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

Further Study Details: 

Expected Total Enrollment:  100

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.

Ages Eligible for Study:  20 Years   -   40 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

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

Study chairs or principal investigators

An-Shine Chao, MD,  Principal Investigator,  Chang Gung Memorial Hospital   

Study ID Numbers:  NMRPG1159; no
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148577
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13