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临床试验/NCT05750186
NCT05750186招募中不适用

The Effect of Abdominal Massage Applied After Surgery on Gastrointestinal Symptoms and Comfort Level

Istanbul University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
2
主要终点
Gastrointestinal Symptom Rating Scale

研究概览

简要总结

This research is carried out by research assistant Semiha Kurt under the supervision of Associate Professor Nuray TURAN.

In this research aimed to examine the effect of abdominal massage applied after surgical ıntervention on gastrointestinal symptoms and comfort level. The type of this study designed as randomized controlled experimental. The research hypotheses are as follows; H1: Abdominal massage applied after surgery reduces the gastrointestinal symptoms of patients.

H2: Abdominal massage applied after surgery increases the comfort level of patients.

The population of the research will consist patients who were hospitalized and underwent surgical intervention between January 2023 and July 2024 in the Orthopedics and Traumatology Clinic of the Istanbul Medical Faculty Hospital in Istanbul.The sample of the research will consist patients who cannot defecate for 3 days after surgery and who meet other sample selection criteria.

As a result of the power analysis (G*Power 3.0.10); at least 34 samples found to be sufficient for each group with f=0.20 effect size, 90% power and 5% margin of error (n1:34, n2:34). The number of samples determined as 68 (including the experimental and control groups).

Data will be collected through the Patient Information Form, Bristol Stool Scale, Gastrointestinal Symptom Rating Scale, General Comfort Scale, and Functional Independence Scale. The patient information form was prepared by the researchers in line with the literature. Permission was obtained from the scale owners for the scales to be used in the study.

In the implementation phase of the research; in the formation of the experimental and control groups, the assignment of the patients to the experimental and control groups will be provided by randomization in the computer. Abdominal massage will be applied to the patients in the experimental group twice a day, in the morning and evening, for 3 days. Each abdominal massage will be applied for 15 minutes. The routine practice of the clinic will continue in the patients in the control group.

Institutional permission from Istanbul Medical Faculty and ethics committee approval (Number: E-74555795-050.01.04-412448) from Istanbul University-Cerrahpasa Non-Interventional Research Ethics Committee obtained in order to conduct the study. Statistical analysis of research data will be done using a package program called SPSS (IBM SPSS Statistics 24). The expenses of the research will be covered by the researcher.

详细描述

Gastrointestinal symptoms that cause discomfort in patients and reduce their quality of life and comfort include disorders related to the esophagus, stomach, duodenum, jejunum, ileum, large intestine, sigmoid colon and rectum. These symptoms: reflux, abdominal pain, constipation, diarrhea and indigestion. After surgery, slowing of gastrointestinal system motility and change in eating habits can cause serious problems in patients by causing the development of gastrointestinal symptoms such as post-operative nausea, vomiting and hiccups. The development of these symptoms, on the other hand, prolongs the hospital discharge time of patients and may lead to increased costs. Prolonged persistence of abdominal distension after surgery; It may cause delayed wound healing due to increased pressure in the incision area, deep vein thrombosis in the legs due to decreased venous return, paralytic ileus and gastric dilation due to decreased blood flow in the intestine.Constipation; It can cause pain, nausea, vomiting, distention, feeding intolerance and contribute to the development of intestinal obstruction or perforation if not treated. There are many care and treatment methods, including pharmacological and non-pharmacological, stimulating gastrointestinal motility after surgical intervention. Abdominal massage, which is one of the non-pharmacological methods, is an important intervention in the management of gastrointestinal symptoms. Abdominal massage is a noninvasive application that stimulates bowel movements by applying patting, kneading and vibration movements over the abdominal wall to the area where the intestines are located. It increases peristalsis, creates a mechanical and reflex effect on the intestines, reducing the individual's feeling of pain and discomfort. The aim in the management of gastrointestinal symptoms is to prevent problems that may develop and to increase the quality of life and comfort of the patient by reducing these problems when they occur. Nurses are one of the team members who can diagnose and communicate with all aspects of healthy/sick individuals and their families, and take an active role in the management of gastrointestinal symptoms that may develop after surgical intervention and in the care of the individual. In this context, nurses have important roles and responsibilities. When the literature is examined, it has been observed that patients experience various problems related to gastrointestinal symptoms after surgical intervention. Abdominal massage, which is one of the non-pharmacological methods, is one of the most important independent nursing interventions in the management of gastrointestinal symptoms, as it is low cost and effective, without side effects for healthy/sick individuals and their families. In this context, this study planned to determine the effect of abdominal massage applied to patients after surgical intervention on gastrointestinal symptoms and comfort level.

In this research aimed to examine the effect of abdominal massage applied after surgical ıntervention on gastrointestinal symptoms and comfort level. The type of this study designed as randomized controlled experimental. The research hypotheses are as follows; H1: Abdominal massage applied after surgery reduces the gastrointestinal symptoms of patients.

H2: Abdominal massage applied after surgery increases the comfort level of patients.

The independent variables of the study the application of abdominal massage, the individual and disease characteristics of the patients; dependent variables are gastrointestinal symptom and comfort level scores.

The research will be carried out in the Orthopedics and Traumatology Clinic of Istanbul Medical Faculty Hospital in Istanbul between January 2023 and July 2024.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age and above,
  • Being conscious and cooperative,
  • Being able to read, write and speak Turkish, not have any cognitive, sensory and spiritual problems,
  • Not being pregnant,
  • The vital signs are within normal limits after the surgical intervention,
  • Failure to defecate for the first 3 days after the surgical intervention,
  • Not using pharmacological and non-pharmacological agents with laxative effect after the surgical intervention,
  • Continuing inpatient care and treatment in the orthopedics and traumatology clinic for at least 6 days,
  • His willingness and volunteering to participate in the study was included.

排除标准

  • Be less than 18 years old,
  • Not knowing how to read, write and speak Turkish,
  • Having any cognitive, sensory and spiritual problems,
  • Presence of conditions that prevent the application of abdominal massage (hernia, bowel cancer, history of abdominal surgery and Myocardial Infarction (MI), presence of ileostomy or colostomy and bleeding, etc.),
  • Being pregnant
  • The vital signs are not within normal limits after the surgical intervention,
  • Defecation in the first 3 days after the surgical intervention and using any pharmacological or non-pharmacological agent with laxative effect in this process, Continuing inpatient care and treatment in the orthopedics and traumatology clinic for less than 6 days,
  • Not willing to participate in the study.

结局指标

主要结局

Gastrointestinal Symptom Rating Scale

时间窗: Change in gastrointestinal symptoms at 6 days

It is divided into five sub-dimensions: abdominal pain, reflux, diarrhea, indigestion, and constipation. The scale includes 15 items, each scored on a seven-point Likert-type scale, with values ranging from "no discomfort" to "very severe discomfort". Higher scores on the scale indicate more severe symptoms.

General Comfort Scale

时间窗: Change in comfort level in 6 days

Evaluates the state of reaching the expected comfort increase result. The scale is scored on a four-point Likert-type scale, each ranging from "strongly agree" to "strongly disagree". The lowest score that can be obtained from the scale is 48, the median score is 120, and the highest score is 192. As the score obtained from the scale increases, the level of comfort perceived by the patient increases.

次要结局

  • Patient Information(Baseline)
  • Bristol Stool Scale(Up to 6 days after surgery)
  • Functional Independence Scale(Baseline)

研究者

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

Semiha Kurt

Research Assistant

Istanbul University

研究点 (2)

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