Auriculotherapy in the Treatment of Pre-Operative Anxiety

NCT04836936 | Recruiting FDA Device

• 1 other identifier: STUDY20120027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Preoperative

Keywords

Nephrectomy; Auriculotherapy

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Demonstrate how auriculotherapy using the cryopuncture device changes participant's total opioid consumption following nephrectomy surgery.

  Day of surgery through discharge or post-operative day 30, whichever came first

Secondary Outcomes (10)

• Pre-operative emotional distress related to anxiety

  Screening visit

• Post-operative emotional distress related to anxiety

  Day of surgery through 3 months post-operative

• Pre-operative emotional distress related to depression

  Screening visit

• Post-operative emotional distress related to depression

  Day of surgery through 3 months post-operative

• Pre-operative pain rating using the Pain Catastrophizing Scale

  Screening visit

Study Arms (2)

Auriculotherapy cryopuncture device without nitrogen gas

PLACEBO COMPARATOR

Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using an empty cryopuncture device without nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management.

Device: Auriculotherapy cryopuncture device without nitrogen gas

Auriculotherapy cryopuncture device with nitrogen gas

ACTIVE COMPARATOR

Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using a cryopuncture device with nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management.

Device: Auriculotherapy cryopuncture device with nitrogen gas

Interventions

Auriculotherapy cryopuncture device without nitrogen gas DEVICE

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 without nitrogen gas

Auriculotherapy cryopuncture device with nitrogen gas DEVICE

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).

Auriculotherapy cryopuncture device with nitrogen gas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacques E. Chelly: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Study Officials

• Jacques E Chelly, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe

CONTACT

412-623-6382; monroeal@upmc.edu

Brittany Norton

CONTACT

nortonbe@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The only person unblinded to treatment allocation will be the Principal investigator or individual who will perform the auriculotherapy treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology (with Tenure) and Orthopedic Surgery

Model Details: A Randomized, Double-Blind, Placebo-Controlled trial involving patients undergoing partial or total nephrectomy.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: April 8, 2021
• Study Start: April 13, 2021
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)