跳至主要内容
临床试验/NCT06927531
NCT06927531招募中不适用

Effects of Pilates Ball and Sacral Massage Applications on Labor Pain, Labor Duration and Childbirth Satisfaction: A Randomized Controlled Study

Ege University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
105
试验地点
1
主要终点
The intensity of pain will be measured with a visual pain scale.

研究概览

简要总结

As researchers, we believe that Pilates ball and manual sacral massage applications can be easily and cost-free applied in maternity clinics in our country. For all these reasons, this study was planned as a randomized controlled study to evaluate the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration, and labor satisfaction.

The research will be carried out between December 1, 2024 and May 1, 2025 in two public hospitals affiliated with the Gaziantep Provincial Health Directorate. The sample of the research will consist of 35 pregnant women in the Pilates ball group, 35 in the sacral massage group and 35 in the control group, totaling 105 pregnant women who meet the criteria for inclusion in the research. Applications to the intervention groups will be made during the active phase of labor. Personal Information Form, Labor Monitoring Form, Application Monitoring Form to record the number and duration of applications, Visual Analog Scale to assess labor pain, Partograph to assess labor duration and Labor Satisfaction Scale to assess maternal satisfaction will be used in data collection. Data will be analyzed with tests appropriate to normal distribution characteristics in the SPSS 24 package program. At the end of the research, the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration and labor satisfaction will be evaluated.

详细描述

Childbirth is one of the most special processes experienced in women's lives, significantly affecting their quality of life. Pain and fear experienced during the birth process are associated with many negative outcomes affecting the woman and the fetus/newborn, such as decreased childbirth satisfaction, preference for cesarean section, prolonged and difficult labor, and postpartum depression. Non-pharmacological methods that can be used to cope with labor pain are comfortable, safe, easy-to-use, and low-cost non-invasive methods that midwives can perform independently and in collaboration with the pregnant woman. Midwives working in delivery rooms should be able to apply non-pharmacological methods to cope with labor pain and should help teach and implement these methods by knowing their limitations and effects.

As researchers, we believe that Pilates ball and manual sacral massage applications can be easily and cost-free applied in maternity clinics in our country. For all these reasons, this study was planned as a randomized controlled study to evaluate the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration, and labor satisfaction.

The research will be carried out between December 1, 2024 and May 1, 2025 in two public hospitals affiliated with the Gaziantep Provincial Health Directorate. The sample of the research will consist of 35 pregnant women in the Pilates ball group, 35 in the sacral massage group and 35 in the control group, totaling 105 pregnant women who meet the criteria for inclusion in the research. Applications to the intervention groups will be made during the active phase of labor. Personal Information Form, Labor Monitoring Form, Application Monitoring Form to record the number and duration of applications, Visual Analog Scale to assess labor pain, Partograph to assess labor duration and Labor Satisfaction Scale to assess maternal satisfaction will be used in data collection. Data will be analyzed with tests appropriate to normal distribution characteristics in the SPSS 24 package program. At the end of the research, the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration and labor satisfaction will be evaluated.

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
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women over 18 years old and under 35 years old
  • •Term pregnancies (38-41 weeks gestation)
  • •Primiparous
  • •Those with a single live fetus
  • •Vertex development
  • •Those who do not have any risk factors during pregnancy (Dermatological disease, Preeclampsia, active membrane rupture, oligohydramnios and polyhydramnios, gestational diabetes, placental anomalies, intrauterine growth retardation, intrauterine dead fetus, macrosomic babies, fetal distress, etc.)
  • •Those who do not have any obstacles for Pilates ball application
  • •Those who do not have any chronic diseases (Hypertension, DM, ...)
  • •Those in the active phase of labor, those who have at least 1 hour of labor follow-up
  • •Pregnant women who voluntarily accept to participate in the study

排除标准

  • •Indications for Caesarean section (such as presentation disorder, breech presentation)
  • •Those who underwent induction
  • •Those whose labor duration was shorter than 1 hour or longer than 8 hours
  • •Those who underwent vacuum forceps or shoulder insertion

研究组 & 干预措施

sacral massage

Experimental

During labor, pregnant women will be given effleurage (stroking) and vibration (vibration) techniques to the sacral region in a comfortable position during contractions, once an hour for a maximum of 10 minutes.

干预措施: sacral massage (Other)

pilates ball

Experimental

During labor, pregnant women will be made to perform pelvic oscillation movements (full rotation of the hips, going right/left, coming forward and back, gently bouncing on a ball while holding on to the headboard) once an hour during the active phase of labor.

干预措施: pilates ball (Other)

control

No Intervention

Pregnant women in the control group will not be subjected to any intervention other than the routine practices of the clinic.

结局指标

主要结局

The intensity of pain will be measured with a visual pain scale.

时间窗: prebirth during

reduction in pain in intervention groups

次要结局

未报告次要终点

研究者

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

emine can

res. asst.

Ege University

研究点 (1)

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