Anxiety, Pain, Vasectomy, Virtual Reality
Conditions
Keywords
Virtual Reality, TRIPP, Vasectomy
Brief summary
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
Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.
OTHERTreatment as usual
Participants undergo a standard vasectomy.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) for Pain Severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) for Discomfort Severity | 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. |
| Numeric Rating Scale (NRS) for Anxiety Severity | 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. |
| PROMIS Pain Intensity Scale Total Score | 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). |
| State Trait Anxiety Inventory Total Score | 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) |
| National Comprehensive Cancer Network (NCCN) Anxiety Thermometer Score (adapted from Distress Thermometer) | 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. |
| Satisfaction with Surgery | 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. |
| iGroup Presence Questionnaire (IPQ) Score | 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). |
| Virtual Reality Impressions Scale | 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. |
Countries
Canada
Contacts
CONTACTRenée El-Gabalawy, MA, PhD, C.Psych.
CONTACTAhmed M Zalam, B.Sc.
PRINCIPAL_INVESTIGATORRenée El-Gabalawy, MA, PhD, C. Psych
University of Manitoba
PRINCIPAL_INVESTIGATORPremal Patel, MD, FRCSC
Manitoba Men's Health Clinic
PRINCIPAL_INVESTIGATORAhmed M Zalam, B.Sc.
University of Manitoba
Outcome results
None listed