Clinical trial NCT05570214: A Study of Virtual Reality During Urological Procedures
Official title: Impact of Virtual Reality on Patient Vital Signs During Urological Bedside Vasectomies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: Virtual Reality
Vasectomy Procedure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

- Any patient undergoing a vasectomy, transrectal prostate biopsy, cystoscopy, Doppler ultrasound, or Xiaflex.

Exclusion Criteria:

- Anyone \< 18 years of age.

Primary outcomes:
measure: Change in heart rate
timeFrame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
measure: Change in Systolic blood pressure
timeFrame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
measure: Change in diastolic blood pressure
timeFrame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
measure: Change in oxygen saturation levels
timeFrame: Baseline, intra-procedure, post-procedure (approximately 1 hour)
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Post-procedure (approximately 1 hour)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: David Thiel, MD
role: PRINCIPAL_INVESTIGATOR
References: