Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies

NCT ID: NCT07055178

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vasectomy Pain Anxiety Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Vasectomy

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

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Participants undergo a standard vasectomy.

Virtual Reality Vasectomy

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

Group Type EXPERIMENTAL

Virtual reality (VR) guided meditation therapy

Intervention Type DEVICE

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

Interventions

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Virtual reality (VR) guided meditation therapy

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

Intervention Type DEVICE

Treatment as usual

Participants undergo a standard vasectomy.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Renée El-Gabalawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renée El-Gabalawy, MA, PhD, C. Psych

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Premal Patel, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Manitoba Men's Health Clinic

Ahmed M Zalam, B.Sc.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Manitoba Men's Health Clinic

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Central Contacts

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Renée El-Gabalawy, MA, PhD, C.Psych.

Role: CONTACT

204-787-4083

Ahmed M Zalam, B.Sc.

Role: CONTACT

204-880-6564

Facility Contacts

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Premal Patel, MD, FRCSC

Role: primary

204-221-4476

Ahmed M Zalam, B.Sc.

Role: backup

204-880-6564

Other Identifiers

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HS26972

Identifier Type: -

Identifier Source: org_study_id

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