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NCT Number: NCT03938415

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

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.

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Key information

Conditions

Acupuncture Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Vasectomy

Age range

25 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Military Medical Center

Las Vegas, Nevada, 89191, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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

Treatment and study plan

Acupuncture

Procedure

Acupuncture involving the Koffman protocol (body acupuncture) for anxiety control (needles will be placed at bilateral LR-3, bilateral LI-4, GV 24.5 and GV 20) and Auricular ATP Plus (ear) for pain control (needles will be placed at points hippocampus, amygdala, hypothalamus, prefrontal cortex, Point Zero, Shen Men, vagus, insula, external genitalia). Subjects who tolerate the auricular needles will be offered replacement with ASP acupuncture needles for continued pain management post-procedure. The subjects will receive local anesthetic during the vasectomy per standardized clinic protocol.

Standardized pre-procedure medications

Other

The clinic standardized pre-procedure medications alone (which include diazepam 5 mg by mouth (PO) x1 30 minutes prior to the procedure, an additional 5 mg PO x1 15 minutes later if desired effect is not achieved; and oxycodone/acetaminophen 5/325 mg PO x 1 30 minutes prior to the procedure. The subjects will receive local anesthetic during the vasectomy per standardized clinic protocol.

Primary outcomes

  1. Change in Hospital Anxiety and Depression Scale (HADS) -- Medication Arm

    Time frame: 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

  2. Change in Hospital Anxiety and Depression Scale (HADS) -- Acupuncture Arm

    Time frame: 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

  3. Change in Defense and Veterans Pain Rating Scale (DVPRS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Matthew Snyder

Fed

Registry information

Official study title

Acupuncture for Vasectomy Pre-procedural Anxiety and Pain Control in the Primary Care Setting: A Randomized Comparative Effectiveness Trial

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 6, 2019
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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