Auricular Acupressure for Lung Surgery Prehabilitation

Overseen By Maria Lucia Madariaga, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Allergy to Vaccaria seeds, Ear conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether auricular acupressure (a therapy using pressure points on the ear) can help prepare individuals for lung surgery. The aim is to determine if this therapy can enhance appetite, energy, mood, and sleep while reducing anxiety and pain before major lung surgery. Participants will be divided into two groups: one receiving the actual treatment and another receiving a sham (fake) version for comparison. Eligible participants must have lung surgery scheduled at least two weeks away and require an adult care partner to assist with the procedure. As an unphased trial, this study provides a unique opportunity to explore a potentially beneficial therapy before surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that auricular acupressure is safe for lung surgery prehabilitation?

Research shows that auricular acupressure is generally safe. Most individuals experience only minor side effects, such as skin irritation at the application site. Studies have found it can help with anxiety and depression without causing serious issues, making it a well-tolerated option for many. Prospective trial participants can find reassurance in the treatment's history of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular acupressure for lung surgery prehabilitation because it offers a drug-free, non-invasive approach to managing symptoms such as anxiety, stress, and pain, which are common in surgical patients. Unlike traditional treatments that might rely on medications with potential side effects, auricular acupressure uses small seeds placed on specific points of the ear to potentially promote healing and balance in the body. This technique targets areas believed to influence emotional and physical well-being, aiming to enhance recovery and improve overall surgical outcomes.

What evidence suggests that auricular acupressure is effective for lung surgery prehabilitation?

Research has shown that ear acupressure, which participants in the experimental group of this trial will receive, can significantly aid in pain relief. For individuals experiencing post-surgical pain, it is 25% more effective than other methods. Studies also indicate that it can help manage pain and disability in those with long-term conditions. Additionally, ear acupressure might enhance exercise ability and reduce fatigue in lung cancer patients. These findings suggest it could be very useful in preparing for lung surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Maria Lucia Madariaga, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals preparing for major lung surgery who may be experiencing frailty. It's designed to help improve their overall condition before the operation, potentially enhancing recovery outcomes.

Inclusion Criteria

I have an adult who can help me with my treatment.

Able to understand English at a 4th grade level

Able to provide informed consent for participation

Exclusion Criteria

I do not have skin conditions like eczema, frostbite, or sunburn on my ears.

Allergy to Vaccaria seeds

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo auricular acupressure to enhance prehabilitation benefits before thoracic surgery

2-4 weeks

Weekly visits for seed placement verification

Follow-up

Participants are monitored for safety and effectiveness after prehabilitation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Acupressure

Trial Overview The study is testing auricular acupressure, a type of complementary medicine similar to acupuncture but focused on the ear, to see if it can benefit patients by increasing energy and reducing pain or anxiety before lung surgery.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group. o Intervention group seed points: 1. Shen Men (anxiety, depression, stress, pain) 2. Point 0 (homeostasis, energy, mood) 3. Endocrine (hormonal homeostasis) 4. Subcortex (insomnia, anxiety, pain, inflammation) 5. Autonomic (autonomic balance, pain)

Group II: Control Group Placebo Group 1 Intervention

A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group. o Control group sham seed points: 1. Inside edge, center of tragus 2. Helix midway between apex and tubercle 3. Helix 1 cm anterior to apex 4. 5 mm anterior to Shen Men 5. Covered, 5 mm anterior and superior to endocrine For the sham intervention (Sham Type II, same intervention with seeding and intermittent pressing) the seeds are placed at nonacupressure points for the control group.

Auricular Acupressure is already approved in United States, China for the following indications:

Approved in United States as Auricular Acupressure for:

• Pain management
• Fatigue
• Insomnia
• Nausea and vomiting
• Depression
• Quality of life improvement

Approved in China as Auriculotherapy for:

• Weight loss
• Obesity management
• Appetite regulation

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

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]

This systematic review aims to evaluate the efficacy and safety of auricular acupuncture (AA) in reducing preoperative anxiety by analyzing existing randomized controlled trials, which suggests that AA could be a beneficial intervention for patients before surgery.

The review will compare AA to other acupuncture methods, pharmacological treatments, and no treatment, using standardized questionnaires to measure anxiety and fear, ensuring a comprehensive assessment of its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupuncture for Preoperative Anxiety-Protocol of Systematic Review and Meta-Analysis of Randomized Controlled Trials. Dietzel, J., Cummings, M., Hua, K., et al.[2020]

Auricular acupressure is a non-invasive and easy-to-learn therapy based on traditional Chinese medicine, showing promise as an alternative or complementary approach for symptom management with minimal side effects.

There is growing evidence supporting the effectiveness of auricular acupressure, particularly in Taiwan, highlighting the need for nursing education to incorporate this therapy into evidence-based practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Usage of Auricular Acupressure in Clinical Nursing and Evidence-Based Research]. Cheng, JF., Lo, C., Tzeng, YL.[2018]

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 review of 23 studies on auricular acupuncture for postoperative pain found that 9 met the criteria for inclusion, with 8 showing that auricular acupuncture was more effective than control conditions.

While the evidence suggests that auricular acupuncture can help reduce postoperative pain, the overall findings are not strong enough to be considered definitive, as the studies varied widely in quality and results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for postoperative pain control: a systematic review of randomised clinical trials. Usichenko, TI., Lehmann, Ch., Ernst, E.[2018]

In a study involving 120 patients undergoing total hip arthroplasty, those receiving auricular acupuncture (AA) required 15% less fentanyl for pain management during surgery compared to a sham group, indicating a potential analgesic effect of AA.

The study suggests that while AA may provide modest pain relief, further research is needed to fully understand its effectiveness as a complementary analgesic method in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. Wetzel, B., Pavlovic, D., Kuse, R., et al.[2022]

Auricular acupuncture (AA) significantly reduced symptoms of sleep disorders in patients aged 20 to 45, as evidenced by a statistically significant difference in scores after 8 weeks of treatment (P = .014).

While AA showed some relief in anxiety and TMD pain symptoms, these results were not statistically significant, indicating that AA may be more effective for sleep disorders than for anxiety or TMD pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Auricular Acupuncture on the Reduction of Symptoms Related to Sleep Disorders, Anxiety and Temporomandibular Disorder (TMD). Cândido Dos Reis, A., Theodoro de Oliveira, T., Vidal, CL., et al.[2022]

Auricular acupressure significantly improves sleep quality in lung cancer patients, as shown by a meta-analysis of 9 studies involving 802 patients, with a notable reduction in sleep disturbance and medication usage.

The analysis revealed a strong effect size for sleep improvement (standard mean difference of -0.80) and a significant reduction in the rate of sleep disturbances and reliance on sleep medications, indicating both efficacy and safety of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupressure for Improving Sleep Quality in Patients With Lung Cancer: A Systematic Review and Meta-analysis. Lu, HB., Ma, RC., Yin, YY., et al.[2022]

Auricular stimulation (AS) significantly reduces preoperative anxiety scores compared to sham controls and no intervention, based on a systematic review of 15 studies involving 1603 patients, indicating its potential effectiveness in managing anxiety before surgery.

There were no serious adverse effects reported from AS, suggesting it is a safe option; however, its efficacy is comparable to benzodiazepines, and further research is needed to confirm its benefits due to varying levels of evidence quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular stimulation for preoperative anxiety - A systematic review and meta-analysis of randomized controlled clinical trials. Usichenko, TI., Hua, K., Cummings, M., et al.[2022]

Auricular acupressure (AA) significantly improves pain relief in patients with acute postoperative pain, showing a 25% higher effective rate compared to conventional therapy across 26 studies involving 1,682 participants.

The most notable pain relief from AA was observed at 72 hours post-surgery and particularly in patients undergoing abdominal surgery, with no serious adverse effects reported, suggesting it is a safe adjunct treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Auricular Acupressure for Acute Postoperative Pain after Surgery: A Systematic Review and Meta-Analysis. Zhong, Q., Wang, D., Bai, YM., et al.[2020]

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]

Citations

1. withpower.com withpower.com/trial/phase-frailty-7-2024-f01e8

Auricular Acupressure for Lung Surgery Prehabilitation Auricular acupressure (AA) significantly improves pain relief in patients with acute postoperative pain, showing a 25% higher effective rate compared to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12268779/

Efficacy and safety of combined Baduanjin-auricular ... Therefore, in this study, we aim to assess the efficacy of the combined intervention of Baduanjin and auricular acupressure as an alternative regimen for ...

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1349975/full

Effectiveness of acupuncture combined with auricular ... The aim of this study protocol is to observe the effectiveness of acupuncture combined with auricular acupressure in decreasing the incidence and related ...

4. liebertpub.com liebertpub.com/doi/full/10.1089/jicm.2023.0630

The Effectiveness of Auricular Acupressure on Chronic ... Objectives: To assess the effectiveness of auricular acupressure (AA) in managing pain and disability in individuals with chronic ...

5. researchgate.net researchgate.net/publication/393087786_Efficacy_and_safety_of_combined_Baduanjin-auricular_acupressure_treatment_for_the_postoperative_rehabilitation_of_patients_with_non-small_cell_lung_cancer_protocol_for_a_randomized_controlled_trial

(PDF) Efficacy and safety of combined Baduanjin-auricular ... Baduanjin or auricular acupuncture can significantly improve exercise tolerance, fatigue, and QOL in patients with lung cancer. Baduanjin ...

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.921054/full

Efficacy and safety of acupuncture combined with auricular ... This study will provide rigorous clinical evidence evaluating the efficacy and safety of using A&AA as a smoking cessation therapy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9760812/

Effects and safety of auricular acupressure on depression and ... Auricular acupressure is an effective and safe treatment for alleviating symptoms of depressive and anxiety in patients with COVID-19.