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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.
Participants undergo a standard vasectomy.
Manitoba Men's Health Clinic
Winnipeg, Manitoba, Canada
Numeric Rating Scale (NRS) for Pain Severity
During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute pain, this is on a scale of 0-10; 10 = most severe pain.
Time frame: Perioperatively (midway through procedure) and immediately following the procedure.
Numeric Rating Scale (NRS) for Discomfort Severity
During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute discomfort, this is on a scale of 0-10; 10 = most severe pain.
Time frame: Perioperatively (midway through procedure) and immediately following the procedure.
Numeric Rating Scale (NRS) for Anxiety Severity
During and immediately following the procedure, patients will be momentarily interrupted to give a brief NRS verbal response question measure of their level of acute anxiety, this is on a scale of 0-10; 10 = most severe pain.
Time frame: Perioperatively (midway through procedure) and immediately following the procedure.
PROMIS Pain Intensity Scale Total Score
Immediately following the procedure, patients will be asked to respond to a short verbal Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity questionnaire with questions surrounding experienced pain (scored 3 - 15 ; 15 = greatest pain severity).
Time frame: Within 10 minutes postoperatively (in the recovery room)
State Trait Anxiety Inventory Total Score
Brief self-report questionnaire with questions surrounding anxiety traits (scale 0-63 ; 63 = most severe anxiety)
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)
Brief self-report visual analogue scale (VAS) for anxiety. Scored from 0-10 ; 10 = extreme anxiety.
Time frame: 10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.
Satisfaction with Surgery
Brief self-report item to assess overall satisfaction with their procedure. Scaled from 0-10 ; 10 = greatest satisfaction.
Time frame: Within 10 minutes postoperatively (in the recovery room).
iGroup Presence Questionnaire (IPQ) Score
Brief self-report questionnaire with several questions surrounding VR experience (spatial presence, involvement, and experience realism). Each question is scored independently on a 7-point Likert scale (from -3 to +3).
Time frame: Within 10 minutes postoperatively (in the recovery room).
Virtual Reality Impressions Scale
Brief self-report questionnaire with several questions surrounding the virtual reality program experience (spatial presence, involvement, and experience realism). Each question is scored independently on a 0 - 10 scale ; 0 = complete disagreement, 10 = complete agreement.
Time frame: Within 10 minutes postoperatively (in the recovery room).
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