Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Labour Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual Acupuncture

Manual stimulation

Group Type ACTIVE_COMPARATOR

Manual Acupuncture

Intervention Type DEVICE

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.

Electro Acupuncture

Electrical and manual stimulation

Group Type EXPERIMENTAL

Electro Acupuncture

Intervention Type DEVICE

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.

Standard care

No acupunture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Acupuncture Acupuncture

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No