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

NCT03990441 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-06-19

No results posted yet for this 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.

Conditions

  • Transcutaneous Electric Nerve Stimulation
  • Labor Pain

Interventions

DEVICE

TENS

TENS application using the TensMed S82 (Enraf Nonius). Current parameters: balanced symmetric biphasic square waveform, continuous stimulation, frequency 80 Hz, pulse duration modulated between 250 and 290 μs, modulation time 5 seconds. Self-adhesive electrodes of 50 x 90 mm applied paravertebrally to 2 cm. of the spinous apophysis. Use of two channels with independent intensity (mA): electrodes of the first channel applied at level T10-L1 and second channel ones at level S2-S4. Maximum intensity without reaching pain, increasing the intensity throughout the application to maintain this level. Start of the intervention when the woman expresses pain. End of the intervention when neuraxial anesthesia is applied (if the woman demands it) or after delivery.

DEVICE

TENS Placebo

Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.

Sponsors & Collaborators

  • Hospital General Universitario de Castellón

    collaborator OTHER

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    lead OTHER

Principal Investigators

  • Manuel José Sos Gallén, PT, PGCert · Cardenal Herrera University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2020-02-29
Completion
2020-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990441 on ClinicalTrials.gov