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

Not Applicable

• Conditions: Labor Pain; Transcutaneous Electric Nerve Stimulation
• Interventions: Device: TENS Placebo; Device: TENS

• Registration Number: NCT03990441
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-11
• Study First Submitted: 2019-05-28
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-17
• Last Update Submitted: 2019-06-17
• Study First Posted: 2019-06-19
• Last Update Posted: 2019-06-19
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Women attending routinary fetal monitoring before labor

Exclusion Criteria

• Multiparous
• Scheduled cesarean
• Implantable Cardioverter Defibrillator (ICD) or pacemaker
• Epilepsy
• Fetal malformation
• Language barrier

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain intensity measure	Start of intervention, each 30 minutes during intervention, end of intervention (when neuraxial anesthesia is applied -if the woman demands it- or after delivery, assessed up to 10 hours from intervention's start).	Self reported pain intensity. Score 0-10 (0 = no pain, 10 = pain as bad as can be), using a 0-10 pain scale combined with colored faces pain scale, for measuring the change of pain.

Secondary Outcome Measures

Name	Time	Method
TENS satisfaction	At leaving the labor room, assessed up to 3 hours after delivery.	Self reported interest on use of TENS on future deliveries. Score 0-10 (0 = no way, 10 = absolutely necessary)

Trial Locations

Locations (1)

Hospital General Universitario de Castellón; 🇪🇸 Castellón De La Plana, Castellón, Spain