RECRUITING

Auriculotherapy in the Treatment of Pre-Operative Anxiety

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-04-13
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04836936

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Greater than 18 years of age
  2. * Scheduled to undergo partial or full elective nephrectomy
  3. * Subject is willing and able to provide informed consent
  4. * Anxiety score ≥ 19 and ≤ 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a.
  1. * Opioid dependence, based on the DSM definition of Opioid Use Disorder (OUD)
  2. * Chronic pain condition where daily opioid use is needed
  3. * History of fibromyalgia
  4. * Anatomical malformation of ear (genetic or trauma-induced)
  5. * Vasculopathy of ear
  6. * Raynaud's disease
  7. * Patient Refusal

Contacts and Locations

Study Contact

Amy Monroe
CONTACT
412-623-6382
monroeal@upmc.edu
Brittany Norton
CONTACT
nortonbe@upmc.edu

Principal Investigator

Jacques E Chelly, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Jacques E. Chelly

  • Jacques E Chelly, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-13
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2021-04-13
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Nephrectomy
  • Auriculotherapy

Additional Relevant MeSH Terms

  • Anxiety Preoperative