Patient SatisfactionVIPNCT04862598
Virtual Reality to Improve Satisfaction in Hysteroscopy Patients
A study testing Oculus Virtual Reality in people with Patient Satisfaction and Virtual Reality, run by University of British Columbia at 1 site in Canada.
Trial summary
This study aims to investigate whether viewing an immersive virtual reality (VR) image through a VR headset during elective hysteroscopy under Registered Nurse (RN) led sedation with fentanyl and midazolam plus local anesthesia (monitored anesthetic care) will improve patient satisfaction with their anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Virtual Reality, Hysteroscopy
- What is being tested?
- Oculus Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2021to 13 Feb 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 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indications for hysteroscopy under RN-provided sedation
Who cannot join
- Inability to provide informed consent to participate in the study (e.g. significant language barrier)
- Severe cognitive impairment
- Chronic benzodiazepine use
- Chronic opioid use
- Presence or history of psychotic psychiatric disorders
- Presence or history of seizure disorders
- Visual acuity <1 with correction
- Hearing impairment requiring correction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality to Improve Satisfaction in Patients Undergoing Hysteroscopy: A Single-centre Randomized Controlled Trial
This study aims to investigate whether viewing an immersive virtual reality (VR) image through a VR headset during elective hysteroscopy under Registered Nurse (RN) led sedation with fentanyl and midazolam plus local anesthesia (monitored anesthetic care) will improve patient satisfaction with their anesthesia. Patients will be randomized to either receive usual care or usual care plus VR. Satisfaction will be measured by asking patients to complete a post-procedure survey consisting of 11 questions.
Read the detailed description
Purpose: To determine whether viewing an immersive VR image (viewed over an Oculus Quest VR headset) during hysteroscopy can improve patient satisfaction with their anesthesia (sedation plus local anesthesia). The VR image used in the study is Cosmic Flow: A Relaxing VR experience, which is freely available from Oculus. The patient will also wear headphones during the study which will play relaxing meditation music.
Hypothesis: The use of immersive VR during elective hysteroscopy under sedation will improve patient satisfaction with their anesthesia by at least 20%, measured using the Iowa Satisfaction with Anesthesia Scale.
Justification: Ambulatory hysteroscopy is conducted under general anesthesia or in the established Procedural Sedation Program. The latter involves Registered Nurse (RN) led sedation, consisting of the administration of sedation (midazolam) and analgesia (fentanyl) to reduce discomfort and anxiety. However, these medications have unwanted side-effects such as over-sedation and nausea, which can delay discharge and reduce patient satisfaction with their procedure. To minimize these complications, non-pharmacological therapy is of interest, as it aims to reduce the need and dosage of these medications. Virtual reality is one such non-pharmacological intervention which has been trialled in several settings, and has been shown to have beneficial effects on pain and anxiety during procedures such as wound dressing changes, upper GI endoscopies and dental procedures. Virtual reality use in the healthcare setting is currently in an early phase of research, and more study is needed on effects of VR on precise outcomes such as patient satisfaction, which is an important marker for quality in healthcare.
Objectives: The objective is to study patient reported satisfaction with their anesthesia (sedation plus local anesthesia) when they receive standard care to when they receive standard care plus viewing an immersive VR image during their hysteroscopy procedure.
Research Design: This is a randomized controlled trial involving data collection before, during and after the hysteroscopy procedure.
Statistical Analysis: The primary outcome in change in patient satisfaction scores will be compared using paired t-test. For secondary outcomes, all continuous data will be compared using t-test or Mann-Whitney U test as appropriate. Incidence and proportion outcomes will be analyzed using Fisher exact test.
