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Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor

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ClinicalTrials.gov Identifier: NCT01600495
Recruitment Status : Completed
First Posted : May 17, 2012
Results First Posted : March 17, 2014
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Alessandra Cristina Marcolin, University of Sao Paulo

Study Description
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Brief Summary:
The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.

Condition or disease Intervention/treatment Phase
Pain Other: Experimental TENS Phase 4

Detailed Description:
Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (lumbosacral massage) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p <0.05 for statistical significance of 5%.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primigravida
  • literate
  • A single fetus in vertex position
  • Low-risk Pregnancy
  • From 37 weeks of gestation
  • Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage
  • Labor in early spontaneous
  • No use of medications during the study period
  • Absence of cognitive or psychiatric problems
  • Intact membranes
  • No risk factors associated
  • Who wish to participate and signed the informed consent

Exclusion Criteria:

  • TENS procedure intolerance
  • Use of any medication or procedure that promotes pain relief
  • Use of pacemaker
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600495


Locations
Brazil
centro de referência para a saúde da mulher Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Alessandra C Marcolin, Professor Faculty of Medicine of São Paulo University
More Information
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Additional Information:
VAN DER SPANK, J.T.; CAMBIER, D.C.; DE PAEPE, H.M.C.; DANNEELS, L.A.G.; WITVROUW, E.E.; BEERENS, L. Pain relief in labour by transcutaneous electrical nerve stimulation (TENS). Arch Gynecol Obstet, v.264, p.131-136 May 2000.  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alessandra Cristina Marcolin, prof Dra., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01600495     History of Changes
Other Study ID Numbers: FR259137
First Posted: May 17, 2012    Key Record Dates
Results First Posted: March 17, 2014
Last Update Posted: October 5, 2015
Last Verified: September 2015

Keywords provided by Alessandra Cristina Marcolin, University of Sao Paulo:
pain
electric stimulation
nervous
transcutaneous
humanized childbirth