Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting

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Mayo Clinic

Status

Completed

Conditions

Post-Operative Atrial Fibrillation
Acupuncture Therapy

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03525860
17-006095

Details and patient eligibility

About

A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients who have undergone open heart surgery procedures. The acupuncture treatments may begin as early as postoperative Day 2.

Full description

Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias. 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients who have undergone CABG and/or cardiac valve operations.
  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

  1. Patients with any other cardiac or non-cardiac concomitant procedures.
  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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

Acupuncture Treatment
Experimental group
Description:
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).
Treatment:
Procedure: Acupuncture
No Intervention
No Intervention group
Description:
20 subjects will be treated with standard of care only. Will complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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