Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies

NCT07055178 | Recruiting

• 1 other identifier: HS26972
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vasectomy; Pain; Anxiety; Virtual Reality

Keywords

Virtual Reality; TRIPP; Vasectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Numeric Rating Scale (NRS) for Discomfort Severity

  Perioperatively (midway through procedure) and immediately following the procedure.

• Numeric Rating Scale (NRS) for Anxiety Severity

  Perioperatively (midway through procedure) and immediately following the procedure.

• PROMIS Pain Intensity Scale Total Score

  Within 10 minutes postoperatively (in the recovery room)

• State Trait Anxiety Inventory Total Score

  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)

  10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.

Study Arms (2)

Standard Vasectomy

ACTIVE COMPARATOR

Vasectomy treatment as usual, with local anesthetic, without virtual reality.

Other: Treatment as usual

Virtual Reality Vasectomy

EXPERIMENTAL

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

Interventions

Virtual reality (VR) guided meditation therapy DEVICE

Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.

Virtual Reality Vasectomy

Treatment as usual OTHER

Participants undergo a standard vasectomy.

Standard Vasectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Manitoba Men's Health Clinic

Winnipeg, Manitoba, R3P 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renée El-Gabalawy, MA, PhD, C.Psych.

CONTACT

204-787-4083; renee.el-gabalawy@umanitoba.ca

Ahmed M Zalam, B.Sc.

CONTACT

204-880-6564; zalama@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 8, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)