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Contact Information:

Dr Eve Twivy
+44 (0)1865 618261
eve.twivy@psy.ox.ac.uk


Prof Daniel Freeman
+44 (0)1865 613109
daniel.freeman@psy.ox.ac.uk


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Be Part of Research - Trial Details - Evaluating an automated virtual reality therapy for needle fears in adolescents
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Evaluating an automated virtual reality therapy for needle fears in adolescents

Recruiting

Open to: All Genders

Age: Child

Oxford Oxford Bracknell Aylesbury

Medical Conditions

Needle fear

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The hypodermic needle may be the most important medical device invented. Billions of needles are used worldwide each year. However, a significant minority of the population are very fearful of needles. This can make medical procedures unpleasant. It can also lead to avoidance of vaccination, blood donation and tests, and uptake of treatments. Fear of needles is especially high in young people. Needle fear can be successfully treated using psychological therapy (graded exposure and applied tension) but because of a shortage of therapists very few people are able to access such help. Working with adolescents with needle fears, we have automated the delivery of evidence-based psychological therapy for needle fear within virtual reality (VR). We now wish to assess the effectiveness for young people of this automated VR therapy for needle fear.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

04 Oct 2024 15 Jul 2025

Interventional

Intervention Type : Device
Intervention Description : Participants (adolescents with significant needle fears) will be randomised to receive the VR therapy or the control group (Treatment as usual, which is typically no treatment). Participants will be allocated to one of the trial arms using a 1:1 allocation ratio. Randomisation will use a permuted blocks algorithm, with randomly varying block size. Assessments will be conducted at 0, 3 (end of treatment), and 6 weeks by a research assistant blind to group allocation. The assessments involve the participant completing questionnaires relevant to assessing their needle fear. We will offer the VR therapy to participants in the control arm after completion of the 6-week follow-up assessment.

The treatment being tested is an automated VR therapy for needle fears. This software is intended to reduce needle fears. It is a cognitive-behavioural exposure and applied tension intervention. The programme takes approximately three hours to complete. The treatment content was designed by the Oxford Cognitive Approaches to Psychosis (O-CAP) research group at the University of Oxford, with young people with lived experience taking part in the design process. The treatment was programmed by the University of Oxford. The VR application has UKCA marking as a Class I Medical Device (Software as a Medical Device).



Adolescents aged 12 - 15 years old (inclusive) with a needle fear.

You can take part if:



You may not be able to take part if:


1. Photosensitive epilepsy or significant visual, auditory, or balance impairment that would make use of VR inappropriate2. Current engagement in any other psychological treatment for needle fear3. Command of English inadequate for engaging in the therapy or completing the assessments4. A participant may also not enter the trial if there is another factor, which, in the judgement of the investigator, would preclude the provision of informed consent/assent or from safely engaging with the trial procedures. Reason for exclusion will be recorded


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Oxford Health NHS Foundation Trust
    Warneford Hospital Warneford Lane Headington
    Oxford
    OX3 7JX
  • University of Oxford
    University Offices
    Oxford
    OX1 2JD
  • Berkshire Healthcare NHS Foundation Trust
    London House London Road
    Bracknell
    RG12 2UT
  • Buckinghamshire Healthcare NHS Trust
    Executive Offices, Hartwell Wing, Stoke Mandeville Hospital, Mandeville Road
    Aylesbury
    HP21 8AL

It is hoped that VR therapy will help people feel less fearful of needles. The study aims to find out whether this is the case. We do not anticipate any significant risks in taking part, however, on rare occasions people may experience motion sickness from using VR. Additionally, some people can feel faint or faint when exposed to needles and therefore participants are seated whilst using the VR.

Dr Eve Twivy
+44 (0)1865 618261
eve.twivy@psy.ox.ac.uk


Prof Daniel Freeman
+44 (0)1865 613109
daniel.freeman@psy.ox.ac.uk



The study is sponsored by University of Oxford and funded by Beryl Alexander Charity; NIHR Oxford Health Biomedical Research Centre.



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Read full details for Trial ID: ISRCTN74002253
Last updated 18 February 2025

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