Patient SatisfactionNCT06636292
VRDD in Upper Gastrointestinal Endoscopy
A study testing Virtual Reality Distraction and Disassociation (VRDD) Stage 1 and Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2 in people with Patient Satisfaction and Patient Acceptance of Health Care, run by South Tyneside and Sunderland NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The demand for gastrointestinal (GI) endoscopy is rising year by year and improving the patient's experience of having the procedure has become an important aim. A lot of work has been done in recent years on how to improve a patient's experience during GI endoscopy such as improving endoscopy and communication… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Patient Acceptance of Health Care
- What is being tested?
- Virtual Reality Distraction and Disassociation (VRDD) Stage 1 and Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2024to 10 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referred with a clinical need for upper GI endoscopy (either transnasal or per oral route) on an elective basis.
Who cannot join
- Planned therapeutic procedures (including but not limited to polypectomy, balloon dilatation, stenting).
- Uncorrected visual or auditory impairments or adaptions (e.g. spectacles) that make wearing the VR equipment difficult.
- Cognitive impairment or learning disabilities.
- Epilepsy.
- Balance disorders.
- Referred for urgent or emergency GI endoscopy.
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- Withdrawal criteria:
- Patients who withdraw consent from study participation.
- Patients who withdraw consent for having the endoscopy procedure.
- Patients who request to remove the VRDD equipment during Stages 1 or 2 of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Tyneside District Hospital
South Shields, Tyne and Wear, NE34 0PL
About this study
Official title: Using Virtual Reality Distraction and Disassociation (VRDD) in Adult Gastrointestinal Endoscopy
The demand for gastrointestinal (GI) endoscopy is rising year by year and improving the patient's experience of having the procedure has become an important aim. A lot of work has been done in recent years on how to improve a patient's experience during GI endoscopy such as improving endoscopy and communication skills. Due to the increasing popularity of Virtual Reality (VR) in the gaming world, VR equipment have been used in children as a safe and effective distraction method during GI endoscopy, removing the need for them to have general anaesthesia for their procedure. This has been thought of as an option for the adult patients which would also save them from requiring sedation for their endoscopy procedure.
This is a pilot feasibility study (small scale preliminary study) carried out at a single hospital site with a dedicated GI endoscopy service. We intend to find out whether the VR headset that is used is tolerated and accepted by adult patients during their endoscopy procedure. This has been shown to be a cheaper option compared to giving sedation drugs or general anaesthesia as well. If adult patients can accept this option, we are hoping to investigate in future larger studies whether they could potentially use this as a distraction method to help improve their experience of undergoing GI endoscopy. Any adult patient who is having an upper GI endoscopy could be potentially eligible. Their endoscopy procedure forms part of their clinical care whereas the research component involves them wearing the VR headset before and/or during their procedure. Their experience of undergoing upper GI endoscopy and wearing the VR headset will be measured using a series of questionnaires.
Read the detailed description
Study design:
This is a small scale preliminary study (pilot feasibility study) which is split into 2 stages. In the first stage, it will investigate if the VRDD equipment is acceptable for an adult patient to use prior to any upper GI endoscopy, including sedated and unsedated procedures. In the second stage, it will investigate whether the VRDD equipment is acceptable specifically for adult patients who have unsedated transnasal endoscopy (TNE). This study will be carried out by the research team who are based at one National Health Service (NHS) hospital i.e. South Tyneside District Hospital in the United Kingdom. The study is funded by EvoEndo, Inc which is based in Colorado, USA (provision of VR equipment). The investigators aim to recruit approximately 30 participants to the study, all of whom will have been referred for an upper GI endoscopy procedure for any clinical reason.
Once a patient has expressed their interest, they will be provided with a participant information sheet to read through. A research team member will be available to answer any queries. Patients who are keen to participate in the study will be asked to sign a consent form for them to be officially recruited into the study. This can be done a few days prior or on the day of their endoscopy procedure. It will be made clear to them that their endoscopy procedure will go ahead regardless of their participation in research because the procedure itself is part of standard clinical care and not research. They will need to sign a separate NHS consent form specifically for the upper GI endoscopy procedure which will be handled by the endoscopy team.
The VR equipment comprises of a headset which the participants will wear right before their procedure. It can play virtual reality images or videos from a mobile phone attached to the front of the headset. The VR content has been provided by the funding body (EvoEndo, Inc) which includes classic television programmes, sports programmes, movies, documentaries and children's entertainment.
Stage 1:
In Stage 1, participants will put on the VR headset before their endoscopy for approximately 10 minutes under supervision of a research team member. Once time is up, the VR headset will be removed and Stage 1 is complete. Participants will be provided with a few questionnaires that are relevant to this stage to complete in their own time.
They will be monitored for approximately another 10 minutes for any adverse effects before they proceed to their endoscopy procedure.
Stage 2:
This only involves patients who are having unsedated transnasal endoscopy. Patients who are having a gastroscopy will not progress to this stage.
For patients who choose to have transnasal endoscopy without sedation, the research team member will ask if they would like to proceed to Stage 2 of the study. This involves wearing the VR headset during their endoscopy. If they agree, it will be reattached onto them after all routine safety checks have been completed pre-endoscopy. The VR headset will remain on them for the duration of their endoscopy, unless they withdraw consent for using VRDD. After the endoscopy is completed, the VR headset will be removed for the participant to take home with them. They will be asked to remain in the endoscopy unit for approximately 10 minutes to allow any VRDD side effects to resolve before they leave. However, if they choose to not proceed onto Stage 2, this indicates the end of their participation in the study. The endoscopy procedure will still go ahead because it is part of standard clinical care.
Patients who have sedation for endoscopy will not be eligible to participate in Stage 2 of the study.
Participants can withdraw consent at any point. If they decide to withdraw study participation before the endoscopy, they would be asked to contact the research team about it. If they decide to withdraw study participation during their endoscopy, they would be advised to inform the endoscopy nurses who will inform the research team. A research team member will then remove the VR headset. Endoscopy will continue in both these scenarios because it is part of standard care. If participants withdraw consent for endoscopy at any point, they automatically become ineligible for the study.
Participants will not be able to remove their VR headset without assistance. If they confirm that they want to remove their headset, they can notify the endoscopy nurses who will ask a research team member who is outside the endoscopy room to come in to remove it. This would be considered a withdrawal of consent for ongoing study participation.
Data collection:
All participants from both stages will be asked to complete the VRDD questionnaire which assesses their experience of using the VR headset. In addition, they will be asked to complete the Newcastle ENDOPREM™ (assess patient experience of having upper GI endoscopy) and the modified Group Health Association of America-9 (mGHAA-9) survey. Participants can complete the questionnaires either on the day after they have had their endoscopy or at home. Completed questionnaires can be posted back to the research department in pre-paid envelopes which are marked confidential. All participants are strongly encouraged to do this within 3-4 days of their endoscopy and the latest within 7 days to allow an accurate recollection and reflection of their experiences. They may be contacted via telephone by a research team member on day 4, day 8 and day 10 after the endoscopy as a reminder if it is necessary to do so. The research team will be responsible for ensuring that all questionnaires have been received from the participants.
The end of study is defined as the date of the last visit of the last participant and by completion of data collection from the questionnaires.
It is anticipated that the investigators will need approximately 2-3 months to meet the recruitment target. Data collected from the questionnaire responses will be analysed and summarised by the research team. No follow-up research appointments are required from the study participants.
- Being tested
- Virtual Reality Distraction and Disassociation (VRDD) Stage 1, Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2
- Keywords
- virtual reality, upper gastrointestinal endoscopy, transnasal endoscopy
- Medical subject headings
- Patient Satisfaction, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Distraction and Disassociation (VRDD) Stage 1Device
Participants wear a VR headset which plays VR content/material pre- endoscopy only.
Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2Device
Participants wear a VR headset which plays VR content/material pre- endoscopy and during endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Patients having sedated TNE or any oesophagogastroduodenoscopy (OGD) | Active comparator | Patients who are only recruited to Stage 1 of study to experience VRDD pre-endoscopy. Receives: Device: Virtual Reality Distraction and Disassociation (VRDD) Stage 1 |
| Patients having unsedated TNE | Active comparator | Patients who are recruited to both Stages 1 and 2 of study to experience VRDD pre-endoscopy and during endoscopy. Receives: Device: Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and tolerability of VRDD in adult patients using VRDD questionnaire
The acceptability and tolerability of using VRDD in all adult patients referred for upper GI endoscopy, measured on Likert scale via VRDD questionnaire
Measured: 2-3 months
Secondary outcomes (2)
Acceptability of VRDD in unsedated TNE using VRDD questionnaire
The acceptability of using VRDD in adult patients who undergo unsedated TNE, measured on Likert scale via VRDD questionnaire
Measured: 2-3 months
Patient experience of using VRDD while having unsedated TNE using Newcastle ENDOPREM™ and mGHAA-9 questionnaires
The patient experience of undergoing unsedated TNE while using VRDD, measured on Likert scale via Newcastle ENDOPREM™ and mGHAA-9 questionnaires
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start23 Feb 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- EvoEndo, Inc.
