Auriculotherapy in the Treatment of Pre-Operative Anxiety
ConditionAnxiety Preoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacques E. Chelly
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Auriculotherapy cryopuncture device without nitrogen gas
- Auriculotherapy cryopuncture device with nitrogen gas
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jacques E. Chelly
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov