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NCT04836936
Auriculotherapy in the Treatment of Pre-Operative Anxiety
Conditions: Anxiety Preoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Jacques E. Chelly
Location: UPMC Shadyside Hospital Pittsburgh Pennsylvania
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04836936). StuddyBuddy aggregates publicly available trial information.
