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

NCT ID: NCT00148577

Last Updated: 2005-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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Pain Relief at First Stage

Keywords

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Pain Relief, TENS, Acupuncture Points

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Principal Investigators

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An-Shine Chao, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NMRPG1159

Identifier Type: -

Identifier Source: org_study_id