Battlefield Auricular Acupuncture for Control of Post-partum Pain

NCT ID: NCT02526186

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-05-20

Brief Summary

We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Post-partum patients (DoD beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth in a hospital setting will be offered the opportunity to participate in the study through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24 hours post caesarean section subjects will be given treatment according to their randomization group. Subjects will be assessed on pain control, overall satisfaction with pain management, and the amount of pharmacological pain medications used. Safety of measures will also be assessed to include infection rates, syncope, vertigo, and hypotension.

Detailed Description

Screening Visit:

• Obtain signed Informed Consent document and HIPAA Authorization.
• Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria and including previous encounter, vital signs review, medication list, co-morbidities, demographics, problems list, prior obstetric history, and note any prior acupuncture received.
• Record: Date of birth, age, gender, race, ethnicity, last 4 of social security number, current email address.

Randomization: Subjects will then be randomized into one of two groups by one of the Research Coordinators using a random number generator:

• Group 1: Standard of care only.
• Group 2: Standard of care plus Battlefield acupuncture at treatment sites Cingulate gyrus, thalamus, omega 2, shen-men, point zero in both ears (see figures 1-5). The 5 needles will remain in each ear for up to 7 days or allowed to fall out on their own (the patient will be instructed not to remove the needles).
• Subject's ears will be cleansed with an alcohol swab
• Subjects will be given a handout of standard BFA Discharge Instructions including what an infection looks like and what to do in the event of an infection (see attached).

Visit 1: Will occur after a minimum of 6 hours post vaginal birth (up until hospital discharge) to avoid disturbing maternal infant bonding or a minimum of 24 hours post caesarean section to avoid confounding with the anesthesia:

• Subject will be given treatment according to their randomization group.
• All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 6 hours.
• Satisfaction with post-partum pain management will be assessed with the following questions:
• On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0 - 10 very satisfied)
• Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
• On a scale of 0-10, with 10 being the worst pain, what is your level of pain?

In hospital data collection: Data will be collected each day until the patient has been discharged from the hospital. Subjects will be contacted either in person or via phone and the hospital stay will vary from patient to patient:

• We will review the subject's medical record and record RN Recorded Pain assessments, Delivery method (either Caesarean section or spontaneous vaginal delivery), Delivery complications (vaginal lacerations, use of episiotomy, operative vaginal delivery, shoulder dystocia, post-partum hemorrhage), Birth weight, Maternal Parity, and record what pain medications they are taking.
• We will ask subjects if they prefer to be contacted in-person or via telephone while in the hospital.
• Satisfaction with post-partum pain management will be assessed with the following questions:
• On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0 - 10 very satisfied)
• Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
• On a scale of 0-10, with 10 being the worst pain, what is your level of pain?
• Are the needles still in place? If yes, how many in each ear?

Post hospital discharge: Each day up until 10 days post Visit 1. Subjects will be contacted phone and the following information will be collected:

• Satisfaction with post-partum pain management will be assessed with the following questions:
• On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0-10 very satisfied)
• Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
• On a scale of 0-10, with 10 being the worst pain, what is your level of pain? • We will record what pain medications they are taking including drug name, strength, and total doses since discharge from the hospital.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Standard of Care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Battlefield Auricular Acupuncture

Standard of Care plus Battlefield Auricular Acupuncture

Group Type: EXPERIMENTAL

Battlefield Auricular Acupuncture

Intervention Type: DEVICE

Interventions

Battlefield Auricular Acupuncture

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Post-partum female (DoD beneficiaries).
• Age 18 years or older
• Pain score rating post-delivery of greater or equal to 4/10.

Exclusion:

• Absence of one or more ears
• Active cellulitis of ear
• Ear anatomy precluding identification of acupuncture landmarks
• Non-English speaking
• Use of Hearing Aids that preclude the use of ear acupuncture
• Known allergy to gold

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Medical Center

Locations

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, United States

Countries

United States

References

Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.

Reference Type: DERIVED

PMID: 33078388 (View on PubMed)

Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

Reference Type: DERIVED

PMID: 32871021 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FWH20150072H

Identifier Type: -

Identifier Source: org_study_id