Protocol for a feasibility study of a self-help resource based on the principles of cognitive behavioural therapy to reduce needle fear in young people aged 11- to 16 years

Abstract Background Needle fear affects up to half of all young people, with the potential to impede their accessing and acceptance of healthcare interventions. There is presently a lack of accessible self-help resources available to support young people in managing needle-based procedures. This feasibility study aims to create a trial protocol for future definitive assessment of a self-help tool co-designed with young people, to manage their fear of needles. Methods This article presents the protocol for a study to evaluate the feasibility of a future definitive randomised trial, and broad acceptability of a developed self-help resource. In total sixty children aged 11–16 years will be recruited from across three sites (secondary dental care, secondary medical care and a school setting) and directed to complete the proposed outcome measures and access a self-help resource developed by the authors in collaboration with young people, parents and healthcare professionals in order to test feasibility. Additionally, a subset of 20 children will be invited to participate in qualitative interviews following their involvement in the feasibility phase to explore their experiences, any key facilitators or barriers, and their general acceptance of the resource. This study will address key uncertainties around recruitment of sites and participants, and variability of outcome measures, prior to a definitive future trial. Discussion The resource was developed in collaboration with young people, parents and healthcare professionals. This self-help resource has the long-term potential to benefit young people through support in managing their fear of needles. This study will provide methodological evidence to support a future definitive trial evaluating the effectiveness of the resource.