Status:
RECRUITING
Auriculotherapy in the Treatment of Pre-Operative Anxiety
Lead Sponsor:
Jacques E. Chelly
Conditions:
Anxiety Preoperative
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Sixty subjects undergoing total or partial nephrectomies will be asked to participate in this IRB approved placebo-controlled randomized study. Potential subjects will be recruited out of the surgeon'...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04836936
Start Date
April 13 2021
End Date
March 30 2026
Last Update
January 8 2026
Active Locations (1)
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1
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232