NCT03990441|Unknown
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Sponsor study identifier
interventional
46
1 country
1
Study Start
February 11, 2019
Actual (reported)Primary Completion
February 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 11, 2019
Actual (reported)May 28, 2019
Actual (reported)June 19, 2019
Actual (reported)February 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
TENS satisfaction
At leaving the labor room, assessed up to 3 hours after delivery.
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.
Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
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.
Hospital General Universitario de Castellón
Castellon, Castellón, 12004, Spain
Manuel José Sos Gallén, PT, PGCert
Cardenal Herrera University
First Submitted
May 28, 2019
First Posted
June 19, 2019
Study Start
February 11, 2019
Actual (reported)Primary Completion
February 2020
Estimated (date passed)TENS Efficacy in Pain Relief During Hysteroscopy
Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 19, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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