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Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies

U

University of Manitoba

Status

Not yet enrolling

Conditions

Vasectomy
Anxiety
Pain
Virtual Reality

Treatments

Other: Treatment as usual
Device: Virtual reality (VR) guided meditation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07055178
HS26972

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Standard Vasectomy
Active Comparator group
Description:
Vasectomy treatment as usual, with local anesthetic, without virtual reality.
Treatment:
Other: Treatment as usual
Virtual Reality Vasectomy
Experimental group
Description:
This group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic.
Treatment:
Device: Virtual reality (VR) guided meditation therapy

Trial contacts and locations

1

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Central trial contact

Renée El-Gabalawy, MA, PhD, C.Psych.; Ahmed M Zalam, B.Sc.

Data sourced from clinicaltrials.gov

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