Auriculotherapy for Pre-Operative Anxiety

Overseen By Brittany Norton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jacques E. Chelly

Must not be taking: Opioids

Disqualifiers: Opioid dependence, Chronic pain, Fibromyalgia, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

60 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 4 6 7}

How 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. ^{1 4 5 8 9}

Research Team

Jacques E Chelly, MD

Principal Investigator

University of Pittsburgh

Eligibility 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

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).

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

Treatment Details

Interventions

• Auriculotherapy cryopuncture device with nitrogen gas
• Auriculotherapy cryopuncture device without nitrogen gas

Trial Overview 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.

Participant Groups

Group I: Auriculotherapy cryopuncture device with nitrogen gas Active Control 1 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 gas Placebo Group 1 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.

Who Is Running the Clinical Trial?

Jacques E. Chelly

Lead Sponsor

Trials

10

Recruited

710+

Findings from Research

Auricular acupuncture and extended auricular therapy can effectively help with pain and anxiety, but using embedded needles poses significant safety risks, including infections and chondritis, as highlighted by 19 adverse event case reports and multiple safety reviews.

Extended auricular therapy using non-invasive methods, like applying natural seeds, offers similar clinical benefits without the risks associated with embedded needles, suggesting a need for further research to determine the necessity of needle use in auricular treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Nielsen, A., Gereau, S., Tick, H.[2021]

A study involving 182 patients found that auricular acupuncture significantly reduced state anxiety before dental treatment, lowering anxiety scores from 54.7 to 46.9, compared to a smaller reduction in the sham acupuncture group.

Unlike the control group, which experienced an increase in anxiety, the results suggest that auricular acupuncture is an effective and minimally invasive option for patients seeking relief from anxiety related to dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. Michalek-Sauberer, A., Gusenleitner, E., Gleiss, A., et al.[2021]

This systematic review aims to evaluate the effectiveness of auriculotherapy as a treatment for chemotherapy-induced nausea and vomiting (CINV) in cancer patients, focusing on randomized controlled trials comparing it to sham treatments and standard antiemetic drugs.

The review will assess outcomes related to nausea and vomiting during different stages of chemotherapy, using rigorous methods to ensure quality and reliability of the evidence, which could highlight auriculotherapy as a safe and cost-effective antiemetic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auriculotherapy to control chemotherapy-induced nausea and vomiting in patients with cancer: protocol of a systematic review. Melo, RNR., Francisco, SC., Moura, CC., et al.[2023]

Auricular acupuncture (AA) significantly reduced preoperative anxiety in female patients scheduled for surgery, as measured by the State-Trait-Anxiety Inventory, while anxiety levels in the control group increased.

The study demonstrated that AA is an acceptable and feasible treatment for preoperative anxiety, providing a basis for a larger randomized controlled trial to further investigate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for treatment of preoperative anxiety in patients scheduled for ambulatory gynaecological surgery: a prospective controlled investigation with a non-randomised arm. Wunsch, JK., Klausenitz, C., Janner, H., et al.[2019]

Auricular therapy, which includes techniques like acupuncture and acupressure, has been used for over 2500 years, but its modern application as auricular acupuncture (AA) has gained recognition since 1957 due to its connection to the autonomic nervous system and other biological factors.

AA has shown potential in treating various conditions such as pain, anxiety, and obesity, but more research is needed to fully understand its mechanisms and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Hou, PW., Hsu, HC., Lin, YW., et al.[2023]

Auricular acupuncture (AA) is generally safe, but this case report highlights a rare occurrence where an Aiguille Semi-Permanente® (ASP®) needle was found retained in a patient's external auditory canal after treatment for complex regional pain syndrome.

Acupuncturists should be vigilant for potential complications, such as a foreign-body sensation in the ear, and conduct examinations if patients report unusual symptoms following AA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. Kazal, LA.[2023]

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., et al.[2022]

A study involving 35 elective surgery patients found that both body acupuncture and auricular acupuncture significantly reduced preoperative anxiety, as measured by the Zung Self-Rating Anxiety Scale.

The body acupuncture group showed a decrease in anxiety scores from 55.39 to 44.82, while the auricular acupuncture group decreased from 57.57 to 46.32, indicating that both methods are effective interventions for managing preoperative anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the treatment effectiveness of body acupuncture and auricular acupuncture in preoperative anxiety treatment. Wu, S., Liang, J., Zhu, X., et al.[2021]

In a pilot trial with 26 university students, auriculotherapy significantly reduced anxiety levels as measured by the State-Trait-Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) before exams, indicating its efficacy in managing pre-exam anxiety.

The treatment was found to be safe, with minimal discomfort reported by only one participant, and it also improved sleep quality and reduced cortisol levels, suggesting a beneficial impact on overall stress response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Auriculotherapy on Situational Anxiety Trigged by Examinations: A Randomized Pilot Trial. Vieira, A., Sousa, P., Moura, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Auriculotherapy to control chemotherapy-induced nausea and vomiting in patients with cancer: protocol of a systematic review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for treatment of preoperative anxiety in patients scheduled for ambulatory gynaecological surgery: a prospective controlled investigation with a non-randomised arm. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Comparing the treatment effectiveness of body acupuncture and auricular acupuncture in preoperative anxiety treatment. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Auriculotherapy on Situational Anxiety Trigged by Examinations: A Randomized Pilot Trial. [2022]