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Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

Primary Purpose

Labour Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Manual Acupuncture
Electro Acupuncture
Sponsored by
University of Skövde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labour Pain focused on measuring acupuncture, labour, pain, pain relief, complementary

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • School of Life Sciences, University of Skövde

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Manual Acupuncture

Electro Acupuncture

Standard care

Arm Description

Manual stimulation

Electrical and manual stimulation

No acupunture

Outcomes

Primary Outcome Measures

Use of Epidural Analgesia
Frequecy of epidural analgesia

Secondary Outcome Measures

Full Information

First Posted
August 26, 2010
Last Updated
September 7, 2022
Sponsor
University of Skövde
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1. Study Identification

Unique Protocol Identification Number
NCT01197950
Brief Title
Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain
Official Title
A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Skövde

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labour Pain
Keywords
acupuncture, labour, pain, pain relief, complementary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Acupuncture
Arm Type
Active Comparator
Arm Description
Manual stimulation
Arm Title
Electro Acupuncture
Arm Type
Experimental
Arm Description
Electrical and manual stimulation
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No acupunture
Intervention Type
Device
Intervention Name(s)
Manual Acupuncture
Other Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Name(s)
Electro Acupuncture
Other Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Use of Epidural Analgesia
Description
Frequecy of epidural analgesia
Time Frame
From start of treatment until birth

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena B Martensson, PhD
Organizational Affiliation
University of Skövde
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Life Sciences, University of Skövde
City
Skövde
ZIP/Postal Code
SE-541 28
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26066641
Citation
Vixner L, Martensson LB, Schytt E. Acupuncture with manual and electrical stimulation for labour pain: a two month follow up of recollection of pain and birth experience. BMC Complement Altern Med. 2015 Jun 12;15:180. doi: 10.1186/s12906-015-0708-2.
Results Reference
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PubMed Identifier
22577468
Citation
Vixner L, Martensson LB, Stener-Victorin E, Schytt E. Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:943198. doi: 10.1155/2012/943198. Epub 2012 Apr 17.
Results Reference
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PubMed Identifier
27986648
Citation
Vixner L, Schytt E, Martensson LB. Associations between maternal characteristics and women's responses to acupuncture during labour: a secondary analysis from a randomised controlled trial. Acupunct Med. 2017 Jun;35(3):180-188. doi: 10.1136/acupmed-2016-011164. Epub 2016 Dec 16.
Results Reference
background
PubMed Identifier
24913704
Citation
Vixner L, Schytt E, Stener-Victorin E, Waldenstrom U, Pettersson H, Martensson LB. Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial. BMC Complement Altern Med. 2014 Jun 9;14:187. doi: 10.1186/1472-6882-14-187.
Results Reference
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Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

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