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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Chang Gung Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00148577
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00148577     History of Changes
Other Study ID Numbers: NMRPG1159
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Pain Relief, TENS, Acupuncture Points

ClinicalTrials.gov processed this record on June 18, 2013