Ear Acupuncture for Pain and Anxiety Management in Early Labor

NCT06678893 | Completed FDA Device

• 1 other identifier: 2145161-3
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Anxiety; Labor

Keywords

Acupuncture; Auricular Acupuncture; Early labor; Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  up to 3 months

Secondary Outcomes (2)

• Visual Analogue Scale pain score

  30 minutes

• Visual Analogue Scale Anxiety Scores

  30 min

Study Arms (2)

Auricular Acupunture

EXPERIMENTAL

Participants randomized to this arm will undergo treatment with the 5 Needle Protocol of Auricular Acupuncture

Device: Acupuncture Needle on an adhesive

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will undergo treatment with small adhesives without needles placed in the same configuration as the 5 Needle Protocol

Device: Adhesives

Interventions

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.

Auricular Acupunture

Adhesives DEVICE

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (7)

• Levett KM, Smith CA, Dahlen HG, Bensoussan A. Acupuncture and acupressure for pain management in labour and birth: a critical narrative review of current systematic review evidence. Complement Ther Med. 2014 Jun;22(3):523-40. doi: 10.1016/j.ctim.2014.03.011. Epub 2014 Apr 13.

  PMID: 24906592 BACKGROUND

• Baumler P, Zhang W, Stubinger T, Irnich D. Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. BMJ Open. 2021 Sep 6;11(9):e045961. doi: 10.1136/bmjopen-2020-045961.

  PMID: 34489268 BACKGROUND

• Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.

  PMID: 24138333 BACKGROUND

• Vakilian K, Ghaemmaghami M, Sheikhganbari N, Shabani F, Vahedi M. Reducing Labor Anxiety with Auriculotherapy: A Randomized Clinical Trial Study. Chin J Integr Med. 2022 May;28(5):440-444. doi: 10.1007/s11655-021-3452-0. Epub 2021 Sep 28.

  PMID: 34581941 BACKGROUND

• Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.

  PMID: 32032444 BACKGROUND

• King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. Mil Med. 2013 Aug;178(8):867-74. doi: 10.7205/MILMED-D-13-00075.

  PMID: 23929047 BACKGROUND

• Thomson G, Feeley C, Moran VH, Downe S, Oladapo OT. Women's experiences of pharmacological and non-pharmacological pain relief methods for labour and childbirth: a qualitative systematic review. Reprod Health. 2019 May 30;16(1):71. doi: 10.1186/s12978-019-0735-4.

  PMID: 31146759 BACKGROUND

Related Links

• This is the website for the People's Organization of Community Acupuncture, this is the organization through which the key study personnel were trained in auricular acupuncture
• Providence Community Acupuncture is the local organization that hosted the training and education for our key study personnel to learn auricular acupuncture

MeSH Terms

Conditions

Pain; Anxiety Disorders; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident Physician

Model Details: This is a pilot study of a randomized control trial. Consented participants will be randomized to either auricular acupuncture or placebo intervention. Blood pressure, heart rate, and VAS pain and anxiety scores will be recorded and compared pre and post intervention in both treatment arms.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 7, 2024
• Study Start: November 5, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)