跳至主要内容
临床试验/NCT05251818
NCT05251818已完成不适用

Effect of Acupressure on Bowel Functions After Cesarean Section: A Randomized Controlled Trial

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年7月10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
61
试验地点
2
主要终点
Time to defecate

研究概览

简要总结

Enema application to pregnant women and prohibition of oral feeding before cesarean section, general anesthesia applied during cesarean section, pain in the post-cesarean period, limitation of movement, insufficient fluid intake, low-fiber diet, hospital environment and drugs such as narcotics cause constipation. In addition, one of the most common complications after abdominal surgeries is postoperative ileus. Many noninvasive applications help to overcome this problem. This study was planned as a randomized controlled trial to examine the effect of acupressure on bowel functions after cesarean section. The research will be carried out between July 2021 and July 2022 at the Samsun Training and Research Hospital Gynecology and Pediatrics Hospital affiliated to the Samsun Provincial Health Directorate. 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: 26 and the control group: 26. In order to increase the analysis power, the number of people for each group was taken as 30 (n=60). It is planned to collect the data with the Postpartum Information Form. After the women in the acupressure group come to the service, 2 applications will be made in the first postpartum hour and 3 hours after the first application, and no application will be made to the control group. Intestinal sounds will be monitored every hour until the first bowel sounds are heard, and the "Postpartum Registration Form" given to the woman will be received and recorded at the post-op 24th hour. 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 percentage, arithmetic mean±standard deviation, median and minimum-maximum values will be given. Student t test, ANOVA test will be used for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not. Type 1 error level will be taken as 0.05. Pearson Correlation test will be applied to determine the relationship between the intestinal functions of the experimental group and the tests. Statistical significance level will be accepted as p<0.05

详细描述

H01: There is no difference between the acupressure and control groups in terms of hearing time of bowel sounds.

H02: There is no difference in gas removal time between acupressure and control groups.

H03: There is no difference between the acupressure and control groups in terms of time to defecation.

This study was designed as a randomized controlled experimental study. The study will be carried out between July 2021 and July 2022 in the "Samsun Training and Research Hospital Gynecology and Pediatrics Hospital gynecology service".The universe of the research will be women who gave cesarean section under general anesthesia in Samsun Training and Research Hospital, Gynecology and Pediatrics Hospital.

The G-Power program was used to determine the sample of the study and it was planned to recruit 60 women in total (acupressure group: 30 women, control group: 30 women). The data of the research will be collected with the Postpartum Information Form created by the researcher. Which group the participants will be in will be determined by the full randomization technique on the website www.randomizer.org. After obtaining the permission of the ethics committee and the institution to carry out the study, the women who had a cesarean section will be met by going to the institution. Mothers who meet the research criteria will be informed about the purpose, content and methods of the research, and verbal and written consent will be obtained from those who want to participate. The researcher will fill in the "Postpartum Information Form" by interviewing the pregnant women face-to-face before the cesarean section, examining their socio-demographic and obstetric characteristics, and the operation information from the patient's file after the cesarean section.

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,
  • Having a cesarean section with general anesthesia,
  • After the operation, non-narcotic and the same type of analgesic substance is applied to provide pain control,
  • Able to speak and understand Turkish,
  • Postpartum women with at least primary school graduates will be included in the study.

排除标准

  • Being obese (BMI≥30),
  • Opioid medication given in the post-op period,
  • Any disease related to the digestive system,
  • Having a history of abdominal surgery,
  • Chronic constipation or irregularity in defecation habits,
  • Having any chronic disease (such as diabetes, hypertension, heart failure),
  • Pregnancy complications (such as preeclampsia, gestational diabetes),
  • The baby is in the intensive care unit,
  • Having any physical problem that will prevent the application of acupressure to LI4 and TH 6 points,
  • Women who develop disorders or insufficiency related to fluid-electrolyte balance, acid-base balance and tissue perfusion during and after the operation will not be included in the study.

结局指标

主要结局

Time to defecate

时间窗: First defecation up to one week after cesarean section

Questioning every 12 hours until the first stool output

First bowel sound

时间窗: until the first bowel sound to 24 hours

Bowel sounds will be heard from the abdominal region of the woman with a stethoscope every hour.

Gas removal time

时间窗: until the first gassing up to 24 hours

Hourly follow-up until the first gas removal time is heard

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

resmiye kaya odabaş

Investigator

Aydin Adnan Menderes University

研究点 (2)

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