A controlled trial of a virtual reality experience to support wellbeing in healthcare students

ISRCTN ISRCTN51742331
DOI https://doi.org/10.1186/ISRCTN51742331
Submission date
23/04/2025
Registration date
06/05/2025
Last edited
28/04/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study compares a virtual reality experience aimed at relieving stress in students with the same experience on the students' phones.

Who can participate?
Adult students enrolled at St George's University of London.

What does the study involve?
Participants were randomised into the two groups and received either phone or VR experience every day for five days. Measures of wellbeing, stress and depression were recorded before and after the five days, and students filled out scales about their stress levels before and after each experience. They were asked at the end of the study about their views of what was positive and what was negative about it.

What are the possible benefits and risks of participating?
The benefits of participating were to experience the app, and students were remunerated. The risks were of "cybersickness", which is like motion sickness.

Where is the study run from?
St George's University of London, UK

When is the study starting and how long is it expected to run for?
July 2022 to January 2024

Who is funding the study?
National Institute of Health and Care Research (NIHR)

Who is the main contact?
Dr Aileen O'Brien, aobrien@sgul.ac.uk

Contact information

Dr Aileen O'Brien
Public, Scientific, Principal Investigator

St George's, University of London
Cranmer Terrace
Tooting
London
SW17 ORE
United Kingdom

ORCiD logoORCID ID 0000-0002-2824-7190
Phone +44 (0)7961174521
Email aobrien@sgul.ac.uk

Study information

Study designUnblinded parallel-group randomized controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)University/medical school/dental school
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleA controlled trial of a virtual reality experience to support wellbeing in healthcare students
Study objectivesA VR intervention delivered over 5 consecutive days can reduce subjective levels of stress, anxiety and depression and improve wellbeing in healthcare students in a university setting with baseline, post-intervention and 2-week follow-up measures compared to the same intervention delivered on a smartphone.
Ethics approval(s)

Approved 03/07/2023, St George's University of London Ethics Committee (Joint Research and Enterprise Services Ground Floor, Jenner Wing St. George’s, University of London, Cranmer Terrace, Tooting, London, SW17 ORE, United Kingdom; +44 (0)2087255000; sgulREC@sgul.ac.uk), ref: 2023.0136

Health condition(s) or problem(s) studiedAnxiety/stress
InterventionOverview
The study employed an unblinded, parallel randomised controlled trial (RCT) design with university students. A clinically informed multi-sensory hypnotherapy-based experience using an immersive VR app designed to reduce symptoms of anxiety and stress was compared with the same experience watched on a smartphone and listened to through headphones (video condition). This was delivered over five days with a two-week follow-up. Wellbeing, perceived stress, and depression measures were completed to enable comparison of the two conditions. Qualitative data were obtained through open-text responses in a brief semi-structured questionnaire, capturing the subjective experiences of students.

Participants and setting
The study took place at St George’s, University of London (SGUL), the only specialist healthcare university in the UK, with 5500 full-time students on a range of healthcare courses: medicine, physiotherapy, diagnostic and therapeutic radiography, physician associate and paramedic science. In 2023, 60% of the students were female, 11% Black, 33% Asian, 9% other/mixed and 46% White. All students enrolled at SGUL, regardless of course and level of entry, were offered the opportunity to take part in the study and were recruited over one month (October-November 2023). They were informed via the Student Union (SU) social media and invited to register on the study website. Students with a history of seizures or a pacemaker were excluded due to known risks of immersive VR with these presentations. There were no other exclusion criteria; a deliberate decision was made not to exclude students with mental health concerns. 131 participants were recruited and randomly allocated to VR (n=67) or video (n=64). Participants received sixty pounds as remuneration.

Randomisation
The randomisation schedule was generated using freely available software (Sealed Envelope Ltd. 2022) by a member of the research team. Randomly permuted blocks with block sizes of 2, 4 or 6 were utilised. After students were recruited into the study and had completed the initial baseline questionnaires, they were informed of their randomised allocation. No further blinding of students or researchers was possible.

Procedure
Two conference rooms in the Students’ Union were used for VR sessions. Students allocated to the VR experience were brought into one room in groups of five. Slots were available for students to attend from 10 am-12 pm and again from 2 pm-4 pm. A facilitator demonstrated the use of the Meta Quest 2 VR headset, then each of the students took part in the VR experience. A quiet, comfortable and safe space was maintained throughout the experience. For students allocated to the video experience, tables were set up at spaced intervals in a second room, with a facilitator present to maintain silence. Students were able to use their own headphones or the headphones that were provided. QR codes were available at each table for students to access the video experience on their smartphones, and QR codes were provided to all students to complete Visual Analogue Scales, measuring immediate effect, before and after the experience.

Intervention and control conditions
The intervention arm consisted of a daily experience of one of a series of 5 clinically informed VR hypnotherapy experiences designed by Phase Space to reduce exam stress. Each of the experiences, which were designed with students in mind, lasted approximately seven minutes. Each participant was given verbal guidance and suggestions within the immersive multi-sensory experiences, combining soothing visuals, sounds and music. The audio is augmented with generative VR graphics beginning in a domed hall. The user was gently guided through a transition into darkness before rings of brightly shining particles started to form and begin to travel towards the viewer, passing around them on all sides before fading. The synchronicity and timing of these particle rings, combined with gentle pulses, aid suggestion to slow the breath. The user is given additional guidance to reduce tension in the body and calm the mind with a clinically informed selection of positive suggestions before they are gradually brought back to the domed hall. The viewer is then grounded in the present moment and asked to remove their headset when they are ready, as the experience finishes. The control arm consisted of the same daily experiences that were delivered by smartphone and listened to with headphones without an immersive component.
Intervention typeBehavioural
Primary outcome measure1. Momentary negative and positive affective states, and participants’ level of immersion were measured using a 10-point numerical analogue scale (VAS) at baseline and a 2-week follow-up
2. Cybersickness was measured using the Simulator Sickness Questionnaire (SSQ) before and after the intervention on the final trial session
3. The following short-term outcomes in perceived stress, wellbeing, and depressive symptoms measures using standardised questionnaires at baseline and a 2-week follow-up:
3.1. Global perceived level of stress was measured with the 10-item version of the Perceived Stress Scale (PSS)
3.2. Positive states of being, thinking, behaving and feeling in the last 2 weeks were measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
3.3. Depression symptoms were measured using the Patient Health Questionnaire-2 (PHQ2)
4. Intervention satisfaction: At the end of the trial, participants were asked which group they would have preferred to be in. Satisfaction with the intervention for participants completing VR or Video interventions was measured using the VAS, measuring levels of agreement (with anchors 1=‘do not agree’, 10=‘totally agree’) that the experience made them feel calmer, had a positive effect and is one they would recommend to other students. Participants were also asked to describe the impact the experience had on them personally, if it is something they could see themselves using and to provide any other comments/feedback in an open-ended manner. At 2-week follow-up, participants rated levels of agreement (on VAS scales) that the intervention helped to manage stressful situations and is a resource they would see themselves using in the future.

Secondary outcome measuresUse of mental health and support services measured using a study questionnaire at baseline, post-intervention and 2-week follow-up
Overall study start date19/07/2022
Completion date21/01/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants120
Total final enrolment131
Key inclusion criteria1. Over the age of 18
2. Enrolled student at St George's University of London
Key exclusion criteria1. History of seizures
2. History of pacemakers
Date of first enrolment06/11/2023
Date of final enrolment20/11/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St George's University of London
Cranmer Terrace, Tooting
London
SW17 ORE
United Kingdom

Sponsor information

St George's, University of London
University/education

Cranmer Terrace, Tooting
London
SW17 ORE
England
United Kingdom

Website https://www.sgul.ac.uk
ROR logo "ROR" https://ror.org/040f08y74

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/06/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and analysed during the current study will be available upon request from Dr Aileen O'Brien,aobrien@sgul.ac.uk. The data are the anonymysed results of the measures described above. They will be available after the time of publication of the paper. All participants consented. Data were anonymised. Ethical approval was granted.

Editorial Notes

28/04/2025: Study's existence confirmed by the St George's University of London Ethics Committee.