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临床试验/NCT01392053
NCT01392053已完成4 期

Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
46
试验地点
2
主要终点
Effectiveness of Massage Therapy in Pain Relief During Labor.

研究概览

简要总结

The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire.

详细描述

The pain in labor appears as a subjective experience, individual interaction involving a broad physiological, psychosocial and environmental influences, representing one of the main clinical signs of this phase. Despite presenting an important biological function, is today well established the need for their relief, since its persistence is associated with harmful effects on mother and fetus. Among the available non-pharmacological resources, we highlight the massage therapy that has shown positive effects in relieving pain and promoting the comfort of the mother. The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire. 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
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous
  • A single fetus in vertex position
  • Low-risk Pregnancy
  • From 37 weeks of gestation
  • Cervical dilatation from 4 cm with normal uterine dynamics in this phase
  • Labor in early spontaneous
  • No use of medications during the study period
  • Absence of cognitive or psychiatric problems
  • Intact membranes
  • No risk factors associated
  • You want to participate and signing the informed consent

排除标准

  • Use of drugs or any procedure that aims to relieve pain
  • Intolerance to the application of massage therapy
  • Presence of dermatological conditions that indicate against the application of massage therapy

结局指标

主要结局

Effectiveness of Massage Therapy in Pain Relief During Labor.

时间窗: 30 minutes

The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.

次要结局

  • Obstetric Outcomes - Duration of Labour(10 hours)
  • Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.(30 minutes)
  • Pharmacological Analgesia Request According to the Cervical Dilation.(10 hours)
  • Obstetric Outcomes - Delivery(10 hours)
  • Obstetric Outcome - Moment of Corioamniorrhexis(10 hours)
  • Obstetric Outcomes - Moment of Utilization of Oxytocin(10 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvana Maria Quintana

Associate Professor

University of Sao Paulo

研究点 (2)

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