Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Relief
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnant women admitted for induction of labor
- •Rupture premature or early of chorioamniotic membranes
- •Use of uterotonic drugs before the active phase
研究组 & 干预措施
Control Group
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.
干预措施: Routine care (Other)
Intervention Group
Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.
干预措施: Non-pharmacological resources (Other)
结局指标
主要结局
Pain Relief
时间窗: ten hours
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)
次要结局
- Moment That Women Requested Analgesia During the Active Phase of Labor(10 hours)
- Type of Delivery(10 hours)
- Number of Participants Whose Neonates Had:(10 hours)
- Evolution of Labor(10 hours)
- Number of Women Who Received Pharmacological Analgesia(10 hours)
- Number of Participants With:(10 hours)
研究者
Silvana Maria Quintana
Associate Professor
University of Sao Paulo