Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

September 7, 2022 updated by: Lena B Martensson, University of Skövde

A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain

The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Skövde, Sweden, SE-541 28
        • School of Life Sciences, University of Skövde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Admission to the labour ward in spontaneous onset of labour
  • Latent or active phase of labour
  • Nulliparity
  • Singleton pregnancy, cephalic presentation
  • Gestation: 37+0 to 41+6 (weeks + days)
  • Expressed need for labour pain relief
  • Swedish speaking (well enough to understand written and oral instructions)

Exclusion Criteria:

  • No pharmacological pain relief within 24 hours prior to inclusion into the study
  • Severe preeclampsia
  • Treatment with oxytocin at the time point of allocation
  • Treatment with anticoagulant
  • Pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual Acupuncture
Manual stimulation
Device: Manual Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
Other Names:
  • Acupuncture
Experimental: Electro Acupuncture
Electrical and manual stimulation
Device: Electro Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
Other Names:
  • Acupuncture
No Intervention: Standard care
No acupunture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Epidural Analgesia
Time Frame: From start of treatment until birth
Frequecy of epidural analgesia
From start of treatment until birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Skövde

Investigators

  • Principal Investigator: Lena B Martensson, PhD, University of Skövde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 136-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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