Clinical trial NCT01600495: Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Official title: Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
electric stimulation
nervous
transcutaneous
humanized childbirth
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%.

Eligibility 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

Primary outcomes:
measure: Classification of Pain During Labor by Visual Analogue Scale
timeFrame: 30 minutes
Secondary outcomes:
measure: Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia
timeFrame: 10 hours
measure: Duration From Start of Labor Until Birth
timeFrame: 10 hours
measure: Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.
timeFrame: 10 hours
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: centro de referência para a saúde da mulher Ribeirão Preto
state: São Paulo
Study officials:
affiliation: Faculty of Medicine of São Paulo University
name: Alessandra C Marcolin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.