Back to resultsAnalgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor
Primary Purpose
Transcutaneous Electric Nerve Stimulation, Labor Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TENS
TENS Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Transcutaneous Electric Nerve Stimulation
Eligibility Criteria
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
Sites / Locations
- Hospital General Universitario de CastellónRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
TENS satisfaction
Self reported interest on use of TENS on future deliveries. Score 0-10 (0 = no way, 10 = absolutely necessary)
Full Information
NCT ID
NCT03990441
First Posted
May 28, 2019
Last Updated
June 17, 2019
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Collaborators
Hospital General Universitario de Castellón
1. Study Identification
Unique Protocol Identification Number
NCT03990441
Brief Title
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor
Official Title
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor. Double-blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Collaborators
Hospital General Universitario de Castellón
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcutaneous Electric Nerve Stimulation, Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
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 Type
Device
Intervention Name(s)
TENS Placebo
Intervention Description
Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
Primary Outcome Measure Information:
Title
Pain intensity measure
Description
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.
Time Frame
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 Outcome Measure Information:
Title
TENS satisfaction
Description
Self reported interest on use of TENS on future deliveries. Score 0-10 (0 = no way, 10 = absolutely necessary)
Time Frame
At leaving the labor room, assessed up to 3 hours after delivery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel José Sos Gallén, PT, PGCert
Phone
+34610736702
Email
sos@pipeline.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel José Sos Gallén, PT, PGCert
Organizational Affiliation
Cardenal Herrera University
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General Universitario de Castellón
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel José Sos Gallén
Phone
+34610736702
Email
sos@pipeline.es
First Name & Middle Initial & Last Name & Degree
Cesar Romeo Cabrera León, PhD
First Name & Middle Initial & Last Name & Degree
Manuel José Sos Gallén, PT, PGCert
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor
We'll reach out to this number within 24 hrs