Acupuncture for Vasectomy Pre-procedural Anxiety and Pain Control in the Primary Care Setting

Matthew Snyder

Status: Completed

Conditions: Vasectomy; Acupuncture; Pain, Postoperative

Treatments: Other: Standardized pre-procedure medications; Procedure: Acupuncture

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03938415

FWH20190062H

Details and patient eligibility

About

This study compares auricular (ear) acupuncture and body acupuncture (Koffman protocol) versus clinic standardized pre-vasectomy medications to determine which has better outcomes at improving pre-procedural anxiety and procedural pain relief and medication usage in adult male patients following vasectomy.

Full description

The investigators will compare auricular (ear) and body acupuncture (Koffman protocol) versus clinic standardized pre-vasectomy medications to determine which has better outcomes at improving pre-procedural anxiety and procedural pain relief and medication usage in adult male patients following vasectomy. In this efficacy trial, the investigators hypothesize that acupuncture will provide therapeutic anxiety and pain relief during and after vasectomy. The investigators will measure anxiety immediately before and prior to the procedure and before and after the intervention via a standardized anxiety scale (comparative). The investigators will also measure pain control immediately after the procedure using Defense and Veterans Pain Rating Scale (DVPRS). At the post op check (2-4 days after procedure) subjects will fill out a patient satisfaction survey. During the recovery period over 2 weeks, a medication usage diary will be kept by the subject including the time when the patient returns to full duties.

Enrollment: 46 patients

Sex: Male

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

• Male active duty members and DoD beneficiaries aged 25 years or older
• Scheduled for a vasectomy

Exclusion Criteria:

• Repeat vasectomy
• Chronic pain medication/benzodiazepine use
• Current pain contract/pain management
• Current anxiolytic medication
• History of needle shock
• Diagnosis of anxiety
• Needle phobia
• Blood/injury phobia
• History of vasovagal reflex response

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Acupuncture

Treatment:

Procedure: Acupuncture

Standardized pre-procedure medications

Active Comparator group

Description:

The clinic standardized pre-procedure medications alone

Treatment:

Other: Standardized pre-procedure medications