Auriculotherapy for Pre-Operative Anxiety
Recruiting in Palo Alto (17 mi)
Overseen byJacques E Chelly, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jacques E. Chelly
Must not be taking: Opioids
Disqualifiers: Opioid dependence, Chronic pain, Fibromyalgia, others
Trial Summary
What is the purpose of 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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for pre-operative anxiety?
Research shows that auricular acupuncture, which is part of auriculotherapy, can help reduce anxiety before medical procedures like dental treatments and surgeries. This suggests it might also be helpful for pre-operative anxiety.
12345Is auriculotherapy generally safe for humans?
Auriculotherapy, including ear acupuncture, is generally considered safe with rare complications. Most reported side effects are mild and temporary, such as pain at the needle site, minor bleeding, dizziness, and nausea.
12467How does auriculotherapy differ from other treatments for pre-operative anxiety?
Auriculotherapy is unique because it involves stimulating specific points on the ear, which may activate the parasympathetic nervous system to reduce anxiety. Unlike traditional medications, it uses a cryopuncture device with or without nitrogen gas, offering a non-invasive alternative that doesn't rely on drugs.
14589Eligibility Criteria
This trial is for adults over 18 who are feeling anxious (with specific anxiety scores) and are about to have kidney cancer surgery. They must understand and agree to the study's process. People with fibromyalgia, ear problems, poor blood flow in the ears, Raynaud's disease, opioid addiction or those needing daily opioids for chronic pain can't join.Inclusion Criteria
Anxiety score ≥ 19 and ≤ 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a.
I am older than 18 years.
Subject is willing and able to provide informed consent
+1 more
Exclusion Criteria
I have been diagnosed with fibromyalgia.
I have an ear shape issue due to genetics or injury.
You are dependent on opioid drugs, which means you have a condition called Opioid Use Disorder (OUD).
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Pre-operative Assessment
Participants complete PROMIS Emotional Distress and Pain Catastrophizing Scale questionnaires to assess eligibility and baseline anxiety and depression levels
1 day
1 visit (in-person)
Treatment
Auriculotherapy treatment with or without nitrogen gas is administered in the pre-operative setting
1 day
1 visit (in-person)
Post-operative Monitoring
Participants are assessed for pain medication requirement and pain scores in the post-anesthesia care unit (PACU) and daily until discharge
Up to 1 week
Daily assessments (in-person)
Follow-up
Participants are monitored for emotional distress, pain, and opioid consumption through questionnaires and phone calls
3 months
Daily phone calls for 1 week, then at 30-day and 90-day post-op
Participant Groups
The study tests auriculotherapy—a type of acupuncture using cold temperatures—to see if it reduces anxiety before surgery. Participants will receive this therapy with or without nitrogen gas and their anxiety levels will be measured before and after treatment.
2Treatment groups
Active Control
Placebo Group
Group I: Auriculotherapy cryopuncture device with nitrogen gasActive Control1 Intervention
Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using a cryopuncture device with nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management.
Group II: Auriculotherapy cryopuncture device without nitrogen gasPlacebo Group1 Intervention
Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using an empty cryopuncture device without nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UPMC Shadyside HospitalPittsburgh, PA
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Who Is Running the Clinical Trial?
Jacques E. ChellyLead Sponsor
References
Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]Auricular acupuncture (AA) and extended auricular therapy (AT) are a part of acupuncture practice shown to benefit patients with pain, anxiety, and other conditions, with cost-effective access enhanced when given in a group setting. Yet there are safety concerns and risks, perhaps unnecessary risks, that attend embedded, indwelling needles applied to the ear as a means of extended AT.
Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. [2021]The objective of this study was to analyse whether auricular acupuncture, acupuncture at the outer ear, could reduce state anxiety before dental treatment.
