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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain|
- Experience of labour pain [ Time Frame: From start of treatment until birth ] [ Designated as safety issue: No ]
- Use of epidural analgesia [ Time Frame: From start of treatment until birth ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Manual Acupuncture||
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 Name: Acupuncture
|Experimental: Electro Acupuncture||
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 Name: Acupuncture
|No Intervention: Standard care|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197950
|School of Life Sciences, University of Skövde|
|Skövde, Sweden, SE-541 28|
|Principal Investigator:||Lena B Martensson, PhD||University of Skövde|