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| Name | Class |
|---|---|
| Hospital General Universitario de Castellón | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Same application as Intervention, but using 0,1 mA as fixed intensity on both channels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| TENS satisfaction | Self reported interest on use of TENS on future deliveries. Score 0-10 (0 = no way, 10 = absolutely necessary) | At leaving the labor room, assessed up to 3 hours after delivery. |
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Inclusion Criteria:
- Women attending routinary fetal monitoring before labor
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel José Sos Gallén, PT, PGCert | Contact | +34610736702 | sos@pipeline.es |
| Name | Affiliation | Role |
|---|---|---|
| Manuel José Sos Gallén, PT, PGCert | Cardenal Herrera University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Castellón | Recruiting | Castellon | Castellón | 12004 | Spain |
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| TENS Placebo | Device | Same application as Intervention, but using 0,1 mA as fixed intensity on both channels. |
|
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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