VRVREMRESDNCT06766162
Virtual Reality to Improve Patient Experience During Endoscopic Mucosal and Submucosal Resection
A study testing Virtual reality pain distraction and Standard analgesia and sedation in people with VR and Virtual Reality Pain Distraction, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study explores the feasibility of using Virtual Reality (VR) to manage pain and anxiety during Endoscopic Mucosal (EMR) and Submucosal Dissection (ESD). EMR and ESD often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VR, Virtual Reality Pain Distraction, Endoscopic Submucosal Dissection
- What is being tested?
- Virtual reality pain distraction and Standard analgesia and sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2025to 1 Jan 2026
- 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
- Age ≥18 years
- Able to consent.
- Fit to use virtual reality.
- Patients allocated to appropriate EMR/ ESD lists.
Who cannot join
- Patients who are unable to consent.
- Contraindication to use VR including, epilepsy and photosensitivity.
- Planned other interventional colonoscopy (Polypectomy, Stenting).
- Visually impaired.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality and Endoscopic Mucosal and Submucosal Dissection: a Patient Centred Experience "VREMRESD"
This study explores the feasibility of using Virtual Reality (VR) to manage pain and anxiety during Endoscopic Mucosal (EMR) and Submucosal Dissection (ESD). EMR and ESD often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. VR, by immersing patients in a calming virtual environment, has shown potential in reducing pain and anxiety in medical settings. This study aims to evaluate its application in improving pain management and reducing sedation use during EMR and ESD.
Read the detailed description
This study utilizes a prospective randomized controlled trial (RCT) design to evaluate the feasibility of incorporating Virtual Reality (VR) as a method for pain management during Endoscopic mucosal and (EMR) Submucosal Dissection (ESD). Participants will be randomized into two groups: one receiving VR sedation with on-demand analgesia and sedation, and the other following standard sedation protocols. The primary endpoint is to assess the feasibility of integrating VR for pain management during EMR or ESD procedures.
Eligibility criteria ensure that participants are suitable for the study. Patients must be 18 years or older, scheduled for EMR ESD, able to provide informed consent, and proficient in English. Those with contraindications for EMR, ESD, severe impairments affecting VR use, or conditions contraindicating VR are excluded. Endoscopists must be experienced in EMR and ESD, willing to participate, and fluent in English, with non-ESD practitioners or those unwilling to participate excluded.
The study aims to enroll 40 patients (20 per group) and involve five experienced endoscopists from the unit, all of whom will be consented. Secondary endpoints include the proportion of EMR and ESD procedures completed using VR, reductions in sedation and analgesia usage, differences in pain scores between the two groups, and satisfaction levels of both patients and endoscopists.
Follow-up will consist of immediate post-procedure feedback and questionnaires to gather insights on VR's impact. This trial will provide critical data on the potential for VR to enhance patient experience, optimize sedation use, and improve procedural outcomes during EMR and ESD, informing future research and clinical applications.
- Conditions
- VR, Virtual Reality Pain Distraction, Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection
- Being tested
- Virtual reality pain distraction, Standard analgesia and sedation
- Keywords
- VRESD, Virtual reality and ESD, VR and endoscopic submucosal dissection, Virtual reeality and endoscopic submucosal dissection, VRWMR, VREMRESD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality pain distractionOther
The intervention group in this study will undergo their EMR and ESD procedure with the addition of virtual reality (VR) as a supportive tool. Participants in this group will use a VR headset during the procedure, designed to provide an immersive experience that may help manage pain and anxiety. The use of VR will be integrated alongside the standard care protocol, including routine sedation and pain management practices VR headset is from DRVR, Rescope innovation which is registered as medical device in the UK.
Standard analgesia and sedationOther
Standard local protocol for analgesia and sedation, incorporating fentanyl and midazolam.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) Arm | Experimental | The VR arm will have a trial run with the VR headset in the endoscopy admission unit. The VR will then be applied at the start of the procedure. If, during the procedure, the patient requests sedation or pain medication, it will be provided. If the patient wishes to remove the VR headset, they may do so at any time. Receives: Other: Virtual reality pain distraction |
| Standard Arm | Active comparator | The control group will follow the standard local protocol for analgesia and sedation throughout the procedure. Receives: Other: Standard analgesia and sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.
This will evaluteed by:
The completed numbers of ESD procedure with the use of the VR as an additive measure to recduce the need for analgesia and sedation.
Measured: During the EMR/ESD procedure
Secondary outcomes (4)
The change in analgesia and sedation used while using the VR.
This will be evaluated by calculating the mean amount of diazepam and fentanyl used in both groups to compare the standard pathway for analgesia and sedation with the VR intervention.
Measured: During the EMR/ESD prcoedure
The difference in pain scores between the two groups.
Pain scores will be evaluated by collecting pain scores on a Likert scale from 0 to 10, where 0 means no pain and 10 indicates maximum pain. The mean values will be compared between the two groups.
Measured: baseline, pre-procedure, immediately after the procedure
Patient satisfaction.
Patient satisfaction will be evaluated by collecting satisfaction scores on a Likert scale from 0 to 10, where 0 means completely dissatisfied and 10 indicates completely satisfied. The mean values will be compared between the two groups.
Measured: immediately after the procedure
Endoscopist satisfaction.
Endoscopist satisfaction with performing EMR/ESD using VR or standard intervention groups will be evaluated by collecting satisfaction scores on a Likert scale from 0 to 10, where 0 means completely dissatisfied and 10 indicates completely satisfied. The mean values will be compared between the two groups.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start10 May 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VRStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766162
- Sponsor's protocol ID
- 24/LO/0785
- Other IDs
- 345381
- Acronym
- VREMRESD
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Q, Zang Y, Zang W, Cai W, Li W, Guo Y, Xin C, Tu X. Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial. Clin Med (Lond). 2022 May;22(3):237-240. doi: 10.7861/clinmed.2022-0001. Epub 2022 Apr 20.
