Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Virtual reality (VR) guided meditation therapy
DeviceParticipants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.
Treatment as usual
Other interventionParticipants undergo a standard vasectomy.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Standard VasectomyActive comparator 1 intervention
Group B: Virtual Reality VasectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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)4
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.Sponsors and contacts
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Source ClinicalTrials.gov