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

Sponsored by:	Chang Gung Memorial Hospital
Information provided by:	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00148577

Purpose

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.

Condition	Intervention	Phase
Pain Relief at First Stage	Device: Transcutaneous Electrical Nerve Stimulation	Phase III

MedlinePlus related topics: Acupuncture

U.S. FDA Resources

Study Type:	Observational
Study Design:	Psychosocial, Longitudinal, Random Sample, Prospective Study
Official Title:	Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Acupuncture Points During the First Stage of Labour: a Randomised Controlled Trial

Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment:	100
Study Start Date:	August 2002
Estimated Study Completion Date:	December 2003

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.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148577

Locations

Taiwan
Chang Gung Memorial Hospital
Tao-Yuan, Taiwan, 333

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

Principal Investigator:

An-Shine Chao, MD

Chang Gung Memorial Hospital

More Information

Study ID Numbers:	NMRPG1159, no
Study First Received:	September 7, 2005
Last Updated:	September 7, 2005
ClinicalTrials.gov Identifier:	NCT00148577
Health Authority:	United States: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:

Pain Relief, TENS, Acupuncture Points

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009