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Recruiting NCT07055178

Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies

No phase Interventional Vasectomy Pain Anxiety Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality (VR) guided meditation therapy, Treatment as usual.
Who it may be relevant to
Registry conditions: Vasectomy, Pain, Anxiety, Virtual Reality. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Perioperative Virtual Reality Intervention for Pain and Anxiety Management During Vasectomies: A Randomized Controlled Trial

Overview

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.

Interventions

  • Device Virtual reality (VR) guided meditation therapy
    Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.
  • Other Treatment as usual
    Participants undergo a standard vasectomy.

Primary outcome measures

  • Numeric Rating Scale (NRS) for Pain Severity [Time frame: Perioperatively (midway through procedure) and immediately following the procedure.]
Secondary outcome measures (8)
  • Numeric Rating Scale (NRS) for Discomfort Severity [Time frame: Perioperatively (midway through procedure) and immediately following the procedure.]
  • Numeric Rating Scale (NRS) for Anxiety Severity [Time frame: Perioperatively (midway through procedure) and immediately following the procedure.]
  • PROMIS Pain Intensity Scale Total Score [Time frame: Within 10 minutes postoperatively (in the recovery room)]
  • State Trait Anxiety Inventory Total Score [Time frame: 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) [Time frame: 10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.]
  • Satisfaction with Surgery [Time frame: Within 10 minutes postoperatively (in the recovery room).]
  • iGroup Presence Questionnaire (IPQ) Score [Time frame: Within 10 minutes postoperatively (in the recovery room).]
  • Virtual Reality Impressions Scale [Time frame: Within 10 minutes postoperatively (in the recovery room).]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Manitoba Men's Health Clinic — Winnipeg

Identifiers

NCT: NCT07055178 · HS26972

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