NCT04836936 Auriculotherapy in the Treatment of Pre-Operative Anxiety
| NCT ID | NCT04836936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jacques E. Chelly |
| Condition | Anxiety Preoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-04-13 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-04-13 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jacques E Chelly, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT04836936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety Preoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04836936 currently recruiting?
Yes, NCT04836936 is actively recruiting participants. Contact the research team at margonarih@chp.edu for enrollment information.
Where is the NCT04836936 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04836936 clinical trial?
NCT04836936 is sponsored by Jacques E. Chelly. The principal investigator is Jacques E Chelly, MD at University of Pittsburgh. The trial plans to enroll 60 participants.
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