VasectomyNCT07055178
Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies
A study testing Virtual reality (VR) guided meditation therapy and Treatment as usual in people with Vasectomy and Pain, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- Virtual reality (VR) guided meditation therapy and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Manitoba Men's Health Clinic
Winnipeg, Manitoba, R3P 2S8
Premal Patel, MD, FRCSC, 204-221-4476, ppatel5@hsc.mb.ca
Ahmed M Zalam, B.Sc., 204-880-6564, zalama@myumanitoba.ca
About this study
Official title: A Perioperative Virtual Reality Intervention for Pain and Anxiety Management During Vasectomies: A Randomized Controlled 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?
Read more
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.
- Conditions
- Vasectomy, Pain, Anxiety, Virtual Reality
- Being tested
- Virtual reality (VR) guided meditation therapy, Treatment as usual
- Keywords
- Virtual Reality, TRIPP, Vasectomy
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality (VR) guided meditation therapyDevice
Participants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset.
Treatment as usualOther
Participants undergo a standard vasectomy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Vasectomy | Active comparator | Vasectomy treatment as usual, with local anesthetic, without virtual reality. Receives: Other: Treatment as usual |
| Virtual Reality Vasectomy | Experimental | This group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic. Receives: Device: Virtual reality (VR) guided meditation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperatively (midway through procedure) and immediately following the procedure.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Within 10 minutes postoperatively (in the recovery room).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start2 Jul 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renée El-Gabalawy, University of Manitoba
- Investigators
- Renée El-Gabalawy, MA, PhD, C. Psych, Principal investigator, University of ManitobaPremal Patel, MD, FRCSC, Principal investigator, Manitoba Men's Health ClinicAhmed M Zalam, B.Sc., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055178
- Sponsor's protocol ID
- HS26972
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perioperative Virtual Reality Intervention for Pain and Anxiety Management During Vasectomies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07055178
- Acronym / sponsor ID
- HS26972
- Conditions
- Vasectomy, Pain, Anxiety, Virtual Reality
- Keywords
- Virtual Reality, TRIPP, Vasectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Vasectomy | Active comparator | Other: Treatment as usualVasectomy treatment as usual, with local anesthetic, without virtual reality. |
| Virtual Reality Vasectomy | Experimental | Device: Virtual reality (VR) guided meditation therapyThis group of participants will receive undergo their vasectomy with the virtual reality intervention alongside the local anesthetic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality (VR) guided meditation therapyParticipants will engage in the TRIPP relaxation app on the MetaQuest 3 VR headset. | Device | Virtual Reality Vasectomy |
| Treatment as usualParticipants undergo a standard vasectomy. | Other | Standard Vasectomy |
Primary outcome
Numeric Rating Scale (NRS) for Pain Severity
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.
8 secondary outcomes
Numeric Rating Scale (NRS) for Discomfort Severity
Time frame: Perioperatively (midway through procedure) and immediately following the procedure.
Numeric Rating Scale (NRS) for Anxiety Severity
Time frame: Perioperatively (midway through procedure) and immediately following the procedure.
PROMIS Pain Intensity Scale Total Score
Time frame: Within 10 minutes postoperatively (in the recovery room)
State Trait Anxiety Inventory Total Score
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)
Time frame: 10 minutes preoperatively (baseline) and within 10 minutes postoperatively (in the recovery room.
Satisfaction with Surgery
Time frame: Within 10 minutes postoperatively (in the recovery room).
iGroup Presence Questionnaire (IPQ) Score
Time frame: Within 10 minutes postoperatively (in the recovery room).
Virtual Reality Impressions Scale
Time frame: Within 10 minutes postoperatively (in the recovery room).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renée El-Gabalawy, MA, PhD, C. Psych principal investigator
University of Manitoba
Premal Patel, MD, FRCSC principal investigator
Manitoba Men's Health Clinic
Ahmed M Zalam, B.Sc. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality (VR) guided meditation therapy and Treatment as usual in people with Vasectomy and Pain, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renée El-Gabalawy, MA, PhD, C.Psych. (204-787-4083, renee.el-gabalawy@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) for Pain Severity (time frame: Perioperatively (midway through procedure) and immediately following the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.