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RecruitingNCT06516198Updated Dec 9, 2025

Auricular Acupressure in Prehabilitation

An interventional study of Auricular Acupressure in Frailty, Thoracic and Prehabilitation, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by University of Chicago · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

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

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Keywords

  • accupressure
  • vaccaria seeds
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 681 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Allergy to Vaccaria seeds
  • Medical condition affecting either ear preventing use of auricular acupressure such as eczema, frostbite, sunburn
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    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)

    Other: Auricular Acupressure

  • Sham comparator
    Control Group

    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.

    Other: Auricular Acupressure

Interventions

  • OtherAuricular Acupressure

    Seeds will be placed during the clinic visit by the acupuncturist or the research associate according to the group the patient was assigned to. The care partner will observe the placement. A photograph of the seed placement will be taken and given to the care partner and to the patient after the relevant points are labeled by number or letter. The method of pressing is demonstrated for 1 one of the seeds, the care partner practices pressing on 2 other seeds, and the patient practices pressing on the remaining 2 seeds. Pressing consists of applying pressure, gradually increasing the pressure until the patient expresses discomfort, and maintaining that pressure until 2 minutes have passed. After pressing has been performed for each seed, the seeds are removed in clinic prior to clinic discharge.

06

What researchers measure

Primary outcomes

  1. Number of patients enrolled

    The patient will complete a form after each seed pressing confirming the pressing and the time.

    Time frame: 2 weeks

Secondary outcomes

  1. Ease of participation in the study.

    The patient will complete a form after each seed pressing confirming the pressing and the time.

    Time frame: End of Study (Week 4)

Other outcomes

  1. Accuracy of seed placement by a non-professional care partner.

    The care partner will place the seeds and then send a photo to the research team for correct seed placement verification or correction on a weekly basis. Accuracy of seed placement will be assessed by determining the number of corrections required to achieve seed placement each week.

    Time frame: Weekly until Week 4

  2. The change of the intervention prehabilitation results

    Compared to the control group, the intervention will demonstrate better increases in endurance, function, mood, breathing capacity, and strength.

    Time frame: End of Study (Week 4)

07

Study locations

1 of 1 sites recruiting
  • University of Chicago
    Chicago, Illinois 60637, United States
    Recruiting
08

References and documents

Publications

  • Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19. PubMed 24138333 ↗
  • Ferguson MK, Watson S, Johnson E, Vigneswaran WT. Predicted postoperative lung function is associated with all-cause long-term mortality after major lung resection for cancer. Eur J Cardiothorac Surg. 2014 Apr;45(4):660-4. doi: 10.1093/ejcts/ezt462. Epub 2013 Sep 19. PubMed 24052607 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06516198
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Jul 23, 2024
Start date
Jul 21, 2025
Primary completion
Jun 20, 2027 (estimated)
Completion
Jun 20, 2027 (estimated)
Last update
Dec 9, 2025

Study contacts

Maria Lucia Madariaga, MD
Contact
mlmadariaga@bsd.uchicago.edu
7737022500
Maria Lucia Madariaga, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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