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Behavioural Intervention
Auricular Acupressure for Lung Surgery Prehabilitation
N/A
Recruiting
Led By Maria Lucia Madariaga, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 50 years
Being considered for major lung surgery
Must not have
Medical condition affecting either ear preventing use of auricular acupressure such as eczema, frostbite, sunburn
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly until week 4
Summary
This trial shows that complementary medicine, like acupuncture, can help with improving appetite, energy levels, reducing anxiety and pain, and enhancing sleep. Acupuncture is a popular form of complementary medicine in the US
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Auricular acupressure is generally considered safe with minimal side effects. Some participants might experience slight discomfort at the pressure points or minor bruising.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I am being considered for a major lung surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have skin conditions like eczema, frostbite, or sunburn on my ears.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly until week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly until week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients enrolled
Secondary study objectives
Ease of participation in the study.
Other study objectives
Accuracy of seed placement by a non-professional care partner.
The change of the intervention prehabilitation results
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental GroupExperimental Treatment1 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 GroupPlacebo Group1 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.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
759,034 Total Patients Enrolled
Maria Lucia Madariaga, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
10 Total Patients Enrolled
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