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Auriculotherapy in the Treatment of Pre-Operative Anxiety
Sponsor: 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.
Official title: Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-04-13
Completion Date
2026-06-30
Last Updated
2026-04-07
Healthy Volunteers
Yes
Conditions
Interventions
Auriculotherapy 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.
Auriculotherapy 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).
Locations (1)
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States