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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled for a vasectomy
Male active duty members and DoD beneficiaries aged 25 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14
Awards & highlights
Study Summary
This trial found that acupuncture was better than medication for reducing anxiety and pain before and after vasectomy.
Who is the study for?
This trial is for male active duty members and DoD beneficiaries, aged 25 or older, who are scheduled for a vasectomy at Nellis Air Force Base. It's not open to those with blood/injury phobia, anxiety disorders, needle shock history, on anxiolytics or chronic pain meds, or with past vasovagal responses.Check my eligibility
What is being tested?
The study is testing if auricular (ear) acupuncture and body acupuncture following the Koffman protocol can better manage pre-procedural anxiety and pain during a vasectomy compared to standard pre-procedure medications given in clinics.See study design
What are the potential side effects?
While the side effects of acupuncture are generally minimal, they may include slight bleeding or bruising at needle sites, mild discomfort during needle insertion, dizziness or fainting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a vasectomy.
Select...
I am a male over 25 years old and either active duty or a DoD beneficiary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Defense and Veterans Pain Rating Scale (DVPRS)
Change in Hospital Anxiety and Depression Scale (HADS) -- Acupuncture Arm
Change in Hospital Anxiety and Depression Scale (HADS) -- Medication Arm
Side effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AcupunctureExperimental Treatment1 Intervention
Acupuncture
Group II: Standardized pre-procedure medicationsActive Control1 Intervention
The clinic standardized pre-procedure medications alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
Matthew SnyderLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of fainting in response to certain triggers.I am scheduled for a vasectomy.You have a fear of blood or getting injured.I am currently taking medication for anxiety.You are scared of needles.I am a male over 25 years old and either active duty or a DoD beneficiary.I have been diagnosed with anxiety.You have a history of being afraid of needles or getting scared when seeing needles.I am under a pain management contract.I have had more than one vasectomy.I use medication for chronic pain or take benzodiazepines.
Research Study Groups:
This trial has the following groups:- Group 1: Acupuncture
- Group 2: Standardized pre-procedure medications
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on patient enrollment in this research project?
"Indeed, the details hosted on clinicaltrials.gov suggest that this experiment is currently seeking enrollees. Initially posted on June 1st 2019, it was most recently amended on April 5th 2022 and requires 85 participants from one site."
Answered by AI
Is this program still open for enrolment?
"Affirmative. Clinicaltrials.gov affirms that the trial, which was first published on June 1st 2019 is still recruiting patients into its study cohort of 85 individuals at a single location."
Answered by AI
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