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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938415
• Other study ID #: FWH20190062H
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: Jill M Clark, MBA
• Phone: 7026533298
• Email: jill.m.clark15.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years and older

Eligibility

**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

Related Conditions & MeSH terms

• Acupuncture
• Pain, Postoperative
• Vasectomy

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Snyder

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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