Acceptability of a virtual reality tour for patients referred for their first PET-CT scan
| ISRCTN | ISRCTN54147382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54147382 |
| IRAS number | 318986 |
| Secondary identifying numbers | IRAS 318986, CPMS 55006 |
- Submission date
- 02/08/2023
- Registration date
- 04/09/2023
- Last edited
- 18/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Every year a small percentage of patients that are referred for a PET/CT are unable to complete the procedure due to claustrophobia-induced and procedure-related anxiety. As PET/CT involves the use of a radioactive tracer, patients that have the injection but then fail to finish the scan due to anxiety will receive the radiation detriment for no benefit. Most patients will have some form of anxiety when having their first PET-CT scan and so an intervention that would help alleviate procedural anxiety and improve the patient experience is welcomed. The project proposed will investigate whether a virtual tour constructed from 360 videos of the PET suite, and procedures that the patient would undergo (Virtual Reality (VR) intervention), displayed on a VR Headset, could be used to reduce procedure-related anxiety and improve the patient experience. The Virtual Tour (VT) is very much like the VTs that estate agents use to showcase properties. This is a pilot study; therefore, the primary aim is to assess the acceptability and feasibility of the VT tour for any patient having their first PET-CT and collect data on anxiety before and after the VT. This pilot will inform and appropriately power a larger trial (multi-centre) and provide additional information to existing knowledge in the literature.
Who can participate?
Adult patients attending a PET/CT scan
What does the study involve?
Anxiety will be measured using a non-validated anxiety measure before and once again after the intervention. The second measure will be taken before the patient's actual PET/CT scan. Heart rate will also be measured during the VT and during the actual PET-CT scan. These will be compared to see if the mean heart rate is reduced when compared to the VT mean heart rate. An interview is conducted a day or two after the PET-CT scan to gather information on the participant's experience, which will be used to further improve the VT.
What are the possible benefits and risks of participating?
The researchers are conducting this trial to see if our current prototype is acceptable and if there is a potential benefit in reducing anxiety directly regarding the scan. They do not know if the VT will reduce a patient’s anxiety, which is why they are doing this study. It is hoped that the information from this study will help to improve the care of people who are anxious about PET/CT scans.
It is very unlikely that a participant would be harmed by taking part in this research. As the VR tour simulates the PET/CT experience, it is possible that it may make them feel anxious. Motion sickness from the VT is also a possibility, however, the tour has been designed to mitigate this risk and include mostly static viewpoints.
Where is the study run from?
Churchill Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2022 to June 2023
Who is funding the study?
Oxford University Hospitals NHS Foundation Trust (UK)
Who is the main contact?
Mr Michael Barnard, michael.barnard@ouh.nhs.uk
Contact information
Principal Investigator
Radiation Physics and Protection
Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom
 ORCID ID |
0000-0002-6880-5687 |
|---|---|
| Phone | +44 (0)1865 235338 |
| daniel.mcgowan@ouh.nhs.uk |
Scientific
Radiation Physics and Protection, Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom
| ORCID ID |
0000-0003-3323-1158 |
|---|---|
| Phone | +44 (0)1865235333 |
| michael.barnard@ouh.nhs.uk |
Study information
| Study design | Single-centre pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Feasibility study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 44048_PIS_V1.1_Jan23.pdf |
| Scientific title | Feasibility study on the acceptability of a virtual reality tour for patients referred for their first PET-CT scan |
| Study acronym | PET-CT VR Tour HR |
| Study objectives | That the current prototype virtual tour is acceptable to patients. A virtual tour of the PET-CT pathway observed by patients before their actual first PET-CT, reduces their heart rate during the real PET-CT compared with their heart rate during the virtual tour PET-CT. |
| Ethics approval(s) |
Approved 27/02/2023, London - Dulwich REC (HRA, Skipton House, 80 London Road, London, SE1 6LH, United Kingdom; +44 (0)2071048094; dulwich.rec@hra.nhs.uk), ref: 23/LO/0050 |
| Health condition(s) or problem(s) studied | Reduction of procedural anxiety |
| Intervention | All participants have the Virtual Tour (VT). All participants are given a non-validated Anxiety Questionnaire after informed consent and eligibility. During the VT their heart rate is measured. 10 minutes before their actual appointment time, the Anxiety questionnaire is completed again. Heart rate is monitored also during the actual PET-CT scan. An interview is conducted after at least 1 day to gather information to improve the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Heart rate measured using an optical sensor during virtual tour PET-CT bore experience and real PET-CT experience 2. Acceptability and experience of the intervention measured using interviews from Day 2 onwards |
| Secondary outcome measures | 1. Anxiety measured using Anxiety Questionnaire scoring at baseline and after the intervention (10 min before PET-CT appointment time) |
| Overall study start date | 01/12/2022 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Participants aged over 18 years old 2. Participant is willing and able to give informed consent for participation in the study 3. Participant has the required visual acuity to view the VR Tour 4. Participant has the manual dexterity to use the controller |
| Key exclusion criteria | 1. Participant has received a PET/CT scan previously 2. Participant has a hearing impairment which means they cannot hear speech on the tour application 3. Participants who are unable to communicate clearly in English over the telephone for 30 minutes 4. Participants who are unable to understand written English 5. Participant has limited mobility and is unable to position themselves with minimal assistance onto a bed |
| Date of first enrolment | 27/02/2023 |
| Date of final enrolment | 28/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
Second Floor
OUH Cowley
Unipart House Business Centre
Oxford
OX4 2PG
England
United Kingdom
| Phone | +44 (0)1865 572231 |
|---|---|
| ouhtma@ouh.nhs.uk | |
| Website | http://www.ouh.nhs.uk/ |
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Oxford University Hospitals National Health Service Trust, OUH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in European Radiology and appropriate conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. Data sharing is only available in the NHS Trust where the study is taking place and for the regulatory authorities. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 01/01/2023 | 02/08/2023 | No | Yes |
Additional files
Editorial Notes
18/06/2024: The intention to publish date was changed from 30/06/2024 to 31/12/2024.
04/10/2023: Internal review.
02/08/2023: Study's existence confirmed by the HRA.
