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临床试验/NCT05283707
NCT05283707Unknown不适用

The Effect of "Paula Method Exercises" on the Prevention of Postoperative Distention and Pain Due to Distention After Cesarean Section: A Randomized Controlled Study

Akdeniz University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Number of bowel movements

研究概览

简要总结

Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension.

Method: The study was planned as a double-blind, randomized controlled experimental study.

The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study.

The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample.

The data of the study were collected using the Introductory Information Form, the Postoperative Follow-up Form, and the McGill Pain Scale Form.

The women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher.

Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after cesarean section.

详细描述

Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension. The gastrointestinal system problems experienced by all individuals undergoing abdominal surgery are important as they affect both the mother and the baby during the post-cesarean section period.

Method: The study was planned as a double-blind, randomized controlled experimental study. The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study. The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample. Equal numbers of 80 women who agreed to participate in the study were assigned to the intervention and control groups (https://www.random.org) using the simple randomization method using a simple random numbers table. Women in the intervention and control groups received standard postoperative care in the clinic after cesarean section. In addition, the women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher, and the "Paula Method Exercises Card" and "Paula Method Exercises Practice Video" were used, which facilitated the practice of the exercises. Paula Method Exercises were applied to the women in the intervention group by the researcher for 10-15 minutes on postoperative day 0, day 1 and day 2. The data of the study were collected with the "Descriptive Information Form", "Postoperative Follow-up Form" and "McGill Pain Scale Short Form". To both research groups; "Postoperative Follow-up Form" and "McGill Pain Scale Short Form" were applied between 6th and 8th hours, 1st and 2nd days after cesarean section. After the data are collected, the women in the control group will be given Paula Method Exercises training before discharge.

Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Between the ages of 18-45, who are planned to have an elective Cesarean Section (CD) under spinal anesthesia,
  • Admitted to the service within six hours after cesarean section,
  • No chronic Charles Bonnet Syndrome (CBS) disease,
  • No history of serious (ilostomy, cholastomy, irritable bowel syndrome, etc.) disease related to the gastrointestinal tract,
  • Those who volunteered to participate in the study and whose consent was obtained,
  • No complications developed during or after the surgery,
  • Women who do not have intellectual disability or perception problems and do not have communication difficulties will be included in the study.
  • In order not to affect the research results; If there are women in the intervention and control group in the same hospital room, the last woman who was hospitalized in the same room will be excluded from the study.

排除标准

  • Enema made,
  • Any complication developed and taken to the intensive care unit,
  • Not complying with the application process,
  • The state of consciousness is not clear / will not be able to participate in the applications,
  • Women who cannot communicate for any reason (hearing/speech/hearing, etc.) will be excluded from the research.
  • Discharged before two days after cesarean section

结局指标

主要结局

Number of bowel movements

时间窗: Bowel sounds will be listened to 6 times. The first measurement will be done between 6-8 hours after cesarean section, the second measurement will be done in the morning on the post-op 1st day, and the third in the morning on the 2nd post-op day.

An increase in womens' number of bowel movements is a measure of outcome. This increase will be counted by listening with a stethoscope. For the first measurement, bowel sounds will be heard 2 times between 6-8 hours after cesarean section, before and after the intervention. For the second measurement, bowel sounds will be listened to 2 times in the morning on the post-op 1st day after cesarean section, before and after the intervention. For the third measurement, bowel sounds will be listened to 2 times in the morning on the post-op 2nd day after cesarean section, before and after the intervention. Bowel sounds will be listened to 6 times in total. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will decrease the time to pass gas and defecation (in hours) and increase the bowel sounds (in numbers). Significance level is set at p\<0.05 in analyzes.

Visual Analogue Scale

时间窗: Pain will be evaluated 6 times. The first measurement will be made between 6-8 hours after cesarean section, the second measurement will be made in the morning on the 1st postoperative day, and the third in the morning on the 2nd day after the operation.

Application of Paula Method Exercises in the postoperative period after cesarean section; It is predicted that the Visual Analogue Scale score will decrease in the evaluation of pain due to distention. The minimum value is 0, the maximum value is 10. A low score indicates the success of the attempt. Significance level is set at p\<0.05 in analyzes.

First gas extraction time

时间窗: Until you take your first gas; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.

Until the patient has his first gas; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p\<0.05.

First defecation extraction time

时间窗: Until you take your first defecation; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.

Until the patient has his first defecation; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p\<0.05.

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

Rabiye DEMIR ISIK

Lecturer

Akdeniz University

研究点 (2)

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