Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare two groups:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Vasectomy | Active Comparator | Vasectomy treatment as usual, with local anesthetic, without virtual reality. |
|
| Virtual Reality Vasectomy | Experimental | This group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality (VR) guided meditation therapy | Device | Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Perioperatively (midway through procedure) and immediately following the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Perioperatively (midway through procedure) and immediately following the procedure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renée El-Gabalawy, MA, PhD, C.Psych. | Contact | 204-787-4083 | renee.el-gabalawy@umanitoba.ca | |
| Ahmed M Zalam, B.Sc. | Contact | 204-880-6564 | zalama@myumanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Renée El-Gabalawy, MA, PhD, C. Psych | University of Manitoba | Principal Investigator |
| Premal Patel, MD, FRCSC | Manitoba Men's Health Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manitoba Men's Health Clinic | Recruiting | Winnipeg | Manitoba | R3P 2S8 | Canada |
Study data and information from the study will not be sent outside of the University of Manitoba. Records containing health related information will be treated as confidential in accordance with Personal Health Information Act of Manitoba (PHIA). Information gathered in this research study may be published or presented in public forums, however names and other identifying personal information will not be revealed. Data will be coded and names will not be released.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment as usual | Other | Participants undergo a standard vasectomy. |
|
| 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. | 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). | 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) | 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. | 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. | 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). | 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. | Within 10 minutes postoperatively (in the recovery room). |
| Ahmed M Zalam, B.Sc. |
| University of Manitoba |
| Principal Investigator |