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临床试验/NCT05424861
NCT05424861已完成不适用

Acupressure Application for Relief of Postpartum Uterine Pain During Breastfeeding: A Randomized Controlled Study

Kocaeli University2 个研究点 分布在 2 个国家目标入组 122 人开始时间: 2022年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
Visual analog scale for assessing postpartum uterine pain

研究概览

简要总结

Postpartum uterine pain is an important part of the postpartum period and is a concern for women, which can negatively affect maternal-neonatal attachment and breastfeeding. Acupressure allows midwives to make evidence-based independent practice in controlling postpartum uterine pain. The aim of this study is to determine the effectiveness of acupressure, which is a non-pharmacological intervention, for postpartum uterine pain after vaginal delivery. The research will be carried out between February 2022 and December 2022 with mothers who gave vaginal birth at Health Sciences University Kocaeli Derince Training and Research Hospital. The research will be carried out with two groups as acupressure and control groups. The sample number was calculated using the G*Power 3.1.9.2 program and the acupressure group: 61 and the control group: 61. It was planned to collect the research data with the Introductory Information Form and Visual Analog Scale in which Postpartum Uterine Pain was evaluated. Postpartum 6-24 days in the acupressure group. Acupressure will be applied once between hours, just before breastfeeding. The visual analog scale, in which the introductory information form is filled by the researcher and the pain score is evaluated, will be marked by the participant once before breastfeeding, once at the 10th minute of breastfeeding, and once at the 20th minute, in total 3 times. No application will be made to the control group. The data of the research will be evaluated using the Statistical Package 22.0 program for Social Sciences. In the evaluation of the data; descriptive statistics will be given as percentage, arithmetic mean±standard deviation, median and minimum-maximum values. Independent two-sample t-test will be used for normally distributed variables and Mann-Whitney U test will be used for non-normally distributed variables. Pearson Correlation test will be applied to determine the relationship between the pain intensity of the acupressure group and the tests and to determine the relationship between the tests. Statistical significance level will be accepted as p<0.05.

详细描述

Aim: The aim of our study is to determine the effectiveness of acupressure, which is a non-pharmacological intervention, for postpartum uterine pain after vaginal delivery.

Hypothesis(s):

H0: Acupressure application during breastfeeding after vaginal delivery has no effect on reducing uterine pain.

H1: Acupressure application during breastfeeding after vaginal delivery has an effect on reducing uterine pain.

Type of Research: This study was designed as a randomized controlled experimental study.

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

入选标准

  • Having a single and live baby between 37-42 weeks of gestation,
  • Normal spontaneous vaginal delivery,
  • Multiparous,
  • Having a baby weighing 2-4 kilograms,
  • No general anesthetic agent was used at birth,
  • Have not used a non-pharmacological method for pain before,
  • Having a Visual Analogue Scale (VAS) score of 4 and above for uterine pain before breastfeeding,
  • Not having breastfeeding problems,
  • Not having any health problems (Tuberculosis, HIV, cancer, etc.),
  • Having given birth at least 6 hours ago,
  • Does not have any problems preventing communication,
  • Able to read and write,
  • Able to speak and understand Turkish,
  • Volunteer mothers who agreed to participate in the study will be included.

排除标准

  • Having a situation that prevents breastfeeding (galactosemia, congenital anomalies, etc.),
  • Having postpartum complications (bleeding, infection, etc.),
  • Separated from her baby for any reason after birth (in cases where the mother or baby is referred, hospitalized in intensive care or isolated),
  • Having lost her baby,
  • Having any complications during pregnancy (gestational diabetes, preeclampsia, Rh incompatibility, heart disease, etc.),
  • With uterine anomaly,
  • Tissue integrity deteriorated in the area to be treated,
  • Taking painkillers in the last 6 hours,
  • Smoking or using alcohol,
  • Those with positive Covid-19 test will be excluded from the study. In addition, those who want to leave the research at any stage of the research will be excluded from the research.

结局指标

主要结局

Visual analog scale for assessing postpartum uterine pain

时间窗: This scale will be completed by the participants at the 20th minute of breastfeeding.

The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

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

sena dilek

Principal Investigator

Kocaeli University

研究点 (2)

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