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

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

This study is ongoing, but not recruiting participants.
Information provided by Chang Gung Memorial Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Observational

Study Design ^†

Psychosocial, Longitudinal, Random Sample, Prospective Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Pain Relief at First Stage

Intervention ^†

Device: Transcutaneous Electrical Nerve Stimulation

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

100

Start Date ^†

August 2002

Completion Date

December 2003

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Taiwan

Administrative Information Fields

NCT ID ^†

NCT00148577

Organization ID

NMRPG1159

Secondary IDs ^††

Study Sponsor ^†

Chang Gung Memorial Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

An-Shine Chao, MD

Chang Gung Memorial Hospital

Information Provided By

Chang Gung Memorial Hospital

Verification Date

September 2005

First Received Date ^†

September 7, 2005

Last Updated Date

September 7, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.