ISRCTN ISRCTN16465718
DOI https://doi.org/10.1186/ISRCTN16465718
IRAS number 346340
Secondary identifying numbers 2024.0197
Submission date
05/05/2025
Registration date
21/05/2025
Last edited
21/05/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Following serious injuries (major trauma), rehabilitation is very important. It helps people regain their strength, movement, and independence. VR is the name for computer technology that makes a person feel like they are somewhere else. More recently, people are using VR through a headset. The headset is worn over a person’s eyes and shows a close-up screen. VR headsets have applications or ‘Apps’ (like on your mobile phone) which offer games, exercises, guided relaxation, or relaxing scenery. VR could help people recover from injuries. It might make rehab more fun and engaging. VR is starting to be used more in healthcare as a way of helping patients recover. But we have lots to learn about the best ways to use it to help patients. Following major trauma, rehabilitation starts early in the acute hospital setting and can be a gruelling process due to pain, fear of movement, post-traumatic stress, and anxiety. There are several physical and mental barriers that patients feel towards rehabilitation in the hospital. After serious injury, patients who are worried about the threat of pain have been shown to have worse outcomes. Exposure to movement is an effective way to lessen patients' fear of moving due to pain. In other health conditions, the use of VR headsets has been shown to decrease anxiety, pain and the time spent thinking about pain. Usually, this is using the relaxing types of VR. Given the benefits of exposure to movement and the importance of not becoming weaker, we want to know if a more physically active VR treatment could be beneficial for patients’ rehabilitation. To the best of our knowledge, there is no research looking at patients’ experience of using VR headsets for rehabilitation following serious injury. The study will explore whether patients find VR headsets helpful and acceptable during their rehabilitation in the hospital. This study aims to find out if using virtual reality (VR) headsets can make rehab better, and what people think of using them in the hospital.

Who can participate?
People aged over 18 years who have experienced major trauma injuries and use VR headsets during their rehab in the hospital

What does the study involve?
Patients who agree to take part will have a 30-minute interview with a researcher, which can be in person or done by video call. They will be asked to sign a consent form and fill in a short form about themselves and their injuries. Patients will be asked about their experiences of using VR headsets during their rehab in the hospital to explore what they liked or didn’t like about them, and if they found them helpful.

What are the possible benefits and risks of participating?
Benefits: The study could help improve rehabilitation for future trauma patients.

Risks: Reflecting on the recovery from serious injuries may be emotionally challenging. They can stop taking part at any time, without giving a reason.

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

When is the study starting and how long is it expected to run for?
August 2024 to September 2025. The study has approval to start in December 2025. Interviews will be conducted within 6 months and the study will be written up by September 2025.

Who is funding the study?
There is no additional funding for the study, it is being conducted as part of a Master's in Clinical Research.

Who is the main contact?
Bethany Kenny, Bethany.kenny@stgeorges.nhs.uk

Contact information

Mrs Bethany Kenny
Public, Scientific, Principal Investigator

Therapies Department, St George's Hospital, Blackshaw Road
London
SW170QT
United Kingdom

ORCiD logoORCID ID 0000-0002-5127-7523
Phone +44 (0)2087250985
Email bethany.kenny@stgeorges.nhs.uk

Study information

Study designQualitative interview study
Primary study designObservational
Secondary study designQualitative interview study
Study setting(s)Home, Hospital, Internet/virtual
Study typeTreatment, Efficacy
Participant information sheet 47278 VR Qualitative Study PIS_Version 2.0_14.01.25_Acceptedethics.pdf
Scientific titlePatients experience and acceptability of using a virtual reality headset as an adjunct to rehabilitation following major trauma: an interview study
Study objectivesTo explore patients’ experience and acceptability of using a physically active VR Headset intervention as an adjunct to their rehabilitation following major trauma via semi-structured interview.
Ethics approval(s)

Approved 16/12/2024, West of Scotland Rec 3 (Admin Building, Level 2, 1055 Great Western Rd, Glasgow, G12 XH, United Kingdom; +44 (0)141 314 0212; ggc.WoSREC3@nhs.scot), ref: 24/WS/0158

Health condition(s) or problem(s) studiedInpatients with major trauma
InterventionCurrently St George's University hospital is running a quality improvement project looking at the use of a physically active VR headset interventions as an adjunction to their rehabilitation. Patients undergo a sessions of VR, up to 30min's. They can play physically active games such as boxing, goal keeping, fruit picking, swiping boxes with a sword in either a sitting lying or standing position. Patients who have experienced this intervention (atleast two times) are being invited to participate in a 30-min semi-structured interviews with the lead researcher. The interview transcript is designed around the transtheoretical framework of acceptability (TFA), This framework posits seven constructs that reflect the underlying key dimensions of acceptability of new healthcare interventions (Affective attitude, Burden, intervention coherence, ethicality, opportunity costs, perceived effectiveness and self-efficacy).
Intervention typeDevice
Pharmaceutical study type(s)Not Applicable
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Sync VR medical, PICO Headset
Primary outcome measure The outcomes will be drawn from thematic analysis of the semi-structured interviews. Intereview we be examined to assess the patients perspective of acceptability of the intervention.
To analyse data relating to acceptability a 2-stage process with be completed. In stage 1, text from the interview transcripts will be deductively coded into the seven TFA constructs to provide the core corpus of data for analysis. In stage 2, text within each construct will be inductively analysed to construct themes that reflect the content and meaning of the data.
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date30/07/2024
Completion date30/09/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants15
Key inclusion criteria1. Participants aged 18 and over
2. Who sustained Major Trauma injuries as per the TARN inclusion criteria, who used a physically active Virtual reality headset as an adjunct to their rehabilitation on the major trauma ward
Key exclusion criteria1. Unable to speak fluent English
2. Those who lack capacity to engage in the formal consent process or where the treating clinicians (e.g. doctor or occupational therapist) feels that there is cognitive impairment present that would impact the patient from engaging in an in-depth semi-structured interview
3. A prisoner or vulnerable adult who will have difficulties organising and attending a face-to-face or over the phone interview safely and conveniently
Date of first enrolment01/02/2025
Date of final enrolment30/06/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St George's University Hospital NHS Foundation trust
Blackshaw Rd
London
SW17 0QT
United Kingdom

Sponsor information

City St George's, University of London
University/education

Cranmer Terrace
London
SW17 0RE
England
United Kingdom

Phone +44 (0)2087254077
Email researchgovernance@sgul.ac.uk
Website https://www.citystgeorges.ac.uk/
ROR logo "ROR" https://ror.org/047ybhc09

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date08/10/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe study will be submitted for academic marking in September 2025 and planned to be submitted for publication in a peer-reviewed journal following this.
Outcomes will be disseminated at national or international conferences.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 14/01/2025 21/05/2025 No Yes
Participant information sheet Consent form 14/01/2025 21/05/2025 No Yes
Protocol file version 2.1 06/02/2025 21/05/2025 No No

Additional files

47278 VR Qualitative Study PIS_Version 2.0_14.01.25_Acceptedethics.pdf
47278 VR_MT_Qualitative_ICF_Version2.0_14.01.2025 AcceptedEthics.pdf
Consent form
47278 VR Qualitative Study Protocol_V2.1_06.02.25_AcceptedEthics.pdf

Editorial Notes

06/05/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)