- Conditions
- Patient Satisfaction, Virtual Reality, Hysteroscopy
- Being tested
- Oculus Virtual Reality
- Keywords
- Virtual Reality, Hysteroscopy, Iowa Satisfaction Scale, Sedation
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Virtual RealityDevice
The patient will receive standard care, augmented with virtual reality. Their post-operative satisfaction score will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The patient will be positioned on the operating table and have routine monitoring attached (ECG, blood pressure, O2 saturations, end tidal carbon dioxide monitoring (ETCO2). A surgical safety time out will be performed. The patient will receive routine operative and nursing care. The study team member will record highest and lowest heart rate and blood pressure as well as lowest O2 saturation and the total intra-operative dose of fentanyl and midazolam administered to the patient. At the end of the procedure, the patient is assisted into a wheelchair and will return to the recovery area. After 15 minutes of recovery, a member of the study team will give them the post-operative questionnaires which will consist of answering how anxious they felt during the procedure and the 11 question Iowa Satisfaction with Anesthesia scale (ISAS). The patient will then be free to leave once they have met the standard discharge criteria. |
| VR Group | Experimental | The patient wears the VR headset after being positioned on the table and the surgical time out has been completed. The VR scene and accompanying music will continue until the end of the procedure or until the patient wishes for it to be removed. The patient will receive standard operative and nursing care. The study team member will record the intra-operative vitals as detailed in the control group procedure. At the end of the procedure, the patient will be moved to recovery and will receive standard care. At 15 minutes, they will be provided with the anxiety questionnaire and the ISAS. Additional questions will be asked; their level of VR immersion and if they would like to receive the VR technology again if they were to undergo another procedure in the future. They will then be free to leave once they have met the standard discharge criteria. Receives: Device: Oculus Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Change in post-procedure patient satisfaction score (Iowa Satisfaction Scale) of at least 0.6 between the Virtual Reality group and the control group. High scores are better than low scores which are worse. Scores range from -3 (completely unsatisfied) to 3 (completely satisfied)
Measured: 15 minutes post-operatively
Secondary outcomes (8)
Patient anxiety scores before and after the procedure
10-point Likert Scale
Measured: 30 minutes before operation (one anxiety score). 15 minutes after operation (one anxiety score). On a 10 point Likert anxiety scale (0-10) high scores are more anxious and low scores are less anxious.
Total Fentanyl dose
Total IV Fentanyl dose in mcgs during the procedure
Measured: 45 minutes throughout the operation
Total Midazolam dose
Total IV Midazolam dose in mgs during the procedure
Measured: 45 minutes throughout the operation
Occurrence of intraoperative hemodynamic changes
Increase/decrease of 30 percent of SBP or HR compared to baseline
Measured: 45 minutes throughout the operation
Incidence of desaturation
Pulse oxygen saturation <90 percent
Measured: 45 minutes throughout the operation
Incidence of early termination of VR experience
Noting whether the patient decides to terminate the VR experience before the end of their procedure.
Measured: Noted during the procedure
Proportion of patients wishing to use the technology again
Yes/No response
Measured: Noted 15 minutes after the operation
Immersion perception score of the VR system
10 point Likert scale. On a 10 point Likert immersion scale (0-10) high scores are more immersed and low scores are less immersed.
Measured: 15 minutes after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start24 Mar 2021
- Primary completion1 Jun 2022
- Study completion13 Feb 2025
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.
- More trials run by University of British ColumbiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862598
- Sponsor's protocol ID
- H20-03663
- Acronym
- VIP
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Improve Satisfaction in Patients Undergoing Hysteroscopy: A Single-centre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04862598
- Acronym / sponsor ID
- VIP / H20-03663
- Conditions
- Patient Satisfaction, Virtual Reality, Hysteroscopy
- Keywords
- Virtual Reality, Hysteroscopy, Iowa Satisfaction Scale, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 28 Apr 2021 (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 aims to investigate whether viewing an immersive virtual reality (VR) image through a VR headset during elective hysteroscopy under Registered Nurse (RN) led sedation with fentanyl and midazolam plus local anesthesia (monitored anesthetic care) will improve patient satisfaction with their anesthesia. Patients will be randomized to either receive usual care or usual care plus VR. Satisfaction will be measured by asking patients to complete a post-procedure survey consisting of 11 questions.
Detailed description
Purpose: To determine whether viewing an immersive VR image (viewed over an Oculus Quest VR headset) during hysteroscopy can improve patient satisfaction with their anesthesia (sedation plus local anesthesia). The VR image used in the study is Cosmic Flow: A Relaxing VR experience, which is freely available from Oculus. The patient will also wear headphones during the study which will play relaxing meditation music.
Hypothesis: The use of immersive VR during elective hysteroscopy under sedation will improve patient satisfaction with their anesthesia by at least 20%, measured using the Iowa Satisfaction with Anesthesia Scale.
Justification: Ambulatory hysteroscopy is conducted under general anesthesia or in the established Procedural Sedation Program. The latter involves Registered Nurse (RN) led sedation, consisting of the administration of sedation (midazolam) and analgesia (fentanyl) to reduce discomfort and anxiety. However, these medications have unwanted side-effects such as over-sedation and nausea, which can delay discharge and reduce patient satisfaction with their procedure. To minimize these complications, non-pharmacological therapy is of interest, as it aims to reduce the need and dosage of these medications. Virtual reality is one such non-pharmacological intervention which has been trialled in several settings, and has been shown to have beneficial effects on pain and anxiety during procedures such as wound dressing changes, upper GI endoscopies and dental procedures. Virtual reality use in the healthcare setting is currently in an early phase of research, and more study is needed on effects of VR on precise outcomes such as patient satisfaction, which is an important marker for quality in healthcare.
Objectives: The objective is to study patient reported satisfaction with their anesthesia (sedation plus local anesthesia) when they receive standard care to when they receive standard care plus viewing an immersive VR image during their hysteroscopy procedure.
Research Design: This is a randomized controlled trial involving data collection before, during and after the hysteroscopy procedure.
Statistical Analysis: The primary outcome in change in patient satisfaction scores will be compared using paired t-test. For secondary outcomes, all continuous data will be compared using t-test or Mann-Whitney U test as appropriate. Incidence and proportion outcomes will be analyzed using Fisher exact test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The patient will be positioned on the operating table and have routine monitoring attached (ECG, blood pressure, O2 saturations, end tidal carbon dioxide monitoring (ETCO2). A surgical safety time out will be performed. The patient will receive routine operative and nursing care. The study team member will record highest and lowest heart rate and blood pressure as well as lowest O2 saturation and the total intra-operative dose of fentanyl and midazolam administered to the patient. At the end of the procedure, the patient is assisted into a wheelchair and will return to the recovery area. After 15 minutes of recovery, a member of the study team will give them the post-operative questionnaires which will consist of answering how anxious they felt during the procedure and the 11 question Iowa Satisfaction with Anesthesia scale (ISAS). The patient will then be free to leave once they have met the standard discharge criteria. |
| VR Group | Experimental | Device: Oculus Virtual RealityThe patient wears the VR headset after being positioned on the table and the surgical time out has been completed. The VR scene and accompanying music will continue until the end of the procedure or until the patient wishes for it to be removed. The patient will receive standard operative and nursing care. The study team member will record the intra-operative vitals as detailed in the control group procedure. At the end of the procedure, the patient will be moved to recovery and will receive standard care. At 15 minutes, they will be provided with the anxiety questionnaire and the ISAS. Additional questions will be asked; their level of VR immersion and if they would like to receive the VR technology again if they were to undergo another procedure in the future. They will then be free to leave once they have met the standard discharge criteria. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indications for hysteroscopy under RN-provided sedation
Key exclusion criteria (8 listed)
- Inability to provide informed consent to participate in the study (e.g. significant language barrier)
- Severe cognitive impairment
- Chronic benzodiazepine use
- Chronic opioid use
- Presence or history of psychotic psychiatric 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 |
|---|---|---|
| Oculus Virtual RealityThe patient will receive standard care, augmented with virtual reality. Their post-operative satisfaction score will be recorded. | Device | VR Group |
Primary outcome
Patient Satisfaction
Time frame: 15 minutes post-operatively
Change in post-procedure patient satisfaction score (Iowa Satisfaction Scale) of at least 0.6 between the Virtual Reality group and the control group. High scores are better than low scores which are worse. Scores range from -3 (completely unsatisfied) to 3 (completely satisfied)
8 secondary outcomes
Patient anxiety scores before and after the procedure
Time frame: 30 minutes before operation (one anxiety score). 15 minutes after operation (one anxiety score). On a 10 point Likert anxiety scale (0-10) high scores are more anxious and low scores are less anxious.
Total Fentanyl dose
Time frame: 45 minutes throughout the operation
Total Midazolam dose
Time frame: 45 minutes throughout the operation
Occurrence of intraoperative hemodynamic changes
Time frame: 45 minutes throughout the operation
Incidence of desaturation
Time frame: 45 minutes throughout the operation
Incidence of early termination of VR experience
Time frame: Noted during the procedure
Proportion of patients wishing to use the technology again
Time frame: Noted 15 minutes after the operation
Immersion perception score of the VR system
Time frame: 15 minutes after the operation.
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 6 Oct 2026.
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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.
Anton Chau, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Virtual Reality in people with Patient Satisfaction and Virtual Reality, run by University of British Columbia at 1 site in Canada.
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 8 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 6 Oct 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 Canada. 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?
Patient Satisfaction (time frame: 15 minutes post-operatively). 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 6 Oct 2026.