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

NCT03990441 | Unknown

• 1 other identifier: SOS1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous Electric Nerve Stimulation; Labor Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity measure

  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.

  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).

Secondary Outcomes (1)

• TENS satisfaction

  At leaving the labor room, assessed up to 3 hours after delivery.

Study Arms (2)

Intervention

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Device: TENS Placebo

Interventions

TENS DEVICE

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.

Intervention

TENS Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Women attending routinary fetal monitoring before labor

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead
• Hospital General Universitario de Castellón: collaborator

Study Sites (1)

Hospital General Universitario de Castellón

Castellon, Castellón, 12004, Spain

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Manuel José Sos Gallén, PT, PGCert

  Cardenal Herrera University

  STUDY DIRECTOR

Central Study Contacts

Manuel José Sos Gallén, PT, PGCert

CONTACT

+34610736702; sos@pipeline.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 19, 2019
• Study Start: February 11, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)