Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies

A Perioperative Virtual Reality Intervention for Pain and Anxiety Management During Vasectomies: A Randomized Controlled Trial

The goal of this clinical trial is to learn if a virtual reality (VR) program (TRIPP) can reduce pain, anxiety, and distress in adult men (aged 18+) undergoing a vasectomy under local anesthesia. The main questions it aims to answer are:

• Does using VR during a vasectomy lower patients' pain during the procedure compared to standard care?
• Does VR reduce anxiety and distress compared to standard care?
• Are patients more satisfied with their experience when using VR compared to standard care?

Researchers will compare two groups:

• VR group: Patients will use a VR headset with a guided meditation program (TRIPP) during their vasectomy.
• Control group: Patients will receive standard care (no VR).

Participants will:

• Be randomly assigned to either the VR group or control group.
• Complete brief questionnaires before, during, and after the procedure (about 15-20 minutes each time).
• (VR group only) Use a VR headset during the procedure and provide optional feedback about the experience.

Why is this important? Vasectomies are typically done with local anesthesia (pain relief), but many patients still feel anxiety or discomfort. VR may help distract and relax patients, improving their experience. This study will help health professionals understand if VR could be a useful option for future patients.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Virtual Reality; Vasectomy
• Intervention / Treatment: Other: Treatment as usual; Device: Virtual reality (VR) guided meditation therapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renée El-Gabalawy, MA, PhD, C.Psych.; Phone Number: 204-787-4083; Email: renee.el-gabalawy@umanitoba.ca
• Study Contact Backup: Name: Ahmed M Zalam, B.Sc.; Phone Number: 204-880-6564; Email: zalama@myumanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3P 2S8
      • Recruiting
      • Manitoba Men's Health Clinic
      • Contact: Ahmed M Zalam, B.Sc.; Phone Number: 204-880-6564; Email: zalama@myumanitoba.ca
      • Contact: Premal Patel, MD, FRCSC; Phone Number: 204-221-4476; Email: ppatel5@hsc.mb.ca
      • Principal Investigator: Premal Patel, MD, FRCSC
      • Principal Investigator: Ahmed M Zalam, B.Sc.

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 elected for a vasectomy.
• Are scheduled to undergo their vasectomy under local anesthesia at the Men's Health Clinic

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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Vasectomy; Vasectomy treatment as usual, with local anesthetic, without virtual reality.	Other: Treatment as usual; Participants undergo a standard vasectomy.
Experimental: Virtual Reality Vasectomy; This group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic.	Device: Virtual reality (VR) guided meditation therapy; Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) for Pain Severity	During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute pain, this is on a scale of 0-10; 10 = most severe pain.	Perioperatively (midway through procedure) and immediately following the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) for Discomfort Severity	During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute discomfort, this is on a scale of 0-10; 10 = most severe pain.	Perioperatively (midway through procedure) and immediately following the procedure.
Numeric Rating Scale (NRS) for Anxiety Severity	During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute anxiety, this is on a scale of 0-10; 10 = most severe pain.	Perioperatively (midway through procedure) and immediately following the procedure.
PROMIS Pain Intensity Scale Total Score	Immediately following the procedure, patients will be asked to respond to a short verbal Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity questionnaire with questions surrounding experienced pain (scored 3 - 15 ; 15 = greatest pain severity).	Within 10 minutes postoperatively (in the recovery room)
State Trait Anxiety Inventory Total Score	Brief self-report questionnaire with questions surrounding anxiety traits (scale 0-63 ; 63 = most severe anxiety)	10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.
National Comprehensive Cancer Network (NCCN) Anxiety Thermometer Score (adapted from Distress Thermometer)	Brief self-report visual analogue scale (VAS) for anxiety. Scored from 0-10 ; 10 = extreme anxiety.	10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.
Satisfaction with Surgery	Brief self-report item to assess overall satisfaction with their procedure. Scaled from 0-10 ; 10 = greatest satisfaction.	Within 10 minutes postoperatively (in the recovery room).
iGroup Presence Questionnaire (IPQ) Score	Brief self-report questionnaire with several questions surrounding VR experience (spatial presence, involvement, and experience realism). Each question is scored independently on a 7-point Likert scale (from -3 to +3).	Within 10 minutes postoperatively (in the recovery room).
Virtual Reality Impressions Scale	Brief self-report questionnaire with several questions surrounding the virtual reality program experience (spatial presence, involvement, and experience realism). Each question is scored independently on a 0 - 10 scale ; 0 = complete disagreement, 10 = complete agreement.	Within 10 minutes postoperatively (in the recovery room).

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Renée El-Gabalawy, MA, PhD, C. Psych, University of Manitoba; Principal Investigator: Premal Patel, MD, FRCSC, Manitoba Men's Health Clinic; Principal Investigator: Ahmed M Zalam, B.Sc., University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: July 3, 2025
• First Posted (Actual): July 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; Vasectomy; TRIPP
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Therapeutics
• Other Study ID Numbers: HS26972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data and information from the study will not be sent outside of the University of Manitoba. Records containing health related information will be treated as confidential in accordance with Personal Health Information Act of Manitoba (PHIA). Information gathered in this research study may be published or presented in public forums, however names and other identifying personal information will not be revealed. Data will be coded and names will not be released.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No