Title: No need(le) to worry: Development and feasibility study of a self-help cognitive behavioural therapy resource for children with needle fear
Funder: Department of Health and Social Care

Abstract: TitleNo need(le) to worry: Development and feasibility study of a self-help cognitive behavioural therapy resource for children with needle fear.The problemNeedles are utilised frequently throughout childhood to provide inoculations, to take blood samples to aid investigations, and to administer medications intramuscularly or intravenously. Needle fear is common, affecting up to 50% of the child population. Needle fear can be viewed as a continuum from mild fear to extreme fear and phobia. All children and young people with needle fear will have physiological symptoms and emotional responses to needles and may employ avoidance tactics. However, where there is significant distress and interference to their lives, this would be classed as a phobia.Fear of needles can lead to the delay or even avoidance of necessary healthcare interventions which can result in poorer health and poorer outcomes, including quality of life. It can be a life-long problem, not just for the individual but also for their family. There are limited resources currently available to reduce needle fear in children. Cognitive behavioural therapy (CBT) has been shown to be effective in the treatment of anxiety disorders and specific phobias and recent studies have shown that self-help CBT resources can also be effective in reducing dental anxiety. Despite the acknowledged efficacy of CBT, there is a paucity of evidence related to the use of self-help CBT in managing needle fear. However, given the strong evidence-base for CBT, it is reasonable to assert that an intervention of this nature could be invaluable in helping children manage their fear of needles in many contexts.AimTo develop and undertake a feasibility study of a self-help CBT resource for children with needle fearPlanThe project will comprise two main stages:Stage 1 will involve children aged 11-16 years, their parents, and healthcare providers in the co-design of a self-help CBT resource to reduce children's needle fear. This will involve qualitative interviews with around 20 children with a variety of needle related fears and experiences, and subsequent workshops with children, parents and healthcare providers to co-design the resource. Stage 2 will be an uncontrolled feasibility study focusing on recruitment and retention of participants, acceptability of the resource and testing alternative outcome measures.The feasibility study will address these key uncertainties: a. The most appropriate self-report measure of needle fear, which will be the primary outcome for a future trialb. The perception of key stakeholders, such as phlebotomists, dentists, anaesthetists, research nurses of such a resource, and their willingness to recruit participantsc. Retention and completion ratesd. Acceptability of the developed resource to children and their parents, and their willingness to be recruitedFindings from this feasibility study are essential for the justification and planning of a future randomised controlled trial to reduce needle fear in children, using a self-help CBT approach, with wide impact for paediatric healthcare users and providers.

Lay abstract: Needles are used frequently throughout childhood to provide essential vaccinations, take blood samples and give medicines. Needle fear is very common, with around 50% of children and young people reporting that they are worried about needles. Being worried about needles can mean that people avoid or delay going to the doctor or dentist, refuse immunisations and this can cause them to have pain, infections or become unwell. Fear of needles prevents children from being able to have the treatment they need to improve their health. Health care professionals regularly see children who are so distressed at the thought of a needle that they avoid appointments or require a general anaesthetic for their treatment. Although there are currently some needle fear resources, such as leaflets and videos, which children and young people can access through the internet, there are no resources which have been developed with children and young people themselves based on approaches that are known to be effective. It is very important that children and young people are engaged in developing resources aimed at them, to ensure they are in an acceptable format and contain information that they actually find helpful. The resources which currently exist have been made by adults and may not be helpful to children. Children and young people who have generalised or specific anxiety can be helped by a talking therapy called Cognitive Behavioural Therapy, or CBT for short. In view of limited services, CBT delivered by professionals is only offered to children who are extremely frightened of needles. Many more children would benefit if a resource based on CBT was available to help them feel less worried about needles. Part of this project will be to make a resource that children and young people and their parents can use at home. The resource will be developed with children and young people and will use some of the same techniques as CBT. The overall aim of the project is to develop a resource to reduce fear of needles in children and young people and investigate whether a clinical trial to evaluate it would work. The project will be conducted in two stages. The first stage involves the development of the resource and will be informed by interviews about needle fear with around 20 children aged 11-16 years old (who have experience of different kinds of needles) and 20 parents. This will gain a real understanding about the factors that cause and maintain needle fear, such as beliefs or unhelpful ways of coping, which can then be addressed in the resource. It will help identify what the resource should include, and how children would like to interact with it. The resource itself will then be created with the help of a group of children, parents and healthcare workers. The second stage of the project will investigate whether a clinical trial to evaluate the resource will be feasible. Healthcare professionals from local dental practices, hospitals and schools will recruit sixty children who are worried about needles and invite them to use the resource (which may be a website or app). This stage will help decide how best to measure children's fear of needles, and to understand how easy it would be to recruit children to take part in a larger project to test this resource in the future. This stage will also investigate what these children think of the resource, and how it could be improved. The views of their parents and healthcare professionals about the resource will be sought. This small study will help to plan a larger study which will show whether the resource works.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH