Virtual Reality Technology for Vasectomy Pain Modulation

NCT05591274 | Terminated Results FDA Device

• 1 other identifier: 20220880
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether or not wearing a virtual reality (VR) headset reduces pain and anxiety in patients undergoing vasectomy. The headset being used is the SmileyScope virtual reality interface, a device already undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. In this study, the SmileyScope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy.

Conditions

Vasectomy; Pain, Postoperative; Anxiety Postoperative

Outcome Measures

Primary Outcomes (5)

• Pre-operative Anxiety

  Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]

  up to 1 day

• Post-operative Anxiety

  Anxiety will be measured via the State-Trait Anxiety Inventory (STAI) anxiety score \[Range 20-80; 20 = low anxiety, 80 = high anxiety\]

  up to 1 day

• Subjective Pre-operative Pain

  Pain will be measured via numeric Likert pain scale \[0-10; 0 = no pain, 10 = highest pain\]

  up to 1 day

• Subjective Post-operative Pain

  Pain will be measured via numeric Likert pain scale; compared to baseline pain scale in pre-operative period \[0-10; 0 = no pain, 10 = highest pain\]

  up to 1 day

• Post-procedure Satisfaction

  Satisfaction will be measured via a questionnaire scored by Likert scale. Questionnaire will ask: "How satisfied were you with today's procedure, with 0 being not satisfied at all, and 10 being the most satisfied?" "How helpful was VR in managing your vasectomy today" (0 is least helpful, 10 is most helpful)"

  up to 1 day

Secondary Outcomes (6)

• Physiological Intra-operative Heart Rate

  up to 1 day

• Physiological Intra-operative Oxygen Saturation

  up to 1 day

• Physiological Intra-operative Skin Temperature

  up to 1 day

• Physiological Post-operative Heart Rate

  up to 1 day

• Physiological Post-operative Oxygen Saturation

  up to 1 day

Study Arms (3)

Interactive VR

EXPERIMENTAL

Patients will be wearing a virtual reality headset preloaded with an interactive VR scenario.

Device: SmileyScope Virtual Reality Headset

Static VR

EXPERIMENTAL

Patients will be wearing a virtual reality headset preloaded with a static, non-interactive VR scenario.

Device: SmileyScope Virtual Reality Headset

Control

NO INTERVENTION

Patients will not be wearing any virtual reality headset.

Interventions

SmileyScope Virtual Reality Headset DEVICE

The SmileyScope Virtual Reality Headset is a VR headset undergoing study for approval by the U.S. Food and Drug Administration (FDA) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. Currently, this device has been granted entrance to the FDA Safer Technologies Program. The device comes pre-loaded with either an interactive or static virtual reality scenario.

Interactive VR; Static VR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males 18 years or older who are undergoing elective vasectomy

You may not qualify if:

• Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study
• History of chronic pain disorder or chronic narcotic use
• Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancer, etc. which could compromise the physical function of the headset.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Desai Sethi Urology Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Russell Saltzman
• Organization: University of Miami, Miller School of Medicine

R.Saltzman@med.miami.edu

3052431152

Study Officials

• Farhan Qureshi, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality). Randomization sequence will be generated using a validated random number generator, and allocation concealment will be achieved via opaque envelope. Treatment (vasectomy with interactive VR, vasectomy with static VR, or vasectomy with no VR) will be known to patient and care provider only once the vasectomy procedure begins.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into one of three groups (interactive virtual reality, static virtual reality, and no virtual reality).

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 24, 2022
• Study Start: November 17, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)