Non-pharmacological Resources in Assisting Labor
2019年5月8日 更新者：Silvana Maria Quintana、University of Sao Paulo
Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial
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.
研究概览
详细说明
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%.
研究类型
介入性
注册 (实际的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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São Paulo
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Ribeirão Preto、São Paulo、巴西
- Referral Center Women's Health - Mater
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 40年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：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.
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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.
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实验性的：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.
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A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Relief
大体时间：ten hours
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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:
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ten hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Evolution of Labor
大体时间：10 hours
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Amount of minutes, from admission to labor.
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10 hours
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Moment That Women Requested Analgesia During the Active Phase of Labor
大体时间：10 hours
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Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief.
Data obtained from medical record
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10 hours
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Number of Women Who Received Pharmacological Analgesia
大体时间：10 hours
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Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
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10 hours
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Type of Delivery
大体时间：10 hours
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Type of delivery at the end of the active phase of labor.
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10 hours
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Number of Participants Whose Neonates Had:
大体时间：10 hours
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Number and type of neonatal complications as reported in medical chart
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10 hours
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Number of Participants With:
大体时间：10 hours
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Number and type of maternal complications as reported in medical chart
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10 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Silvana M Quintana, professor、Faculty of Medicine of São Paulo University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2012年7月1日
研究注册日期
首次提交
2011年6月30日
首先提交符合 QC 标准的
2011年7月6日
首次发布 (估计)
2011年7月7日
研究记录更新
最后更新发布 (实际的)
2019年7月19日
上次提交的符合 QC 标准的更新
2019年5月8日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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