Non-pharmacological Resources in Assisting Labor

Labour Pain Clinical Trial

Official title:

Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389128
• Other study ID #: FR443033
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery. Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources. This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers. The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation. Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth. 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 to obtain the statistical significance of 5%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;

• 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

Exclusion Criteria:

• Pregnant women admitted for induction of labor

• Rupture premature or early of chorioamniotic membranes

• Use of uterotonic drugs before the active phase

Related Conditions & MeSH terms

• Labor Pain
• Labour Pain

Intervention

Other:
• Non-pharmacological resources
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.
• Routine care
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.

Locations

Country	Name	City	State
Brazil	Referral Center Women's Health - Mater	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of Labor	Amount of minutes, from admission to labor.	10 hours
Secondary	Moment That Women Requested Analgesia During the Active Phase of Labor	Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record	10 hours
Secondary	Number of Women Who Received Pharmacological Analgesia	Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.	10 hours
Secondary	Type of Delivery	Type of delivery at the end of the active phase of labor.	10 hours
Secondary	Number of Participants Whose Neonates Had:	Number and type of neonatal complications as reported in medical chart	10 hours
Secondary	Number of Participants With:	Number and type of maternal complications as reported in medical chart	10 hours