- Responsible party
- Sponsor
- Investigators
- Phey Shen Lee, Study chair, South Tyneside and Sunderland NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636292
- Sponsor's protocol ID
- 323884
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2024
- Last updated
- 30 Jul 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality Distraction and Disassociation (VRDD) in Adult Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06636292
- Acronym / sponsor ID
- 323884
- Keywords
- virtual reality, upper gastrointestinal endoscopy, transnasal endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation TrustUniversity, hospital or other
- Collaborators
- EvoEndo, Inc.
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 10 Oct 2024 (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.
The demand for gastrointestinal (GI) endoscopy is rising year by year and improving the patient's experience of having the procedure has become an important aim. A lot of work has been done in recent years on how to improve a patient's experience during GI endoscopy such as improving endoscopy and communication skills. Due to the increasing popularity of Virtual Reality (VR) in the gaming world, VR equipment have been used in children as a safe and effective distraction method during GI endoscopy, removing the need for them to have general anaesthesia for their procedure. This has been thought of as an option for the adult patients which would also save them from requiring sedation for their endoscopy procedure.
This is a pilot feasibility study (small scale preliminary study) carried out at a single hospital site with a dedicated GI endoscopy service. We intend to find out whether the VR headset that is used is tolerated and accepted by adult patients during their endoscopy procedure. This has been shown to be a cheaper option compared to giving sedation drugs or general anaesthesia as well. If adult patients can accept this option, we are hoping to investigate in future larger studies whether they could potentially use this as a distraction method to help improve their experience of undergoing GI endoscopy. Any adult patient who is having an upper GI endoscopy could be potentially eligible. Their endoscopy procedure forms part of their clinical care whereas the research component involves them wearing the VR headset before and/or during their procedure. Their experience of undergoing upper GI endoscopy and wearing the VR headset will be measured using a series of questionnaires.
Detailed description
Study design:
This is a small scale preliminary study (pilot feasibility study) which is split into 2 stages. In the first stage, it will investigate if the VRDD equipment is acceptable for an adult patient to use prior to any upper GI endoscopy, including sedated and unsedated procedures. In the second stage, it will investigate whether the VRDD equipment is acceptable specifically for adult patients who have unsedated transnasal endoscopy (TNE). This study will be carried out by the research team who are based at one National Health Service (NHS) hospital i.e. South Tyneside District Hospital in the United Kingdom. The study is funded by EvoEndo, Inc which is based in Colorado, USA (provision of VR equipment). The investigators aim to recruit approximately 30 participants to the study, all of whom will have been referred for an upper GI endoscopy procedure for any clinical reason.
Once a patient has expressed their interest, they will be provided with a participant information sheet to read through. A research team member will be available to answer any queries. Patients who are keen to participate in the study will be asked to sign a consent form for them to be officially recruited into the study. This can be done a few days prior or on the day of their endoscopy procedure. It will be made clear to them that their endoscopy procedure will go ahead regardless of their participation in research because the procedure itself is part of standard clinical care and not research. They will need to sign a separate NHS consent form specifically for the upper GI endoscopy procedure which will be handled by the endoscopy team.
The VR equipment comprises of a headset which the participants will wear right before their procedure. It can play virtual reality images or videos from a mobile phone attached to the front of the headset. The VR content has been provided by the funding body (EvoEndo, Inc) which includes classic television programmes, sports programmes, movies, documentaries and children's entertainment.
Stage 1:
In Stage 1, participants will put on the VR headset before their endoscopy for approximately 10 minutes under supervision of a research team member. Once time is up, the VR headset will be removed and Stage 1 is complete. Participants will be provided with a few questionnaires that are relevant to this stage to complete in their own time.
They will be monitored for approximately another 10 minutes for any adverse effects before they proceed to their endoscopy procedure.
Stage 2:
This only involves patients who are having unsedated transnasal endoscopy. Patients who are having a gastroscopy will not progress to this stage.
