NCT01389128

Non-pharmacological Resources in Assisting Labor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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%.

Conditions

• Labour Pain

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-07-07
• Last updated: 2019-07-19
• Results posted: 2019-07-19

Locations

1 site across 1 country: Brazil