Non-pharmacological Resources in Assisting Labor
Recruitment status was Recruiting
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 this protocol based on the 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
|Official Title:||Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial|
- Pain Relief Of Labour [ Time Frame: One Hour ] [ Designated as safety issue: No ]Evaluate the effectiveness of the protocol using the combination of non-pharmacological resources during the dilation in relieving the pain of mothers.
- evolution of labor [ Time Frame: 10 hours ] [ Designated as safety issue: No ]Evaluate the influence of the protocol using the combination of non-pharmacological resources in the duration of active phase of expansion and of the second stage of pregnant women.
- Request analgesia for pain relief during the active phase of labor [ Time Frame: 10 hours ] [ Designated as safety issue: No ]Assess the duration of time that the parturients request analgesia for pain relief during the active phase of labor.
- Evaluate the obstetric and neonatal outcomes of pregnant women subjected to the protocol [ Time Frame: 10 hours ] [ Designated as safety issue: No ]To evaluate the obstetric and neonatal outcomes of pregnant women subjected to the protocol using the combination of non-pharmacological resources in assisting labor and compare them to the control group
- Satisfaction of the parturient with labor and delivery [ Time Frame: 10 hours ] [ Designated as safety issue: No ]To assess the degree of satisfaction of mothers who undergo labor and birth
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
No Intervention: control group
Control Group (CG): Pregnant women who receive assistance from the protocol CRSM MATER, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.
Experimental: intervention group
Intervention Group (IG): Pregnant women who receive the application protocol using the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (6 and cm)and shower (> 7 cm);
Other: protocol with non pharmacological resources
application protocol using the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower;
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 protocol using 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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389128
|Contact: Silvana M Quintana, firstname.lastname@example.org|
|Contact: Centro de Referencia da Saude da Mulheremail@example.com|
|Referral Center Women's Health - Mater||Recruiting|
|Ribeirão Preto, São Paulo, Brazil|
|Contact: Silvana M Quintana, professor 551636022587 firstname.lastname@example.org|
|Contact: Rubneide B Gallo, physiotherap 551636022587 email@example.com|
|Sub-Investigator: Rubneide B Gallo, physiotherap|
|Principal Investigator:||Silvana M Quintana, professor||Faculty of Medicine of São Paulo University|