Auriculotherapy to control chemotherapy-induced nausea and vomiting in patients with cancer: protocol of a systematic review. [2023]Due to the worldwide rise in cancer incidence, and therefore the rise in the need for antineoplastic chemotherapy, it is important for both healthcare professionals and patients alike that the side effects of chemotherapy, such as chemotherapy-induced nausea and vomiting (CINV), are treated and prevented. Auriculotherapy is a type of acupuncture and may be a low-cost and safe antiemetic measure to control the side effects of chemotherapy. The goal of this systematic review is to synthesize the available evidence in the literature regarding the auriculotherapy effects to treat CINV in people with cancer.
Auricular acupuncture for treatment of preoperative anxiety in patients scheduled for ambulatory gynaecological surgery: a prospective controlled investigation with a non-randomised arm. [2019]Auricular acupuncture (AA) is a promising alternative treatment for situational anxiety. The aim of this pilot investigation was to test the acceptability and feasibility of AA as a treatment for preoperative anxiety (PA) in preparation for a subsequent randomised controlled trial.
The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. [2023]Auricular therapy includes acupuncture, electroacupuncture, acupressure, lasering, cauterization, moxibustion, and bloodletting in the auricle. For 2500 years, people have employed auricular therapy for treating diseases, but the methods have been limited to bloodletting and cauterization. Only after 1957, the international scientific community became aware that the map of the ear resembles an inverted fetus, its introduction has led to auricular acupuncture (AA) becoming a more systemic approach, and, following the identification and standardization of more precise points, AA has been employed in clinical applications. The mechanisms of AA are considered to have a close relationship with the autonomic nervous system, the neuroendocrine system, neuroimmunological factors, neuroinflammation, and neural reflex, as well as antioxidation. Auricular therapy has been applied, for example, for pain relief, for the treatment of epilepsy, anxiety, and obesity, and for improving sleep quality. However, the mechanisms and evidence for auricular therapy warrant further study.
Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. [2023]Label="Background" NlmCategory="UNASSIGNED">Auricular acupuncture (AA) is commonly used by acupuncturists as stand-alone therapy or as an adjunctive to body acupuncture. AA is considered to be safe, with rare complications. The most commonly reported complications are usually transient and include: pain at insertion; minor bleeding; local tenderness; dizziness; and nausea. No reported cases of an Aiguille Semi-Permanente® (ASP®) needle retained in the external auditory canal (EAC) has been found in the medical literature.
Adverse events of auricular therapy: a systematic review. [2022]The aim of this study was to systematically evaluate the literature on adverse events associated with auricular therapy (AT). Case reports, case series, surveys, and all types of clinical trials reporting adverse events of AT were included. Relevant articles were mainly retrieved from 13 electronic databases and seven Chinese journals on complementary medicine. AT-related adverse events were reported in 32 randomized controlled trials, five uncontrolled clinical trials, four case reports, and two controlled clinical trials. For auricular acupuncture, the most frequently reported adverse events were tenderness or pain at insertion, dizziness, local discomfort, minor bleeding and nausea, and so forth. For auricular acupressure, local skin irritation and discomfort, mild tenderness or pain, and dizziness were commonly reported. Skin irritation, local discomfort, and pain were detected in auricular electroacupuncture, and minor infection was identified in auricular bloodletting therapy. Most of these events were transient, mild, and tolerable, and no serious adverse events were identified. Our findings provide preliminary evidence that AT is a relatively safe approach. Considering the patient's safety, prospective or retrospective surveys are needed in future research to gather practitioner-reported and patient-reported adverse events on AT, and the quality of adverse events reporting in future AT trials should be improved.
Comparing the treatment effectiveness of body acupuncture and auricular acupuncture in preoperative anxiety treatment. [2021]Preoperative anxiety has become more frequent in preoperative patients and can bring negative impact on operation outcomes. Many studies have reported the effect of body acupuncture in reducing anxiety syndromes. The aim of this study is to compare the treatment effect of body acupuncture and auricular acupuncture in preoperative patients with preoperative anxiety.
The Effect of Auriculotherapy on Situational Anxiety Trigged by Examinations: A Randomized Pilot Trial. [2022]Auriculotherapy may activate the parasympathetic nerve system and reduce anxiety levels. Short-term auriculotherapy's effects and safety on university students' anxiety levels was assessed prior to exams.