NCT Number: NCT07055178
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Winnipeg, Manitoba, R3P 2S8, Canada
Location status: Recruiting
Ahmed M Zalam, B.Sc.
CONTACT
Ahmed M Zalam, B.Sc.
PRINCIPAL_INVESTIGATOR
Premal Patel, MD, FRCSC
CONTACT
Premal Patel, MD, FRCSC
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.
Participants undergo a standard vasectomy.
Time frame: Perioperatively (midway through procedure) and immediately following the procedure.
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.
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.
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: Within 10 minutes postoperatively (in the recovery room)
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: 10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.
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.
Brief self-report visual analogue scale (VAS) for anxiety. Scored from 0-10 ; 10 = extreme anxiety.
Time frame: Within 10 minutes postoperatively (in the recovery room).
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).
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).
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.
Contact information is provided by the study sponsor or research team.
Ahmed M Zalam, B.Sc.
CONTACT
Renée El-Gabalawy, MA, PhD, C.Psych.
CONTACT
University of Manitoba
Other
A Perioperative Virtual Reality Intervention for Pain and Anxiety Management During Vasectomies: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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