PubMed 35443967Karaveli Cakir S, Evirgen S. The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2021 May;32(5):451-457. doi: 10.5152/tjg.2021.191081.
PubMed 34231475
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Endoscopic Mucosal and Submucosal Dissection: a Patient Centred Experience "VREMRESD"
- ClinicalTrials.gov ID
- NCT06766162
- Acronym / sponsor ID
- VREMRESD / 24/LO/0785
- Conditions
- VR, Virtual Reality Pain Distraction, Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection
- Keywords
- VRESD, Virtual reality and ESD, VR and endoscopic submucosal dissection, Virtual reeality and endoscopic submucosal dissection, VRWMR, VREMRESD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Jan 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.
This study explores the feasibility of using Virtual Reality (VR) to manage pain and anxiety during Endoscopic Mucosal (EMR) and Submucosal Dissection (ESD). EMR and ESD often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. VR, by immersing patients in a calming virtual environment, has shown potential in reducing pain and anxiety in medical settings. This study aims to evaluate its application in improving pain management and reducing sedation use during EMR and ESD.
Detailed description
This study utilizes a prospective randomized controlled trial (RCT) design to evaluate the feasibility of incorporating Virtual Reality (VR) as a method for pain management during Endoscopic mucosal and (EMR) Submucosal Dissection (ESD). Participants will be randomized into two groups: one receiving VR sedation with on-demand analgesia and sedation, and the other following standard sedation protocols. The primary endpoint is to assess the feasibility of integrating VR for pain management during EMR or ESD procedures.
Eligibility criteria ensure that participants are suitable for the study. Patients must be 18 years or older, scheduled for EMR ESD, able to provide informed consent, and proficient in English. Those with contraindications for EMR, ESD, severe impairments affecting VR use, or conditions contraindicating VR are excluded. Endoscopists must be experienced in EMR and ESD, willing to participate, and fluent in English, with non-ESD practitioners or those unwilling to participate excluded.
The study aims to enroll 40 patients (20 per group) and involve five experienced endoscopists from the unit, all of whom will be consented. Secondary endpoints include the proportion of EMR and ESD procedures completed using VR, reductions in sedation and analgesia usage, differences in pain scores between the two groups, and satisfaction levels of both patients and endoscopists.
Follow-up will consist of immediate post-procedure feedback and questionnaires to gather insights on VR's impact. This trial will provide critical data on the potential for VR to enhance patient experience, optimize sedation use, and improve procedural outcomes during EMR and ESD, informing future research and clinical applications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) Arm | Experimental | Other: Virtual reality pain distractionThe VR arm will have a trial run with the VR headset in the endoscopy admission unit. The VR will then be applied at the start of the procedure. If, during the procedure, the patient requests sedation or pain medication, it will be provided. If the patient wishes to remove the VR headset, they may do so at any time. |
| Standard Arm | Active comparator | Other: Standard analgesia and sedationThe control group will follow the standard local protocol for analgesia and sedation throughout the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Able to consent.
- Fit to use virtual reality.
- Patients allocated to appropriate EMR/ ESD lists.
Key exclusion criteria (5 listed)
- Patients who are unable to consent.
- Contraindication to use VR including, epilepsy and photosensitivity.
- Planned other interventional colonoscopy (Polypectomy, Stenting).
- Visually impaired.
- Pregnancy.
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 reality pain distractionThe intervention group in this study will undergo their EMR and ESD procedure with the addition of virtual reality (VR) as a supportive tool. Participants in this group will use a VR headset during the procedure, designed to provide an immersive experience that may help manage pain and anxiety. The use of VR will be integrated alongside the standard care protocol, including routine sedation and pain management practices VR headset is from DRVR, Rescope innovation which is registered as medical device in the UK. | Other | Virtual reality (VR) Arm |
| Standard analgesia and sedationStandard local protocol for analgesia and sedation, incorporating fentanyl and midazolam. | Other | Standard Arm |
Primary outcome
To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.
Time frame: During the EMR/ESD procedure
This will evaluteed by: The completed numbers of ESD procedure with the use of the VR as an additive measure to recduce the need for analgesia and sedation.
4 secondary outcomes
The change in analgesia and sedation used while using the VR.
Time frame: During the EMR/ESD prcoedure
The difference in pain scores between the two groups.
Time frame: baseline, pre-procedure, immediately after the procedure
Patient satisfaction.
Time frame: immediately after the procedure
Endoscopist satisfaction.
Time frame: immediately after the procedure
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 11 Mar 2026.
- Background: PubMed 35443967Liu Q, Zang Y, Zang W, Cai W, Li W, Guo Y, Xin C, Tu X. Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial. Clin Med (Lond). 2022 May;22(3):237-240. doi: 10.7861/clinmed.2022-0001. Epub 2022 Apr 20.
- Background: PubMed 34231475Karaveli Cakir S, Evirgen S. The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2021 May;32(5):451-457. doi: 10.5152/tjg.2021.191081.
- Individual participant dataSharing planned: No
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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 pain distraction and Standard analgesia and sedation in people with VR and Virtual Reality Pain Distraction, run by King's College Hospital NHS 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 4 inclusion and 5 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 11 Mar 2026. 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?
To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure. (time frame: During the EMR/ESD procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766162, which also lists 2 linked publications.
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 11 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.