VasectomyNCT04258514
The Effect of Virtual Reality on Anxiety During Vasectomy
A study testing Virtual Reality during vasectomy and Standard Vasectomy in people with Vasectomy and Virtual Reality, run by University of Nebraska.
Trial summary
The primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility… Read more about this study
- Who is it for?
- Ages 19 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vasectomy, Virtual Reality
- What is being tested?
- Virtual Reality during vasectomy and Standard Vasectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Appropriate age range (19-100 years)
- Undergoing elective vasectomy procedure in the urology clinic
- Willing to sign consent to participate in the study
Who cannot join
- Visually impaired (blind)
- 18 years of age or younger
- Subjects under the influence of medications will not be approached regarding study participation.
About this study
The primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility; c.) acceptance of wearing goggles; d) able to provide informed consent.There will be two groups, Group A will wear VR goggles and Group B will not. Evaluations will be done by survey to include questions regarding the level of anxiety experienced during the procedure, along with satisfaction scores of the experience.
Read the detailed description
- The aim of the study is to evaluate the efficacy of virtual reality goggles (VRG) for improving the patient's experience during vasectomy procedure.
- The secondary aim is to determine if VRG reduces the level of anxiety experienced during vasectomy procedure.
VR is an immersive, multisensory experience in a three-dimensional environment designed to replicate a real world. It has been shown in multiple studies to decrease acute and chronic pain in a variety of clinical settings. The mechanism is due to distraction by activating visual, auditory and proprioceptive senses. One example of this is a report by G. Pooja et. al. where in VR goggles reduced pain and medication use during orthopedic procedures (1). Another 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 viewing (2).
- Conditions
- Vasectomy, Virtual Reality
- Being tested
- Virtual Reality during vasectomy, Standard Vasectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality during vasectomyProcedure or surgery
Virtual Reality
Standard VasectomyProcedure or surgery
No Virtual Reality
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Vasectomy | Experimental | This group of men will undergo vasectomy while wearing VR goggles. Receives: Procedure: Virtual Reality during vasectomy |
| Standard Vasectomy | Experimental | This group of men will undergo a standard vasectomy without using VR goggles. Receives: Procedure: Standard Vasectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure anxiety
Procedure anxiety measured by Beck Anxiety Inventory
Measured: during vasectomy Procedure
Procedure anxiety
Procedure anxiety measured by Beck Anxiety Inventory
Measured: 10 minutes prior to procedure start
Procedure anxiety
Procedure anxiety measured by Beck Anxiety Inventory
Measured: 10 minutes after procedure ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Apr 2021
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Why it stopped: Similar study published prior to beginning enrollment and we did not anticipate adding new information based on that study
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 NebraskaThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher M Deibert, MD, MPH, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258514
- Sponsor's protocol ID
- 0034-20-EP
- Status last verified
- Aug 2023
- First submitted
- 31 Jan 2020
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Anxiety During Vasectomy
- ClinicalTrials.gov ID
- NCT04258514
- Acronym / sponsor ID
- 0034-20-EP
- Conditions
- Vasectomy, Virtual Reality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar study published prior to beginning enrollment and we did not anticipate adding new information based on that study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 6 Feb 2020 (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 primary purpose of the study is to determine if the use of Virtual Reality (VR) goggles reduces the degree of anxiety patients experience during vasectomy procedures. The eligibility criteria include a.) appropriate age (19-100 years); b.) undergoing elective vasectomy procedure for purpose of desired sterility; c.) acceptance of wearing goggles; d) able to provide informed consent.There will be two groups, Group A will wear VR goggles and Group B will not. Evaluations will be done by survey to include questions regarding the level of anxiety experienced during the procedure, along with satisfaction scores of the experience.
Detailed description
- The aim of the study is to evaluate the efficacy of virtual reality goggles (VRG) for improving the patient's experience during vasectomy procedure.
- The secondary aim is to determine if VRG reduces the level of anxiety experienced during vasectomy procedure.
VR is an immersive, multisensory experience in a three-dimensional environment designed to replicate a real world. It has been shown in multiple studies to decrease acute and chronic pain in a variety of clinical settings. The mechanism is due to distraction by activating visual, auditory and proprioceptive senses. One example of this is a report by G. Pooja et. al. where in VR goggles reduced pain and medication use during orthopedic procedures (1). Another 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 viewing (2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Vasectomy | Experimental | Procedure: Virtual Reality during vasectomyThis group of men will undergo vasectomy while wearing VR goggles. |
| Standard Vasectomy | Experimental | Procedure: Standard VasectomyThis group of men will undergo a standard vasectomy without using VR goggles. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Appropriate age range (19-100 years)
- Undergoing elective vasectomy procedure in the urology clinic
- Willing to sign consent to participate in the study
Key exclusion criteria (3 listed)
- Visually impaired (blind)
- 18 years of age or younger
- Subjects under the influence of medications will not be approached regarding study participation.
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 during vasectomyVirtual Reality | Procedure or surgery | Virtual Reality Vasectomy |
| Standard VasectomyNo Virtual Reality | Procedure or surgery | Standard Vasectomy |
Primary outcome
Procedure anxiety
Time frame: during vasectomy Procedure
Procedure anxiety measured by Beck Anxiety Inventory
Procedure anxiety
Time frame: 10 minutes prior to procedure start
Procedure anxiety measured by Beck Anxiety Inventory
Procedure anxiety
Time frame: 10 minutes after procedure ends
Procedure anxiety measured by Beck Anxiety Inventory
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Vasectomy
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception
RecruitingPhase 2
Plan A Occlusion and Reversal System Feasibility Study
Fertility, Fertility, Male
RecruitingPhase 1
Post-Vasectomy Pain Study
Vasectomy, NSAIDs
Recruiting
Perioperative Virtual Reality Intervention for Pain and Anxiety During Vasectomies
Vasectomy, Pain
RecruitingPhase 1/2
Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
Male Contraception
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. This study is not recruiting at the moment.
Christopher M Deibert, MD, MPH principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality during vasectomy and Standard Vasectomy in people with Vasectomy and Virtual Reality, run by University of Nebraska.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure anxiety (time frame: during vasectomy Procedure). The study lists 3 primary outcomes in all. 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 15 Aug 2023.