIMARY OUTCOME: 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. 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. 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. SECONDARY OUTCOME: 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) 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. 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.