Pain Relief by Applying TENS on Acupuncture Points During the First Stage of Labour - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

September 7, 2005

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pain Relief by Applying TENS on Acupuncture Points During the First Stage of Labour

Official Title ^ICMJE

Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Acupuncture Points During the First Stage of Labour: a Randomised Controlled Trial

Brief Summary

We aimed to establish the reduction of labor pain by applying TENS at acupuncture points during the first stage of labour, to assess their efficacy, and to ascertain their acceptability.

Detailed Description

We conducted a double-blind, placebo-controlled randomised trial involving healthy parturient at term pregnancy using TENS on 4 acupuncture points (Li 4 and Sp 6) (n=50) and the placebo group (n=50). Visual analogue scale (VAS) was used to assess the effect on pain before the application, 30 minutes and 60 minutes after TENS. The objective parameter of outcome was the score of VAS decreased in each groups. A post-partum questionnaire was given 24 hours later to evaluate the satisfaction and the use of this pain relieving method for the next delivery.

Study Phase

Phase III

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Psychosocial, Longitudinal, Random Sample, Prospective Study

Condition ^ICMJE

Pain Relief at First Stage

Intervention ^ICMJE

Device: Transcutaneous Electrical Nerve Stimulation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

100

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The inclusion criteria were:

Voluntary informed participation to the study
An initial wish to deliver without epidural analgesia
Planned vaginal childbirth (non-obstetrical complicated pregnancy)
Fetal vertex presentation
Term pregnancy (>37 weeks of gestation)
Apply at 1st stage of labour and excluded if cervical dilatation > 5 cm
Age between 20 and 40 years
Chinese speaking, capable to understand the study
No experience of pain relief by systemic or epidural anesthesia in previous delivery
No experience in acupuncture or TENS in other field
Had no heart disease nor using pace-maker.

Exclusion Criteria:

Cervical dilatation > 5 cm
Experience of pain relief by systemic or epidural anesthesia in previous delivery
Experience in acupuncture or TENS in other field
Had heart disease or using pace-maker

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00148577

Responsible Party

Study ID Numbers ^ICMJE

NMRPG1159, no

Study Sponsor ^ICMJE

Chang Gung Memorial Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

An-Shine Chao, MD

Chang Gung Memorial Hospital

Information Provided By

Chang Gung Memorial Hospital

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP