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Auricular Acupressure in Prehabilitation

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The University of Chicago

Status

Enrolling

Conditions

Lung Surgery
Wedge Resection
Pneumonectomy; Status
Thoracic
Lobectomy
Frailty
Prehabilitation
Segmentectomy

Treatments

Other: Auricular Acupressure

Study type

Interventional

Funder types

Other

Identifiers

NCT06516198
IRB24-0888

Details and patient eligibility

About

Complementary medicine is recognized for its ability to enhance appetite, increase energy, reduce anxiety, decrease pain, and improve sleep, among many other benefits. Acupuncture is among the most frequent types of complementary medicine practiced in the US, and Medicare currently includes back pain as a reimbursable indication for this therapy. Acupuncture-related therapies may enhance efforts at prehabilitation in candidates for major lung resection.

Full description

The plan is to use a small number of points for auricular acupressure that are selected to improve overall health, both physical and mental. Auricular acupuncture for management of pain using 5 points, informally referred to as "battlefield acupuncture" has demonstrated significant improvement in acute and chronic pain management. Auricular acupressure using a similarly small number of points has demonstrated improvement in chemotherapy-related disturbed sleep, fatigue, and appetite, postpartum depression and fatigue, and chemotherapy related fatigue and depression. It appears that auricular acupressure may be suitable for enhancing prehabilitation interventions for preoperative patients.

Patients will be selected from among individuals being considered for major lung surgery (wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy; open or minimally invasive) who are expected to pursue a period of prehabilitation of 2 or more weeks prior to surgery.

Enrollment

40 estimated patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Being considered for major lung surgery
  • Surgery is not scheduled for at least 2 weeks
  • Age ≥ 50 years
  • Able to understand English at a 4th grade level
  • No known contraindications to prehabilitation (strength, endurance, balance exercises)
  • Able to provide informed consent for participation
  • Has an adult care partner who will be available and capable of placing seeds
  • Has access to smart phone for communication and image sharing
  • Underwent frailty screening (given any score)
  • Able to perform spirometry testing in clinic

Exclusion Criteria:

  • Allergy to Vaccaria seeds
  • Medical condition affecting either ear preventing use of auricular acupressure such as eczema, frostbite, sunburn

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Experimental Group
Experimental group
Description:
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)
Treatment:
Other: Auricular Acupressure
Control Group
Sham Comparator group
Description:
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.
Treatment:
Other: Auricular Acupressure

Trial contacts and locations

1

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Central trial contact

Maria Lucia Madariaga, MD

Data sourced from clinicaltrials.gov

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