This is a study evaluating the feasibility and acceptability of ear acupuncture for the management of pain and anxiety in early labor.
This double blinded randomized controlled pilot study will take place in the Emergency Department of Women and Infants Hospital (WIH) in Providence Rhode Island. This study seeks to assess feasibility and acceptability utilizing the 5 Needle Protocol of Auricular Acupuncture (5NP, AA) during early labor for management of pain and anxiety. At the time of emergency department evaluation at Women and Infants Hospital for a chief complaint of painful contractions, the investigators will enroll 40 pregnant people as a feasibility sample investigating the impact of auricular acupuncture (AA) on patient-reported pain and anxiety in early labor. Participants will be randomized to either AA using the 5 Needle protocol versus placebo acupuncture. While the data on the efficacy of auricular acupuncture for pain and anxiety is mounting, evidence for utility in treating labor pain is limited. This proposal will be one of the first to randomize pregnant people presenting with concern for pain or anxiety related to labor contractions to this potential treatment. The investigator's long-term goal is to find an effective treatment option for a common labor complaint while improving satisfaction with pain management in the Emergency Department. Given this is a pilot study, the primary objective is to determine feasibility of implementing a randomized control trial evaluating the effect of auricular acupuncture as an initial treatment for improving perceived pain and anxiety symptoms related to contractions. The central hypothesis is that this is indeed feasible and acceptable in the Emergency Department setting of Women and Infants Hospital in Rhode Island. The secondary objective is to assess the trend that auricular acupuncture has on pain and anxiety scores, as well as on heart rate and blood pressure. Though the sample size is aimed to assess feasibility and will not be sufficiently powered for an efficacy analysis, if trends suggest that auricular acupuncture decreases pain and/or anxiety sores, further investigation with a larger randomized control trial will be warranted. Eligible participants for this trial include Spanish or English speaking patients 18 years or older who are in early labor with a singleton pregnancy greater than or equal to 37+0 weeks gestation, and willing to be randomized to receive auricular acupuncture versus placebo. Early labor will be defined as less than 6 centimeters dilated and experiencing at least 2 contractions in ten minutes, per patient report and/or tocometry. Exclusion criteria include patients less than 18 years of age, non-Spanish or English-speaking patients, multi-gestation, preterm labor, greater than or equal to 6 cm dilated, less than 2 contractions in 10 minutes, morphine or nitrous oxide administration within the last two hours, congenital anomalies, open wounds or skin disorders of the ear, previous adverse reactions to acupuncture and/or allergies or contraindications to adhesives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
This study utilizes acupuncture needs on small adhesives which will be placed according to the 5NP NADA Auricular Acupuncture Protocol.
For those randomized to the placebo arm, adhesives without needles will be placed according to the 5NP NADA Auricular Acupuncture Protocol placement
Women and Infants Hospital
Providence, Rhode Island, United States
Percent of eligible participants that consent to being a part of the study
The investigators are evaluating if doing a randomized control trial on acupuncture in early labor is feasible in the setting of the Emergency Department of Women and Infants Hospital in Rhode Island by evaluating how many eligible patients consent to being a part of the study
Time frame: up to 3 months
Likert scale 1 to 5 of patient satisfaction with treatment experience
We are evaluating if doing acupuncture during labor is acceptable to patients in the emergency department of Women and Infants Hospital by using a Likert scale questionnaire evaluating their experience of receiving the intervention and their likelihood of doing the intervention were it to be offered again. The lowest value of the scale is 1 and the highest is 5. A higher number indicates higher level of satisfaction with the intervention performed.
Time frame: up to 3 months
Visual Analogue Scale pain score
The investigators are comparing visual analogue scale pain scores pre and post acupuncture versus placebo intervention to see if there is a reduction in pain score that correlates with our intervention. This study is not powered to prove causality but we will look for correlation as a secondary outcome. The minimum value on the scale is 0 and the maximum is 10. A higher number indicates higher levels of pain.
Time frame: 30 minutes
Visual Analogue Scale Anxiety Scores
The investigators will be evaluating visual analogue scale Anxiety scores pre and post intervention of placebo versus acupuncture to see if there is a reduction in anxiety that correlates with our intervention. This study is not powered to prove causality however will look for correlation as a secondary outcome. The minimum value on the scale is 0 and the maximum is 10. A higher number indicates higher levels of anxiety.
Time frame: 30 min
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