Labor Pain, Transcutaneous Electric Nerve Stimulation
Conditions
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.
Interventions
DEVICETENS
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.
DEVICETENS Placebo
Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
Sponsors
Hospital General Universitario de Castellón
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Spain
Contacts
Primary ContactManuel José Sos Gallén, PT, PGCert
Outcome results
None listed