Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
NCT ID: NCT03525860
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2018-07-26
2019-08-26
Brief Summary
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Detailed Description
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Secondary Aims
• Evaluate the short-term effect of acupuncture including the effects on patient's arrhythmias, stress, anxiety, and pain measured by Electrocardiogram monitoring and Electrocardiography, VAS scores, and WIWI questionnaire for the patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acupuncture Treatment
20 subjects will be treated with standard of care and acupuncture.
Will complete Symptom and Pain questionnaire (VAS) and a Was It Worth It (WIWI) questionnaire each day of study participation (3 days).
Acupuncture
The subject is placed in the selected position (lying down or sitting), based on their comfort level. The areas to be needled are prepped with an alcohol swab. Mandatory standards and safety guidelines for acupuncture will be followed.
The acupuncture treatment protocol will be based on Traditional Chinese Medicine (TCM) theory. The TCM treatment strategy is designed to Benefit the Heart, Tonify Heart Qi and Blood, Calm and Sedate Cardiac Excitability and Regulate the Qi. Current literature supports the use of selected acupuncture points as possibly beneficial in regulating the autonomic nervous system, modulating Heart Rate Variability (HRV), relieving chest pain, and reducing arrhythmias.
11 sterile, single use, disposable needles will be placed one by one until all needles are in place.
Needles remain in place for additional 20 minutes or so as the patient remains in the selected position
.
No Intervention
20 subjects will be treated with standard of care only.
Will complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).
No interventions assigned to this group
Interventions
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Acupuncture
The subject is placed in the selected position (lying down or sitting), based on their comfort level. The areas to be needled are prepped with an alcohol swab. Mandatory standards and safety guidelines for acupuncture will be followed.
The acupuncture treatment protocol will be based on Traditional Chinese Medicine (TCM) theory. The TCM treatment strategy is designed to Benefit the Heart, Tonify Heart Qi and Blood, Calm and Sedate Cardiac Excitability and Regulate the Qi. Current literature supports the use of selected acupuncture points as possibly beneficial in regulating the autonomic nervous system, modulating Heart Rate Variability (HRV), relieving chest pain, and reducing arrhythmias.
11 sterile, single use, disposable needles will be placed one by one until all needles are in place.
Needles remain in place for additional 20 minutes or so as the patient remains in the selected position
.
Eligibility Criteria
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Inclusion Criteria
2. Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.
3. Patients moving to the step-down unit on postoperative day 2 or later.
4. Ability to provide informed consent.
5. Ability to speak English and complete all aspects of this trial.
6. At least 18 years of age.
Exclusion Criteria
2. Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.
3. Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.
4. Patients with platelet count \<50,000
5. Patients in a severe immunocompromised state.
6. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Chaim Leker Locker, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-006095
Identifier Type: -
Identifier Source: org_study_id