Battlefield Auricular Acupuncture for Control of Post-partum Pain
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/29/2018 |
| Start Date: | February 2016 |
| End Date: | May 20, 2018 |
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.
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.
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.
- 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.
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE
IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
- 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
We found this trial at
1
site
4700 North Las Vegas Boulevard
Nellis Air Force Base, Nevada 89191
Nellis Air Force Base, Nevada 89191
Principal Investigator: Michael J Kim, MD
Phone: 702-653-3298
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