For patients who choose to have transnasal endoscopy without sedation, the research team member will ask if they would like to proceed to Stage 2 of the study. This involves wearing the VR headset during their endoscopy. If they agree, it will be reattached onto them after all routine safety checks have been completed pre-endoscopy. The VR headset will remain on them for the duration of their endoscopy, unless they withdraw consent for using VRDD. After the endoscopy is completed, the VR headset will be removed for the participant to take home with them. They will be asked to remain in the endoscopy unit for approximately 10 minutes to allow any VRDD side effects to resolve before they leave. However, if they choose to not proceed onto Stage 2, this indicates the end of their participation in the study. The endoscopy procedure will still go ahead because it is part of standard clinical care.
Patients who have sedation for endoscopy will not be eligible to participate in Stage 2 of the study.
Participants can withdraw consent at any point. If they decide to withdraw study participation before the endoscopy, they would be asked to contact the research team about it. If they decide to withdraw study participation during their endoscopy, they would be advised to inform the endoscopy nurses who will inform the research team. A research team member will then remove the VR headset. Endoscopy will continue in both these scenarios because it is part of standard care. If participants withdraw consent for endoscopy at any point, they automatically become ineligible for the study.
Participants will not be able to remove their VR headset without assistance. If they confirm that they want to remove their headset, they can notify the endoscopy nurses who will ask a research team member who is outside the endoscopy room to come in to remove it. This would be considered a withdrawal of consent for ongoing study participation.
Data collection:
All participants from both stages will be asked to complete the VRDD questionnaire which assesses their experience of using the VR headset. In addition, they will be asked to complete the Newcastle ENDOPREM™ (assess patient experience of having upper GI endoscopy) and the modified Group Health Association of America-9 (mGHAA-9) survey. Participants can complete the questionnaires either on the day after they have had their endoscopy or at home. Completed questionnaires can be posted back to the research department in pre-paid envelopes which are marked confidential. All participants are strongly encouraged to do this within 3-4 days of their endoscopy and the latest within 7 days to allow an accurate recollection and reflection of their experiences. They may be contacted via telephone by a research team member on day 4, day 8 and day 10 after the endoscopy as a reminder if it is necessary to do so. The research team will be responsible for ensuring that all questionnaires have been received from the participants.
The end of study is defined as the date of the last visit of the last participant and by completion of data collection from the questionnaires.
It is anticipated that the investigators will need approximately 2-3 months to meet the recruitment target. Data collected from the questionnaire responses will be analysed and summarised by the research team. No follow-up research appointments are required from the study participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients having sedated TNE or any oesophagogastroduodenoscopy (OGD) | Active comparator | Device: Virtual Reality Distraction and Disassociation (VRDD) Stage 1Patients who are only recruited to Stage 1 of study to experience VRDD pre-endoscopy. |
| Patients having unsedated TNE | Active comparator | Device: Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2Patients who are recruited to both Stages 1 and 2 of study to experience VRDD pre-endoscopy and during endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred with a clinical need for upper GI endoscopy (either transnasal or per oral route) on an elective basis.
Key exclusion criteria (10 listed)
- Planned therapeutic procedures (including but not limited to polypectomy, balloon dilatation, stenting).
- Uncorrected visual or auditory impairments or adaptions (e.g. spectacles) that make wearing the VR equipment difficult.
- Cognitive impairment or learning disabilities.
- Epilepsy.
- Balance disorders.
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 Distraction and Disassociation (VRDD) Stage 1Participants wear a VR headset which plays VR content/material pre- endoscopy only. | Device | Patients having sedated TNE or any oesophagogastroduodenoscopy (OGD) |
| Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2Participants wear a VR headset which plays VR content/material pre- endoscopy and during endoscopy. | Device | Patients having unsedated TNE |
Primary outcome
Acceptability and tolerability of VRDD in adult patients using VRDD questionnaire
Time frame: 2-3 months
The acceptability and tolerability of using VRDD in all adult patients referred for upper GI endoscopy, measured on Likert scale via VRDD questionnaire
2 secondary outcomes
Acceptability of VRDD in unsedated TNE using VRDD questionnaire
Time frame: 2-3 months
Patient experience of using VRDD while having unsedated TNE using Newcastle ENDOPREM™ and mGHAA-9 questionnaires
Time frame: 2-3 months
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 30 Jul 2025.
- 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.
Phey Shen Lee study chair
South Tyneside and Sunderland NHS Foundation Trust
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 Distraction and Disassociation (VRDD) Stage 1 and Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2 in people with Patient Satisfaction and Patient Acceptance of Health Care, run by South Tyneside and Sunderland 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 10 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 30 Jul 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?
Acceptability and tolerability of VRDD in adult patients using VRDD questionnaire (time frame: 2-3 months). 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 30 Jul 2025.