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

Not Applicable

Completed

• Conditions: Acupuncture; Pain, Postoperative; Vasectomy
• Interventions: Other: Standardized pre-procedure medications; Procedure: Acupuncture

• Registration Number: NCT03938415
• Lead Sponsor: Matthew Snyder

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-06-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-11
• Study Completion: 2025-04-11
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized pre-procedure medications	Standardized pre-procedure medications	The clinic standardized pre-procedure medications alone
Acupuncture	Acupuncture	Acupuncture

Primary Outcome Measures

Name	Time	Method
Change in Defense and Veterans Pain Rating Scale (DVPRS)	Day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Change in Hospital Anxiety and Depression Scale (HADS) -- Medication Arm	Day 0 (2x)	The HADS is a self-rating scale developed to assess psychological distress in non-psychiatric patients. It consists of two subscales, Anxiety and Depression, each having seven items and a score range of 0 to 21. The HADS has been satisfactorily used in the general population and a number of clinical settings. A score less than 8 is considered as being normal, 8 to 10 as suggestive of anxiety or depression, and greater than 11 as being probable of anxiety or depression. The HADS score is ordinal and will be analyzed using nonparametric methods
Change in Hospital Anxiety and Depression Scale (HADS) -- Acupuncture Arm	Day 0 (2x)	The HADS is a self-rating scale developed to assess psychological distress in non-psychiatric patients. It consists of two subscales, Anxiety and Depression, each having seven items and a score range of 0 to 21. The HADS has been satisfactorily used in the general population and a number of clinical settings. A score less than 8 is considered as being normal, 8 to 10 as suggestive of anxiety or depression, and greater than 11 as being probable of anxiety or depression. The HADS score is ordinal and will be analyzed using nonparametric methods

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Las Vegas, Nevada, United States