HealthyNCT05570214
A Study of Virtual Reality During Urological Procedures
A study testing Virtual Reality in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to see if virtual reality devices are able to distract patients during Urologic beside vasectomy procedures in the clinic and help improve patient experience and vital signs. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex.
Who cannot join
- Anyone < 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Virtual Reality on Patient Vital Signs During Urological Bedside Vasectomies
This research is being done to see if virtual reality devices are able to distract patients during Urologic beside vasectomy procedures in the clinic and help improve patient experience and vital signs.
Read the detailed description
Once participants are consented and checked in for the procedure, researchers will obtain the randomization assignment from a REDCap database with a randomization module designed by the study statistician. Participants will be randomized in a 1:1 ratio to either virtual reality or standard of care.
Researchers will collect participant vital signs (heart rate, blood pressure, and SpO2) at check in, laying down on the table, in the midst of the procedure, and after the procedure is complete. After the procedure is completed, all participants will be given two surveys about satisfaction with the experience to complete. Researchers will record any medications the participants takes the day of the procedure. Researchers will then gather demographic data from the participant's chart through Epic (age, height, weight, BMI, race, ethnicity, past medical history, and procedure information). All study data will be stored in a secure REDcap database. Researchers have teamed up with members of the anesthesia department at Mayo Clinic Florida who have performed similar studies utilizing the virtual reality headsets. The department has three virtual reality headsets and know how to operate them.
The participants who are selected to use the virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef.
- Conditions
- Healthy
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Vasectomy Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a Chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Subjects will wear a virtual reality headset during their urological bedside vasectomy. Receives: Other: Virtual Reality |
| Standard of Care Group | No intervention | Subjects will undergo standard of care urological bedside vasectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Number of beats per minute
Measured: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Change in Systolic blood pressure
Measured in millimeters of mercury (mmHg)
Measured: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Change in diastolic blood pressure
Measured in millimeters of mercury (mmHg)
Measured: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Change in oxygen saturation levels
Measured by a pulse oximeter reading reported as a percentage
Measured: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Secondary outcomes (1)
Patient satisfaction
Measured using the self-reported QoR-15 patient survey. 15-item questionnaire used to assess feelings and pain within the last 24 hours on a scale from 0 to 10; 0 indicating none of the time [poor] and 10 indicating all of the time [excellent]. Higher total scores indicate greater patient satisfaction
Measured: Post-procedure (approximately 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Lack of PI interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David D. Thiel, Mayo Clinic
- Investigators
- David Thiel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570214
- Sponsor's protocol ID
- 22-000947
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2022
- Last updated
- 22 Oct 2024
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Patient Vital Signs During Urological Bedside Vasectomies
- ClinicalTrials.gov ID
- NCT05570214
- Acronym / sponsor ID
- 22-000947
- Conditions
- Healthy
- Keywords
- Virtual Reality, Vasectomy Procedure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of PI interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Oct 2022 (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 research is being done to see if virtual reality devices are able to distract patients during Urologic beside vasectomy procedures in the clinic and help improve patient experience and vital signs.
Detailed description
Once participants are consented and checked in for the procedure, researchers will obtain the randomization assignment from a REDCap database with a randomization module designed by the study statistician. Participants will be randomized in a 1:1 ratio to either virtual reality or standard of care.
Researchers will collect participant vital signs (heart rate, blood pressure, and SpO2) at check in, laying down on the table, in the midst of the procedure, and after the procedure is complete. After the procedure is completed, all participants will be given two surveys about satisfaction with the experience to complete. Researchers will record any medications the participants takes the day of the procedure. Researchers will then gather demographic data from the participant's chart through Epic (age, height, weight, BMI, race, ethnicity, past medical history, and procedure information). All study data will be stored in a secure REDcap database. Researchers have teamed up with members of the anesthesia department at Mayo Clinic Florida who have performed similar studies utilizing the virtual reality headsets. The department has three virtual reality headsets and know how to operate them.
The participants who are selected to use the virtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual RealitySubjects will wear a virtual reality headset during their urological bedside vasectomy. |
| Standard of Care Group | No intervention | –Subjects will undergo standard of care urological bedside vasectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex.
Key exclusion criteria (1 listed)
- Anyone < 18 years of age.
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 RealityVirtual reality device will be viewing calming narrated scenarios with relaxing music of walking through a forest, along a beach, through a Chinese garden, a winter landscape or taking off in a spaceship or snorkeling through a reef | Other | Virtual Reality Group |
Primary outcome
Change in heart rate
Time frame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Number of beats per minute
Change in Systolic blood pressure
Time frame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Measured in millimeters of mercury (mmHg)
Change in diastolic blood pressure
Time frame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Measured in millimeters of mercury (mmHg)
Change in oxygen saturation levels
Time frame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Measured by a pulse oximeter reading reported as a percentage
1 secondary outcome
Patient satisfaction
Time frame: Post-procedure (approximately 1 hour)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
David Thiel, MD principal investigator
Mayo Clinic
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 Healthy, run by Mayo Clinic at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 22 Oct 2024. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in heart rate (time frame: Baseline, intra-procedure, post-procedure (approximately 1 hour)). The study lists 4 primary outcomes in all. 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 22 Oct 2024.