A Study of Virtual Reality During Urological Procedures

Healthy Clinical Trial

Official title:

Impact of Virtual Reality on Patient Vital Signs During Urological Bedside Vasectomies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570214
• Other study ID #: 22-000947
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Anyone < 18 years of age.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Virtual Reality
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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate	Number of beats per minute	Baseline, intra-procedure, post-procedure (approximately 1 hour)
Primary	Change in Systolic blood pressure	Measured in millimeters of mercury (mmHg)	Baseline, intra-procedure, post-procedure (approximately 1 hour)
Primary	Change in diastolic blood pressure	Measured in millimeters of mercury (mmHg)	Baseline, intra-procedure, post-procedure (approximately 1 hour)
Primary	Change in oxygen saturation levels	Measured by a pulse oximeter reading reported as a percentage	Baseline, intra-procedure, post-procedure (approximately 1 hour)
Secondary	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	Post-procedure (approximately 1 hour)

External Links

•   Mayo Clinic Clinical Trials