Virtual Reality for Pain and Anxiety

AM
RE
Overseen ByRenée El-Gabalawy, MA, PhD, C.Psych.
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a virtual reality (VR) program can reduce pain, anxiety, and distress for men undergoing vasectomies. Participants will either wear a VR headset with a calming meditation program during their procedure or receive standard care without VR. The trial aims to determine if VR makes the experience more comfortable and satisfying. Men who have chosen to undergo a vasectomy and feel nervous about the procedure might be a good fit for this trial. As an unphased trial, it offers participants the opportunity to explore innovative ways to enhance comfort during medical procedures.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality program is safe for reducing pain and anxiety during vasectomy?

Research has shown that using virtual reality (VR) to manage pain and anxiety is generally safe and well-tolerated. In one study, patients who used VR reported a 22.9% reduction in pain and a 45.0% decrease in anxiety, indicating VR's effectiveness with minimal side effects.

Another study focused on older adults and found that VR helped reduce pain and anxiety during medical procedures. Participants did not report any serious negative effects, suggesting VR is a safe method for managing discomfort.

Overall, these findings indicate that VR is a promising tool for easing pain and anxiety without major safety concerns.12345

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Guided Meditation Therapy for pain and anxiety during vasectomy because it offers a new way to manage discomfort without relying solely on medication. Unlike the standard use of local anesthetic alone, this approach immerses patients in a calming virtual environment, which can reduce anxiety and pain perception. The unique feature here is the use of virtual reality as a therapeutic tool, potentially enhancing patient comfort and overall experience during the procedure. This novel method could pave the way for more holistic and less invasive pain management strategies.

What evidence suggests that virtual reality is effective for reducing pain and anxiety during a vasectomy?

Research shows that virtual reality (VR) can help manage stress and anxiety. Some studies have found that using VR during medical procedures might reduce pain and anxiety by serving as a distraction. In this trial, participants in the "Virtual Reality Vasectomy" arm will undergo their vasectomy with the virtual reality intervention alongside the local anesthetic. For vasectomies, one study found that patients using VR reported feeling less pain compared to those watching regular 2D videos. However, another study found that VR did not lower pain or stress during vasectomies and even increased anxiety for some people. While VR seems promising for managing stress and improving patient experiences, its effectiveness can vary depending on the person and situation.678910

Who Is on the Research Team?

RE

Renée El-Gabalawy, MA, PhD, C. Psych

Principal Investigator

University of Manitoba

PP

Premal Patel, MD, FRCSC

Principal Investigator

Manitoba Men's Health Clinic

AM

Ahmed M Zalam, B.Sc.

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for adult men aged 18 and older who are undergoing a vasectomy with local anesthesia. It's designed to see if VR can help reduce pain, anxiety, and distress during the procedure. Participants must be willing to answer questionnaires and, if in the VR group, provide feedback on their experience.

Inclusion Criteria

Can speak and read English
I am 18 years old or older.
I have chosen to undergo a vasectomy.
See 1 more

Exclusion Criteria

Those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)
I am able to understand and give consent for my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a vasectomy with or without the VR intervention, completing questionnaires before, during, and after the procedure

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain, anxiety, and satisfaction immediately after the procedure

Within 10 minutes postoperatively
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Reality Guided Meditation Therapy
Trial Overview The study is testing whether a guided meditation program delivered through virtual reality (VR) can improve patient experiences during vasectomies compared to standard care without VR. Patients will either receive this VR intervention or undergo usual treatment while being monitored for pain and anxiety levels.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality VasectomyExperimental Treatment1 Intervention
Group II: Standard VasectomyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33387391/
Pain and anxiety during vasectomies while distracting ...The VR and 2D video glasses did not reduce pain or stress during the vasectomy. In the VR group, the anxiety levels during the procedure were even higher.
Virtual Reality and Stress Management: A Systematic ReviewThis review explores the use of virtual reality (VR) as a stress management solution, aiming to assess its viability and effectiveness in this context.
Effectiveness of Virtual Reality in Reducing Perceived Pain ...The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management.
The Effect of Virtual Reality on Anxiety During VasectomyAnother study found decrease in pain in medically treated patients (n=50 patients in 2 groups) after a 15 minute VR viewing on pain reduction compared to 2 -D ...
Virtual Reality and Stress Management: A Systematic ReviewVR has also proven to be effective in alleviating symptoms and improving outcomes for individuals dealing with both psychiatric conditions such.
The Effectiveness of Virtual Reality–Based Mindfulness ...The results showed that both interventions led to significant improvements in mindfulness, stress, and affect, with the VR group showing greater ...
Study Details | NCT07122843 | VR AI Meditation for PainThis study aims to assess changes in pain and anxiety as reported by the Pain Numeric Rating Scale (PNRS) and the State-Trait Anxiety Inventory 6 (STAI-6), ...
Effects of virtual reality on pain and anxiety in older adultsThis paper reports findings on the feasibility and efficacy of interventions delivered through VR to reduce pain and/or anxiety among older patients.
Efficacy of virtual reality for pain relief in medical proceduresOur primary outcome was pain scores measured immediately after or within an hour of the procedure. We also collected data on anxiety scores ...
The benefits and safety of a virtual reality intervention in ...Results. Patients (n = 73) reported their perceived pain intensity and anxiety reduced significantly from pre- to post-VR by 22.9% and 45.0% ...
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