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Acupuncture for Vasectomy

N/A
Recruiting
Research Sponsored by Matthew Snyder
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
Must not have
Current anxiolytic medication
Diagnosis of anxiety
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
No Placebo-Only Group

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.
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.
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 below
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I am scheduled for a vasectomy.
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I am a male over 25 years old and either active duty or a DoD beneficiary.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication for anxiety.
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I have been diagnosed with anxiety.
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I am under a pain management contract.
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I have had more than one vasectomy.
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I use medication for chronic pain or take benzodiazepines.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 • NCT01305811
2%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Acupuncture Clinical Trial Eligibility Overview. Trial Name: NCT03938415 — N/A
Infections Research Study Groups: Acupuncture, Standardized pre-procedure medications
Infections Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT03938415 — N/A
Acupuncture 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938415 — N/A
~0 spots leftby Dec 2024