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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acupuncture, Pain, Postoperative, Vasectomy

Intervention / Treatment
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* Procedure: Acupuncture
* Other: Standardized pre-procedure medications


Participation Criteria
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Eligibility Criteria
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**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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture | Procedure: Acupuncture<br>* 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.<br>|
| Active Comparator: Standardized pre-procedure medications<br>The clinic standardized pre-procedure medications alone | Other: Standardized pre-procedure medications<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |