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

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ClinicalTrials.gov Identifier: NCT03938415
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Snyder, Mike O'Callaghan Military Hospital

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.

Condition or disease Intervention/treatment Phase
Acupuncture Pain, Postoperative Vasectomy Procedure: Acupuncture Other: Standardized pre-procedure medications Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Vasectomy Pre-procedural Anxiety and Pain Control in the Primary Care Setting: A Randomized Comparative Effectiveness Trial
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture
Procedure: Acupuncture
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.

Active Comparator: Standardized pre-procedure medications
The clinic standardized pre-procedure medications alone
Other: Standardized pre-procedure medications
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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938415


Contacts
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Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil
Contact: Amanda J Crawford, BA 7026532113 amanda.j.crawford.ctr@mail.mil

Locations
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United States, Nevada
Mike O'Callaghan Military Medical Center Recruiting
Las Vegas, Nevada, United States, 89191
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Sponsors and Collaborators
Matthew Snyder
  Study Documents (Full-Text)

Documents provided by Matthew Snyder, Mike O'Callaghan Military Hospital:
Informed Consent Form  [PDF] January 22, 2019


Publications:
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Responsible Party: Matthew Snyder, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT03938415     History of Changes
Other Study ID Numbers: FWH20190062H
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan on sharing data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms