跳至主要内容
临床试验/NCT05201157
NCT05201157已完成不适用

The Effect of Acupressure on Postpartum Fatigue in Women Who Had Cesarean Delivery: A Randomized Controlled Study

resmiye kaya odabaş2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
2
主要终点
Visual Similarity Scale for Fatigue

研究概览

简要总结

Postpartum fatigue is common in women after cesarean section and it affects the woman and the baby. Many noninvasive applications help to overcome this problem. This study was planned as a randomized controlled trial to examine the effect of acupressure on postpartum fatigue in women who had a cesarean section. The research will be carried out between August 2021 and August 2022 with mothers who have had a cesarean section at Kocaeli University Research and Application Hospital. The research will be carried out with two groups as acupressure and control group. The sample number was calculated using the G*Power 3.1.9.2 program and the acupressure group: 60 and the control group: 60. In order to increase the analysis power, the number of people for each group was taken as 65 (n=130). It is planned to collect the data with the Descriptive Information Form and the Visual Similarity Scale for Fatigue. Acupressure will be applied to the mothers in the acupressure group once, once on the post-op day 0, twice on the post-op 1. day and once on the post-op 2. day, for a total of 4 times for six minutes, and no application will be made to the control group. Fatigue will be assessed with the Visual Similarity Scale for Fatigue before administration on post-op day 0 and after administration on post-op day 2. The data of the research will be evaluated using the Statistical Package for the Social Sciences 22.0 program. 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 for non-normally distributed variables. Pearson Correlation test will be applied to determine the relationship between the fatigue severity of the experimental 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 this study is to determine the effect of acupressure on postpartum fatigue in women who had cesarean section.

Hypotheses:

H0: There is no difference in fatigue between the acupressure group and the control group in women who had cesarean section.

H1: There is a difference in fatigue between the acupressure group and the control group in women who had a cesarean section.

This study was designed as a randomized controlled experimental study. The study was carried out in "Kocaeli University Research and Application Hospital" and "Health Sciences University Derince Training and Research Hospital" obstetrics service between August 2021 and August 2022 planned to be carried out.

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

  • Between the ages of 18-35,
  • Birth after 36th gestational week,
  • Multiparous
  • Caesarean section with regional anesthesia,
  • Mobilized,
  • Not having any health problems (Hypertension, tuberculosis, HIV, cancer, psychological disorders, etc.),
  • Does not have any problems preventing communication,
  • At least primary school graduate,
  • Able to speak and understand Turkish,
  • Volunteer women who agreed to participate in the study

排除标准

  • Having postpartum complications (bleeding, embolism, eclampsia, infection, etc.),
  • Having a hemoglobin level of less than 9 g/dl and a hematocrit level of less than 30%,
  • Having a body mass index of 40 and above,
  • Covid-19 test positive,
  • Having twin babies,
  • The baby is in the neonatal intensive care unit,
  • Having been diagnosed psychologically (such as depression) before,
  • Women who do not want to participate in the research will be excluded from the study.

结局指标

主要结局

Visual Similarity Scale for Fatigue

时间窗: This scale will be filled in by the mothers between in postoperative period on 2.days at 08.00-16:00 am]

The scale consists of 18 items, including fatigue (items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18) and energy (items 6, 7, 8, 9, 10). ) consists of two sub-dimensions. The scale consists of 10 cm horizontal lines with positive statements on one end and negative statements on the other. The lowest score obtained in the fatigue sub-dimension is 0, and the highest score is 130. In the energy sub-dimension, scores are calculated in the range of 0-50 points. The high score of the fatigue sub-dimension and the low score of the energy sub-dimension indicate that the severity of fatigue increases.

次要结局

未报告次要终点

研究者

发起方
resmiye kaya odabaş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

resmiye kaya odabaş

Principal Investigator

Aydin Adnan Menderes University

研究点 (2)

Loading locations...

相似试验