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

Pain Relief at First Stage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00148577
• Other study ID #: NMRPG1159
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: August 2002
• Est. completion date: December 2003

Study information

• Verified date: September 2005
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Random Sample, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Pain Relief at First Stage

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Tao-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan,