Colo-rectal SurgeryVR-RAPNCT07274098
To Test Effectiveness of Virtual Reality on Post Operative Patients 'VR-RAP@
A study testing Virtual reality in people with Colo-rectal Surgery, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Virtual reality (VR) headsets (like those used in gaming) allow users to feel immersed in an artificial 3 dimensional environment. The user is able to look around within the environment and interact with it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Surgery
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2025to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and above Having elective laparoscopic colorectal surgery Patients who are able to understand English and can understand the Participant Information Sheet and give informed consent to take part in the study.
Who cannot join
- presence of motion sickness
- stroke
- Severe nausea
- isolation status for infection control
- neurological conditions i.e. dementia, seizure, epilepsy
- Suffering from delirium or acute confusional state
Show all 11Show fewer
- Skin on face or head is broken i.e. head wounds or dermatological conditions
- Conversion to open surgery, if decided prior to consent
- Patients with severe visual impairment (i.e., not able to clearly see without glasses; patients with contact lenses will not be excluded).
- Inclusion in another trial to evaluate new ways of treating pain
- Use of strong opioids (i.e., morphine)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kent and Canterbury Hospital
Canterbury, Kent, CT1 3NG
About this study
Official title: A Randomised Controlled Pilot Study of the Effectiveness of a VR Headset on Post Operative Relaxation, Anxiety and Pain in Patients Undergoing Elective Laparoscopic Colorectal Surgery
Virtual reality (VR) headsets (like those used in gaming) allow users to feel immersed in an artificial 3 dimensional environment. The user is able to look around within the environment and interact with it.
Virtual reality has been used extensively in video games and also in training eg in flight simulators used to train pilots.
Read more
There is now a growing use of VR in a clinical setting as virtual reality environments have been designed to help users relax and reduce anxiety or distract and reduce pain. Trials have shown that these can work in many situations including helping relax staff who are working in highly stressful situations, or to distract and help reduce pain in patients following injuries or during minor operations. The relaxation environments use pictures and sounds to create calm environments and can guide users in breathing exercises which help calm and relax. This study is to investigate whether it will be possible to do a study using a VR headset with a relaxation experience, in the days following abdominal surgery that leads to a reduction in anxiety and pain.
Two groups of patients will be studied, one group will use the head set twice a day for up to 5 days and the other will not. They will record their pain and anxiety on a scale of 1 to 10 every day. The amount of pain reducing medicines that they need will also be recorded. The patients will be randomly divided into the 2 groups, they will not get to choose.
The researchers will see whether patients are happy to use the headsets following surgery and at the end of the study, the pain and anxiety scores for the group which used the VR headset will be compared with the scores for the group that didn't.
Read the detailed description
Potential participants will be identified within the Multi Disciplinary Team (MDT) meetings and review of theatre lists by the Chief Investigator or the relevant delegated research staff. They will be approached before surgery by a member of the research team (who are part of the clinical care team) when they have their pre-assessment appointment or contacted when they have been deemed eligible .
If they are interested in being involved in the study they will be given a copy of the Participant information sheet (PIS) and given the opportunity to ask any initial questions. Patients will have ample time and opportunity to review and consider the PIS In the days prior to surgery they will be contacted to see if they would like to take part and ask any questions.
If they do want to take part, they will give consent to a member of the research study team any time before surgery.
Once consented, the participants will be shown how to use the equipment and the relaxation courses that are available . This will take place in hospital either at an appointment or on day of surgery The participant will be randomised on the day of surgery to either standard of care (SOC) or VR. Randomisation will not take place before the day of surgery in case the surgery is cancelled or doesn't go ahead for other reasons.
On the day of surgery, before surgery, all participants will complete a questionnaire, , about their mood, anxiety levels and pain score using visual analogue scales (VAS). This will be the baseline data.
Data will be collected on the day of surgery post surgery and from day 1 after surgery. Ideally this will be before the ward drug round. This will ensure that the effect on pain levels of using VR can be fairly measured. Data will be collected on Pain score, Anxiety levels, medication required. If randomised to VR then the patient will wear the unit twice a day, morning and afternoon, if possible, before the ward drug round, for a maximum of 5 days whilst they are in hospital. The number of days will depend on the length of time the participant is in hospital post surgery. All participants will complete a questionnaire where they will also be asked about their mood, anxiety levels and pain score using visual analogue scales (VAS) twice a day, morning and afternoon, until discharge or for a maximum of 5 days whilst they are in hospital. Those randomised to the VR arm will also be asked which scenario they watched, for how long and how comfortable they found the headset On day 14 (+/- 1)after surgery, when most participants should have returned home, they will be contacted and asked to complete the questionnaires for a final time.
