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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Auriculotherapy cryopuncture device without nitrogen gas
DeviceAuriculotherapy cryopuncture device without nitrogen gas will be administered. Application of this placebo device will be performed in the same manner as the treatment, but without the expulsion of nitrogen gas.
Auriculotherapy cryopuncture device with nitrogen gas
DeviceAuriculotherapy cryopuncture device with nitrogen gas will be administered. The tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of nitrogen gas for 2 seconds on each point (6 points total).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Auriculotherapy cryopuncture device without nitrogen gasPlacebo comparator 1 intervention
Group B: Auriculotherapy cryopuncture device with nitrogen gasActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid Consumption
Demonstrate how auriculotherapy using the cryopuncture device changes participant's total opioid consumption following nephrectomy surgery.
Time frame
Day of surgery through discharge or post-operative day 30, whichever came firstSecondary outcomes
1
Pre-operative emotional distress related to anxiety
Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time frame
Screening visit2
Post-operative emotional distress related to anxiety
Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time frame
Day of surgery through 3 months post-operative3
Pre-operative emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant many have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time frame
Screening visit4
Post-operative emotional distress related to depression
Post-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire. There are 8 questions about how the participant many have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time frame
Day of surgery through 3 months post-operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jacques E. Chelly
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov