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Completed

NCT Number: NCT06678893

Ear Acupuncture for Pain and Anxiety Management in Early Labor

This is a study evaluating the feasibility and acceptability of ear acupuncture for the management of pain and anxiety in early labor.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older, Spanish or English speaking, with term (37+ weeks pregnant) singleton pregnancy, in early labor (as defined as less than 6cm dilated and having at least 2 contractions in 10 minutes)

Exclusion criteria

  • Younger than 18 years old, non-english or spanish speaking, greater than 6cm or not having consistent contractions (less than 2 contractions in 10 minutes), preterm and/or multiple gestation pregnancy, received morphine or nitrous oxide within the last 2 hours, congenital anomalies/wound/skin disorders of the ear, or prior adverse reaction to acupuncture, adverse reactions or allergies to adhesives.

Treatment and study plan

Acupuncture Needle on an adhesive

Device

This study utilizes acupuncture needs on small adhesives which will be placed according to the 5NP NADA Auricular Acupuncture Protocol.

Adhesives

Device

For those randomized to the placebo arm, adhesives without needles will be placed according to the 5NP NADA Auricular Acupuncture Protocol placement

Primary outcomes

  1. Percent of eligible participants that consent to being a part of the study

    Time frame: up to 3 months

    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

  2. Likert scale 1 to 5 of patient satisfaction with treatment experience

    Time frame: up to 3 months

    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.

Secondary outcomes

  1. Visual Analogue Scale pain score

    Time frame: 30 minutes

    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.

  2. Visual Analogue Scale Anxiety Scores

    Time frame: 30 min

    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.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

Pilor Trial of Auricular Acupuncture for Latent Labor-Related Pain and Anxiety

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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