- Conditions
- Colo-rectal Surgery
- Being tested
- Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
If randomised to VR then the patient will wear the unit twice a day, morning and afternoon, if possible, before the ward drug round, for a maximum of 5 days whilst they are in hospital. The number of days will depend on the length of time the participant is in hospital post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | This arm received Standard care |
| Virtual Reality | Experimental | This arm receives the VR intervention Virtual Reality Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days)
Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days)
Measured: (i.e. twice per day until discharge; maximum 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start16 Apr 2025
- Primary completion9 Jun 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274098
- Sponsor's protocol ID
- 338543
- Acronym
- VR-RAP
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Pilot Study of the Effectiveness of a VR Headset on Post Operative Relaxation, Anxiety and Pain in Patients Undergoing Elective Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07274098
- Acronym / sponsor ID
- VR-RAP / 338543
- Conditions
- Colo-rectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Virtual reality (VR) headsets (like those used in gaming) allow users to feel immersed in an artificial 3 dimensional environment. The user is able to look around within the environment and interact with it.
Virtual reality has been used extensively in video games and also in training eg in flight simulators used to train pilots.
There is now a growing use of VR in a clinical setting as virtual reality environments have been designed to help users relax and reduce anxiety or distract and reduce pain. Trials have shown that these can work in many situations including helping relax staff who are working in highly stressful situations, or to distract and help reduce pain in patients following injuries or during minor operations. The relaxation environments use pictures and sounds to create calm environments and can guide users in breathing exercises which help calm and relax. This study is to investigate whether it will be possible to do a study using a VR headset with a relaxation experience, in the days following abdominal surgery that leads to a reduction in anxiety and pain.
Two groups of patients will be studied, one group will use the head set twice a day for up to 5 days and the other will not. They will record their pain and anxiety on a scale of 1 to 10 every day. The amount of pain reducing medicines that they need will also be recorded. The patients will be randomly divided into the 2 groups, they will not get to choose.
The researchers will see whether patients are happy to use the headsets following surgery and at the end of the study, the pain and anxiety scores for the group which used the VR headset will be compared with the scores for the group that didn't.
Detailed description
Potential participants will be identified within the Multi Disciplinary Team (MDT) meetings and review of theatre lists by the Chief Investigator or the relevant delegated research staff. They will be approached before surgery by a member of the research team (who are part of the clinical care team) when they have their pre-assessment appointment or contacted when they have been deemed eligible .
If they are interested in being involved in the study they will be given a copy of the Participant information sheet (PIS) and given the opportunity to ask any initial questions. Patients will have ample time and opportunity to review and consider the PIS In the days prior to surgery they will be contacted to see if they would like to take part and ask any questions.
If they do want to take part, they will give consent to a member of the research study team any time before surgery.
Once consented, the participants will be shown how to use the equipment and the relaxation courses that are available . This will take place in hospital either at an appointment or on day of surgery The participant will be randomised on the day of surgery to either standard of care (SOC) or VR. Randomisation will not take place before the day of surgery in case the surgery is cancelled or doesn't go ahead for other reasons.
On the day of surgery, before surgery, all participants will complete a questionnaire, , about their mood, anxiety levels and pain score using visual analogue scales (VAS). This will be the baseline data.
Data will be collected on the day of surgery post surgery and from day 1 after surgery. Ideally this will be before the ward drug round. This will ensure that the effect on pain levels of using VR can be fairly measured. Data will be collected on Pain score, Anxiety levels, medication required. If randomised to VR then the patient will wear the unit twice a day, morning and afternoon, if possible, before the ward drug round, for a maximum of 5 days whilst they are in hospital. The number of days will depend on the length of time the participant is in hospital post surgery. All participants will complete a questionnaire where they will also be asked about their mood, anxiety levels and pain score using visual analogue scales (VAS) twice a day, morning and afternoon, until discharge or for a maximum of 5 days whilst they are in hospital. Those randomised to the VR arm will also be asked which scenario they watched, for how long and how comfortable they found the headset On day 14 (+/- 1)after surgery, when most participants should have returned home, they will be contacted and asked to complete the questionnaires for a final time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –This arm received Standard care |
| Virtual Reality | Experimental | Device: Virtual realityThis arm receives the VR intervention Virtual Reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 18 years and above Having elective laparoscopic colorectal surgery Patients who are able to understand English and can understand the Participant Information Sheet and give informed consent to take part in the study.
Key exclusion criteria (11 listed)
- presence of motion sickness
- stroke
- Severe nausea
- isolation status for infection control
- neurological conditions i.e. dementia, seizure, epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityIf randomised to VR then the patient will wear the unit twice a day, morning and afternoon, if possible, before the ward drug round, for a maximum of 5 days whilst they are in hospital. The number of days will depend on the length of time the participant is in hospital post surgery. | Device | Virtual Reality |
Primary outcome
Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days)
Time frame: (i.e. twice per day until discharge; maximum 5 days)
Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Colo-rectal Surgery
Not yet recruiting
NURSE-led Geriatric Assessment in Older Colorectal Cancer Patients
Colo-rectal Cancer
Not yet recruiting
Megagon Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses
Colo-rectal Anastomosis
Recruiting
Prehabilitation in High-risk Oncologic Surgery
Pancreatic Cancer, Colo-rectal Cancer
Not yet recruitingObservational study
Early Discharge After Colorectal Surgery
Cancer, Colo-rectal Cancer
RecruitingPhase 2
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
Colo-rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Colo-rectal Surgery, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days) (time frame: (i.e. twice per day until discharge; maximum 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.