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

Pain Clinical Trial

Official title:

Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600495
• Other study ID #: FR259137
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2011
• Last updated: September 18, 2015
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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).

Locations

Country	Name	City	State
Brazil	centro de referência para a saúde da mulher Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of Pain During Labor by Visual Analogue Scale	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)	30 minutes	No
Secondary	Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia	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.	10 hours	No
Secondary	Duration From Start of Labor Until Birth	The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.	10 hours	No
Secondary	Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.	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.	10 hours	No

External Links

•   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.