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Recruiting NCT07055178

NCT07055178 Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies

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Clinical Trial Summary
NCT ID NCT07055178
Status Recruiting
Phase
Sponsor University of Manitoba
Condition Vasectomy
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2025-07-02
Primary Completion 2026-08

Eligibility & Interventions

Sex Male only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Virtual reality (VR) guided meditation therapyTreatment as usual

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 90 participants in total. It began in 2025-07-02 with a primary completion date of 2026-08.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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).

Contact & Investigator

Central Contact

Renée El-Gabalawy, MA, PhD, C.Psych.

✉ renee.el-gabalawy@umanitoba.ca

📞 204-787-4083

Principal Investigator

Renée El-Gabalawy, MA, PhD, C. Psych

PRINCIPAL INVESTIGATOR

University of Manitoba

Frequently Asked Questions

Who can join the NCT07055178 clinical trial?

This trial is open to male participants only, aged 18 Years or older, studying Vasectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07055178 currently recruiting?

Yes, NCT07055178 is actively recruiting participants. Contact the research team at renee.el-gabalawy@umanitoba.ca for enrollment information.

Where is the NCT07055178 trial being conducted?

This trial is being conducted at Winnipeg, Canada.

Who is sponsoring the NCT07055178 clinical trial?

NCT07055178 is sponsored by University of Manitoba. The principal investigator is Renée El-Gabalawy, MA, PhD, C. Psych at University of Manitoba. The trial plans to enroll 90 participants.

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