Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial
Jacques E. Chelly
Summary
The goal of this clinical trial is to use the validated PROMIS Emotional Distress - Anxiety - Short Form 8a and PROMIS Emotional Distress-Depression-Short Form pre-and post-intervention to establish a superior correlation between the auriculotherapy treatment and the reduction of perioperative anxiety. Subject population will include those having a partial or total nephrectomy for cancer. Drawing the role that auriculotherapy may play in reducing perioperative anxiety related requirement after surgery may also help in reducing the risk of opioid use disorders (OUD) since anxiety has been found to be a major risk factor for OUD in surgical patients. Therefore, this trial will also examine the effect of the auriculotherapy intervention in reducing opioid requirement after surgery.
Description
Sixty subjects undergoing total or partial nephrectomies will be asked to participate in this IRB approved placebo-controlled randomized study. Potential subjects will be recruited out of the surgeon's office or at a preoperative clinical visit prior to surgery. The clinical care team will introduce the study and request permission for the research team to speak with the patient. If the subject agrees to be approached by a member of the research team, then the research team will approach the subject. During the Informed Consent, a PI or Co-I will be available to answer final questions and faci…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Greater than 18 years of age * Scheduled to undergo partial or full elective nephrectomy * Subject is willing and able to provide informed consent * Anxiety score ≥ 19 and ≤ 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a. Exclusion Criteria: * Opioid dependence, based on the DSM definition of Opioid Use Disorder (OUD) * Chronic pain condition where daily opioid use is needed * History of fibromyalgia * Anatomical malformation of ear (genetic or trauma-induced) * Vasculopathy of ear * Raynaud's disease * Patient Refusal
Interventions
- DeviceAuriculotherapy cryopuncture device without nitrogen gas
Auriculotherapy cryopuncture device without nitrogen gas will be administered. Application of this placebo device will be performed in the same manner as the treatment, but without the expulsion of nitrogen gas.
- DeviceAuriculotherapy cryopuncture device with nitrogen gas
Auriculotherapy cryopuncture device with nitrogen gas will be administered. The tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of nitrogen gas for 2 seconds on each point (6 points total).
Location
- UPMC Shadyside HospitalPittsburgh, Pennsylvania