Recruiting

TRIPP

Sponsor:

University of Manitoba

Code:

NCT07055178

Conditions

Vasectomy

Pain

Anxiety

Virtual Reality

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Virtual reality (VR) guided meditation therapy

Treatment as usual

Study Details

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

Study ID

NCT07055178

Start date

Jul 2, 2025

Status verified date

Jul, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Vasectomy

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

experimental: Virtual Reality Vasectomy

This group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic.

Interventions

Virtual reality (VR) guided meditation therapy

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

Treatment as usual

Participants undergo a standard vasectomy.

Primary outcome measure

  • Numeric Rating Scale (NRS) for Pain Severity [ Time Frame: Perioperatively (midway through procedure) and immediately following the procedure. ]

Central Contacts and Locations

Central contacts

Renée El-Gabalawy, MA, PhD, C.Psych.

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

Locations

Manitoba Men's Health Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3P 2S8

Contacts

Premal Patel, MD, FRCSC

204-221-4476ppatel5@hsc.mb.ca

Principal Investigator:

Premal Patel, MD, FRCSC

More Information

Sponsor

University of Manitoba

Last update posted

May 5, 2026

Last verified

Jul, 2025

Keywords

  • Virtual Reality
  • TRIPP
  • Vasectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-05-05.