The effect of virtual reality versus standard-of-care treatment on pain perception during paediatric vaccination: Study protocol for a randomised controlled trial.

Aims And Objectives: To study the effects of virtual reality (VR) on pain perception among a paediatric population while being vaccinated. We will also investigate the effects of VR on the fear experienced by children during the vaccination procedure, as well as parental satisfaction levels.

Background: Many studies, for example, in the fields of oncology, dermatology or plastic surgery, have described the benefits of using VR to reduce the perception of pain among paediatric populations. These results are encouraging, but their main limitations were the small sample sizes they included or their methodological design.

Design: This will be a randomised clinical trial.

Methods: SPIRIT guidelines were followed to report this protocol, and we will use the CONSORT and CONSORT-EHEALTH guidelines to report the randomised clinical trial. The sample will comprise 148 children aged 3-14 years who will come for vaccination at the Tres Forques Health Center. The participants will be randomly allocated into intervention group (VR; n = 74) or (the control group standard-of-care; n = 74) at a 1:1 ratio. The intervention group will view experiences with a VR headset as a distraction measure. The study variables will be the level of pain and fear perceived by the child during vaccination, parental satisfaction with the vaccination procedure, and sociodemographic and vaccination variables.

Results: The start of the study is planned for September 2020, and the results will be expected in September 2021.

Conclusions: This study aims to identify what measures reduce pain and fear in children during vaccination, which in turn, can help to improve the degree of parental satisfaction with these procedures.

Relevance To Clinical Practice: Vaccination is an independent function of the nursing profession. Identifying which distraction measures reduce the perception of pain and fear in the paediatric population will not only improve children's experiences but will also improve the satisfaction of both parents and children, thus increasing the degree of compliance with the vaccination schedule.