Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03525860|
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-Operative Atrial Fibrillation Acupuncture Therapy||Procedure: Acupuncture||Not Applicable|
Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias.
• 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Feasibility of Acupuncture Treatment in the Post-Operative Cardio-Thoracic Setting for Arrhythmias in Patients Undergoing Open Heart Surgery- A Pilot Study|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
Experimental: 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).
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: 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).
- Acupuncture treatment in the hospital setting [ Time Frame: 3 days post surgery ]The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.
- Number of patients with recurrent atrial fibrillation [ Time Frame: 3 consecutive days post-surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525860
|Contact: Heather Ondler Hinson, CRCfirstname.lastname@example.org|
|Contact: Molly Mallory, L.Ac.||email@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Chaim Leker Locker, M.D.||Mayo Clinic|