RecruitingNot ApplicableNCT04836936

Auriculotherapy in the Treatment of Pre-Operative Anxiety

Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial


Sponsor

Jacques E. Chelly

Enrollment

60 participants

Start Date

Apr 13, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether auriculotherapy — a technique that stimulates specific pressure points on the ear — can reduce anxiety before kidney surgery. Researchers want to see if this non-drug approach can help calm patients in the days leading up to their procedure. **You may be eligible if:** - You are over 18 years old - You are scheduled to have part or all of a kidney removed (nephrectomy) - You have mild to moderate anxiety based on a validated questionnaire score - You are willing and able to give your consent to participate **You may NOT be eligible if:** - You have a dependence on opioids or a diagnosed opioid use disorder - You need opioids daily to manage chronic pain - You have a history of fibromyalgia - You have a physical abnormality of the ear (from birth or injury), poor blood flow to the ear, or Raynaud's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

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NCT04836936


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