Auriculotherapy in the Treatment of Pre-Operative Anxiety

Description

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.

Conditions

Anxiety Preoperative

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Study Overview

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Study Details

Study overview

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.

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

Auriculotherapy in the Treatment of Pre-Operative Anxiety

Condition
Anxiety Preoperative
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Shadyside Hospital, Pittsburgh, Pennsylvania, United States, 15232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Jacques E. Chelly,

Jacques E Chelly, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2025-01-31