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

NCT03938415 | Completed

• 1 other identifier: FWH20190062H
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Pain, Postoperative; Vasectomy

Outcome Measures

Primary Outcomes (3)

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

  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

  Day 0 (2x)

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

  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

  Day 0 (2x)

• Change in Defense and Veterans Pain Rating Scale (DVPRS)

  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

  Day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture

Procedure: Acupuncture

Standardized pre-procedure medications

ACTIVE COMPARATOR

The clinic standardized pre-procedure medications alone

Other: Standardized pre-procedure medications

Interventions

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.

Acupuncture

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.

Standardized pre-procedure medications

Eligibility Criteria

• Age: 25 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew Snyder: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Las Vegas, Nevada, 89191, United States

Location

Related Publications (5)

• Wunsch JK, Klausenitz C, Janner H, Hesse T, Mustea A, Hahnenkamp K, Petersmann A, Usichenko TI. Auricular acupuncture for treatment of preoperative anxiety in patients scheduled for ambulatory gynaecological surgery: a prospective controlled investigation with a non-randomised arm. Acupunct Med. 2018 Aug;36(4):222-227. doi: 10.1136/acupmed-2017-011456. Epub 2018 Jul 9.

  PMID: 29986900 BACKGROUND

• Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 2001 Nov;93(5):1178-80, table of contents. doi: 10.1097/00000539-200111000-00024.

  PMID: 11682391 BACKGROUND

• Wang SM, Maranets I, Weinberg ME, Caldwell-Andrews AA, Kain ZN. Parental auricular acupuncture as an adjunct for parental presence during induction of anesthesia. Anesthesiology. 2004 Jun;100(6):1399-404. doi: 10.1097/00000542-200406000-00011.

  PMID: 15166558 BACKGROUND

• Thomas M, Eriksson SV, Lundeberg T. A comparative study of diazepam and acupuncture in patients with osteoarthritis pain: a placebo controlled study. Am J Chin Med. 1991;19(2):95-100. doi: 10.1142/S0192415X91000156.

  PMID: 1816730 BACKGROUND

• Sinha V, Ramasamy R. Post-vasectomy pain syndrome: diagnosis, management and treatment options. Transl Androl Urol. 2017 May;6(Suppl 1):S44-S47. doi: 10.21037/tau.2017.05.33.

  PMID: 28725617 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 6, 2019
• Study Start: June 1, 2019
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)