Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
|ClinicalTrials.gov Identifier: NCT01600495|
Recruitment Status : Completed
First Posted : May 17, 2012
Results First Posted : March 17, 2014
Last Update Posted : October 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Experimental TENS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||January 2013|
Experimental: Experimental TENS
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
Other: Experimental TENS
Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
No Intervention: control Group
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
- Classification of Pain During Labor by Visual Analogue Scale [ Time Frame: 30 minutes ]
To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.
Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)
- Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia [ Time Frame: 10 hours ]Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.
- Duration From Start of Labor Until Birth [ Time Frame: 10 hours ]The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.
- Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor. [ Time Frame: 10 hours ]Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600495
|centro de referência para a saúde da mulher Ribeirão Preto|
|Ribeirão Preto, São Paulo, Brazil, 14048-900|
|Principal Investigator:||Alessandra C Marcolin, Professor||Faculty of Medicine of São Paulo University|