Evaluating an automated virtual reality therapy for needle fears in adolescents
| ISRCTN | ISRCTN74002253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74002253 |
| IRAS number | 334022 |
| Secondary identifying numbers | IRAS 334022, PID17233 |
- Submission date
- 01/08/2024
- Registration date
- 06/08/2024
- Last edited
- 18/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
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.
Who can participate?
Adolescents aged 12 - 15 years old (inclusive) with a needle fear.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
The University of Oxford (UK) is running the study. Oxford Health NHS Foundation Trust, Berkshire Healthcare NHS Foundation Trust, and Buckinghamshire Healthcare NHS Trust are involved in referring patients to the study.
When is the study starting and how long is it expected to run for?
January 2023 to December 2025
Who is funding the study?
The principal funding is from the Beryl Alexander Charity. Support is also received from the NIHR Oxford Health Biomedical Research Centre (UK)
Who is the main contact?
Prof. Daniel Freeman
daniel.freeman@psy.ox.ac.uk
Contact information
Scientific, Principal Investigator
University of Oxford
Department of Experimental Psychology
New Radcliffe House
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0002-2541-2197 |
|---|---|
| Phone | +44 (0)1865 613109 |
| daniel.freeman@psy.ox.ac.uk |
Public
University of Oxford
Department of Experimental Psychology
New Radcliffe House
Radcliffe Observatory Quarter
Woodstock Rd
Oxford
OX2 6GG
United Kingdom
| ORCID ID |
0000-0001-6173-4153 |
|---|---|
| Phone | +44 (0)1865 618261 |
| eve.twivy@psy.ox.ac.uk |
Study information
| Study design | Parallel-group randomized controlled trial with single-blind assessment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, Home, School, Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Virtual reality (VR) for needle fears: a randomised controlled trial of an automated VR therapy for the treatment of needle fears (trypanophobia) in adolescents |
| Study hypothesis | Compared to no treatment, an automated VR therapy will reduce needle fear (end of treatment) for young people with needle fears. |
| Ethics approval(s) |
Approved 26/02/2024, South Central – Oxford B Research Ethics Committee (Health Research Authority, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 1048134; oxfordb.rec@hra.nhs.uk), ref: 23/SC/0420 |
| Condition | Needle fear |
| Intervention | 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). |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | VR for Needle Fears |
| Primary outcome measure | The Injection Phobia Scale- Anxiety (Child Version) at 0, 3, and 6 weeks. |
| Secondary outcome measures | 1. Needle-related disgust reactions measured by the Disgust Emotion Scale for Children – Injections and Blood Draws Subscale at 0, 3, and 6 weeks. 2. Needle-related fearful cognitions measured by the Needle Cognitions Questionnaire at 0, 3, and 6 weeks |
| Overall study start date | 24/01/2023 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Aged 12 - 16 years old (up to 16th birthday) 2. Have significant needle fears that they would like treated (as determined by a screening tool) 3. Willing and able to give assent for participation in the study 4. A parent/guardian is willing and able to give informed consent for their child’s participation in the study |
| Participant exclusion criteria | 1. Photosensitive epilepsy or significant visual, auditory, or balance impairment that would make use of VR inappropriate 2. Current engagement in any other psychological treatment for needle fear 3. Command of English inadequate for engaging in the therapy or completing the assessments 4. 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 |
| Recruitment start date | 04/10/2024 |
| Recruitment end date | 15/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Oxford
OX1 2JD
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
London Road
Bracknell
RG12 2UT
United Kingdom
Sponsor information
University/education
Research Governance, Ethics & Assurance, Joint Research Office, Boundary Brook House, Churchill Drive, Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44(0)1865 616480 |
|---|---|
| RGEA.Sponsor@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/contacts/rgea |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal and conference presentations. |
| IPD sharing plan | Requests - accompanied by a study summary - for sharing of de-identified data will be considered by the Chief Investigator (daniel.freeman@psy.ox.ac.uk) and team. The intent is to share data for reasonable requests. Data will be made available to external researchers subject to the constraints of the consent under which data were collected, with an appropriate data sharing agreement, and after publication of the main study report. |
Editorial Notes
18/02/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 28/02/2025 to 15/07/2025.
2. The overall study end date was changed from 30/04/2025 to 31/12/2025.
19/12/2024: The recruitment end date was changed from 15/12/2024 to 28/02/2025.
04/10/2024: The recruitment start date was changed from 15/08/2024 to 04/10/2024.
01/08/2024: Trial's existence confirmed by NHS HRA.
