Non-pharmacological Resources in Assisting Labor

NCT01389128 | Completed Results DMC

• 1 other identifier: FR443033
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.

Conditions

Labour Pain

Keywords

labor; pain; massage; natural birth

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were: * Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball) * Phase II: 5-6cm of cervical dilation (lumbosacral massage) * Phase III: 7cm or higher cervical dilation (warm shower)

  ten hours

Secondary Outcomes (6)

• Evolution of Labor

  10 hours

• Moment That Women Requested Analgesia During the Active Phase of Labor

  10 hours

• Number of Women Who Received Pharmacological Analgesia

  10 hours

• Type of Delivery

  10 hours

• Number of Participants Whose Neonates Had:

  10 hours

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.

Other: Routine care

Intervention Group

EXPERIMENTAL

Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.

Other: Non-pharmacological resources

Interventions

Non-pharmacological resources OTHER

A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows: * Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes; * Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and, * Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm.

Intervention Group

Routine care OTHER

Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.

Control Group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primigravida;
• Pregnancy only;
• Gestational age ≥ 37 weeks;
• Presentation fetal head
• Chorioamniotic intact membranes
• Working with spontaneous onset of labor
• Admission at the beginning of active phase dilation (4-5 cm)
• Lack of maternal and fetal pathologies
• Literacy - primary education
• Absence of cognitive problems

You may not qualify if:

• Pregnant women admitted for induction of labor
• Rupture premature or early of chorioamniotic membranes
• Use of uterotonic drugs before the active phase

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Referral Center Women's Health - Mater

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (2)

• Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.

  PMID: 15295342 BACKGROUND

• Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.

  PMID: 29289579 DERIVED

MeSH Terms

Conditions

Labor Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Silvana Maria Quintana
• Organization: University of São Paulo

quintana@fmrp.usp.br

+55(16)36022813

Study Officials

• Silvana M Quintana, professor

  Faculty of Medicine of São Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 7, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Locations

BR (1)