Actively Recruiting
Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial
Led by Jacques E. Chelly · Updated on 2026-06-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how auriculotherapy, a treatment involving stimulation of the ear using a cryopuncture device, may reduce anxiety before surgery and lower opioid use after surgery in patients undergoing partial or total nephrectomy for cancer. This randomized, placebo-controlled trial aims to establish whether auriculotherapy can better reduce perioperative anxiety compared to a placebo and potentially decrease the risk of opioid use disorders linked to surgical anxiety. Participants will be randomly assigned to receive either active auriculotherapy with nitrogen gas or a placebo version without nitrogen gas. Treatment is done in the pre-operative setting within one hour before surgery after a peripheral nerve block. The active treatment involves applying nitrogen gas bursts to specific points on the ear, while the placebo mimics the procedure without releasing gas. Both groups will receive standard care for surgery and post-operative pain management. Participants will complete anxiety and depression questionnaires before surgery and after discharge, along with pain and satisfaction assessments. Daily diaries will track pain, anxiety levels, and opioid use for one week post-surgery. Follow-up calls will collect data on emotional distress and functional recovery at 30 and 90 days after surgery. The main outcome measured is opioid consumption from the day of surgery until discharge or 30 days post-op, with ongoing safety and symptom monitoring throughout the study period.
CONDITIONS
Brief Title
Auriculotherapy in the Treatment of Pre-Operative Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Greater than 18 years of age
- Scheduled to undergo partial or full elective nephrectomy
- Willing and able to provide informed consent
- Anxiety score between 19 and 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a
You will not qualify if you...
- Opioid dependence based on DSM definition of Opioid Use Disorder
- Chronic pain condition requiring daily opioid use
- History of fibromyalgia
- Anatomical malformation of ear due to genetics or trauma
- Vasculopathy of the ear
- Raynaud's disease
- Patient refusal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 day
Participants receive auriculotherapy treatment using a cryopuncture device with or without nitrogen gas in the pre-operative setting within one hour before surgery after a peripheral nerve block.
1 visit (in-person, pre-operative)
Duration - Up to 3 months post-operative
Participants are assessed for pain medication use and pain scores daily until discharge, complete questionnaires at discharge, and keep a diary recording daily pain, anxiety, and analgesic use for one week after surgery. They will be contacted daily by phone for the first week post-op and also once at 30 and 90 days post-op for follow-up questionnaires.
Daily contact for 7 days and phone calls at 30 and 90 days post-op
Trial Site Locations
Total: 1 location
1
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
H
Heather Margonari
A
Akbota Ayazbekova, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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