Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor

Last updated: June 17, 2019
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Pain

Treatment

N/A

Clinical Study ID

NCT03990441
SOS1
  • Ages > 18
  • Female

Study Summary

This study seeks to verify the analgesic efficacy of TENS during the first stage of labor applying TENS parameters that, according to with the evidence, can be effective for this application and discarding the placebo effect according to the methodological recommendations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women attending routinary fetal monitoring before labor

Exclusion

Exclusion Criteria:

  • Multiparous

  • Scheduled cesarean

  • Implantable Cardioverter Defibrillator (ICD) or pacemaker

  • Epilepsy

  • Fetal malformation

  • Language barrier

Study Design

Total Participants: 46
Study Start date:
February 11, 2019
Estimated Completion Date:
March 31, 2020

Study Description

TENS is a non-pharmacological alternative for pain control during labor. Although it's a method that has been used for decades, there is not enough evidence on its efficacy, so it's considered ineffective in the Spanish and British guidelines of clinical practice. The present study seeks to verify the analgesic efficacy of TENS by applying the electrodes in the spinal nerve roots associated with labor pain and using conventional TENS with parameters that, according to the evidence, may be effective for this application.

Connect with a study center

  • Hospital General Universitario de Castellón

    Castellón De La Plana, Castellón 12004
    Spain

    Active - Recruiting

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