N/A
N=70
Battlefield Auricular Acupuncture for Control of Post-partum Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02526186 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Subjects Who Achieved 50% Sustained Pain Reduction — 0; 0; 2; 6 # of subjects with 50% pain reduction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Battlefield Auricular Acupuncture (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mike O'Callaghan Military Hospital
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Achieved 50% Sustained Pain Reduction |
0; 0; 2; 6; 3; 9 | — |
| SECONDARY Morphine Equivalent Use |
88; 82 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02526186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.