Virtual Reality for Urological Procedures

Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures

It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. However, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. Stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries.

The current study will examine the feasibility and pilot outcomes of Virtual Reality (VR) guided meditation therapy during cystoscopies and vasectomies. Feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the VR intervention during the procedures. The investigators will also evaluate pilot outcomes of the VR intervention on pain, anxiety, and overall satisfaction with the procedure. Results of this study will inform the development of a large-scale randomized clinical trial (RCT) to evaluate the efficacy of this intervention.

Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.

Study Overview

• Status: Completed
• Conditions: Pain; Feasibility; Satisfaction, Patient; Anxiety State
• Intervention / Treatment: Device: Virtual reality (VR) guided meditation therapy; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3P 2S8
      • Men's Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older
• can speak and read English
• have an indication for a cystoscopy or elected for a vasectomy
• are scheduled to undergo their respective procedure under local anesthesia at the Men's Health Clinic between the dates of May-November 2024.

Exclusion Criteria:

• those who are not competent to provide informed consent (e.g., due to cognitive impairment)
• those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystoscopy VR intervention; Local anesthetic and VR intervention	Device: Virtual reality (VR) guided meditation therapy; Tripp application on Meta Quest 3 VR headset
Active Comparator: Cystoscopy treatment as usual; Local anesthetic only	Other: Treatment as usual; No VR, local anesthetic only
Experimental: Vasectomy VR intervention; Local anesthetic and VR intervention	Device: Virtual reality (VR) guided meditation therapy; Tripp application on Meta Quest 3 VR headset
Active Comparator: Vasectomy treatment as usual; Local anesthetic only	Other: Treatment as usual; No VR, local anesthetic only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of individuals who consent to participation and the number of recruited participants per week	through study completion, up to 1 year
Inclusion criteria and demographic and surgery-related differences	Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants	through study completion, up to 1 year
Retention of participants in the study	Proportion of individuals who tolerate the intervention and complete the study	Immediate post-operative
Acceptability through elevate scores on the Virtual Reality Impression Scale	Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)	Immediate post-operative
Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale	Negative and positive impressions of the VR intervention (open ended/qualitative)	Immediate post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)	Brief self-report visual analogue scales (VAS) for anxiety/distress (0 thru 10, 10=worse anxiety/distress)	Pre-operative, acute post-operative (immediately following surgery)
Visual Analogue Scale pain severity	Brief self-report visual analogue scales (VAS) for acute pain (o thru 10, 10=more severe pain)	Peri-operative (mid-way through procedure)
Visual Analogue Scale anxiety severity	Brief self-report visual analogue scales (VAS) for acute anxiety (0 thru 10, 10=more severe anxiety)	Peri-operative (mid-way through procedure)
State Trait Anxiety Inventory (STAI) elevated scores	Brief self-report questionnaire with questions surrounding anxiety traits (0 thru 63, higher score=more severe anxiety)	Pre-operative, acute post-operative (immediately following surgery)
PROMIS Pain Intensity Scale total score	Brief self-report questionnaire with questions surrounding experienced pain (3 thru 15, 15=greater pain severity)	Acute post-operative (immediately following surgery)
Satisfaction With Surgery score	Item to assess overall satisfaction with surgery (0 thru 10, 10=greater satisfaction)	Acute post-operative (immediately following surgery)
Subjective assessment of time spent in VR vs. actual time in VR	Perception of time during procedure compared to actual time among those in VR	Evaluated immediate post-operative
i-Group Presence Questionnaire (IPQ) score	Brief self-report questionnaire with questions surrounding VR experience (spatial presence, involvement, experience realism), higher scores=greater presence	Acute post-operative (immediately following surgery)
Selection of VR experience	What Tripp experience that participants select (out of 5 potential programs)	Pre-operative

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Renee El-Gabalawy, PhD, University of Manitoba; Principal Investigator: Premal Patel, MD, University of Manitoba; Principal Investigator: Simone Gentile, BSc, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: feasibility; virtual reality; perioperative mental health
• Other Study ID Numbers: HS26202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No