Clinical trial NCT03938415: Acupuncture for Vasectomy Pre-procedural Anxiety and Pain Control in the Primary Care Setting
Official title: Acupuncture for Vasectomy Pre-procedural Anxiety and Pain Control in the Primary Care Setting: A Randomized Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Pain, Postoperative
Vasectomy
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2019-05-06
Enrollment: 46
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS) -- Medication Arm
timeFrame: Day 0 (2x)
measure: Change in Hospital Anxiety and Depression Scale (HADS) -- Acupuncture Arm
timeFrame: Day 0 (2x)
measure: Change in Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Day: 0 (pre-procedure), 0 (post-procedure),1,2,3,4,5,6,7,8,9,10,11,12,13,14
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
References:
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.
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.
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.
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.
citation: 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.