Battlefield Auricular Acupuncture for Control of Post-partum Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of Subjects Who Achieved 50% Sustained Pain Reduction
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
- •Post-partum female (DoD beneficiaries).
- •Age 18 years or older
- •Pain score rating post-delivery of greater or equal to 4/10.
排除标准
- •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
结局指标
主要结局
Number of Subjects Who Achieved 50% Sustained Pain Reduction
时间窗: 12 days
measured daily from days 0-11.
次要结局
- Morphine Equivalent Use(12 days)
