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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Other: Experimental TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT01600495

FR259137

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 46 patients

Sex: Female

Ages: 15 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Experimental TENS

Experimental group

Description:

TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm

Treatment:

Other: Experimental TENS

control Group

No Intervention group

Description:

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.