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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Pennsylvania
UPMC Shadyside Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Amy Monroe
monroeal@upmc.edu
412-623-6382
Backup
Brittany Norton
nortonbe@upmc.edu
Time Frame
Start Date: 2021-04-13
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Auriculotherapy cryopuncture device without nitrogen gas
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.
Active_comparator: Auriculotherapy cryopuncture device with nitrogen gas
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.
Related Therapeutic Areas
Sponsors
Leads: Jacques E. Chelly

This content was sourced from clinicaltrials.gov