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临床试验/NCT04837378
NCT04837378已完成不适用

Effects of Abdominal Massage and In-Bed Exercise on Gastrointestinal Complications and Patient Comfort in Intensive Care Patients Eating Enterally

Inonu University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年4月15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
130
试验地点
2
主要终点
The effect of abdominal massage on patient comfort

研究概览

简要总结

Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.

This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.

详细描述

Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.

This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.

The research is planned to be completed between April 15, 2021 and July 15, 2022. The universe of the study, which was conducted as a randomized controlled study model, consisted of patients with intubated enteral nutrition in the internal intensive care units of Diyarbakır Gazi Yaşargil Training and Research Hospital and Dicle University Medical Faculty. Participants were planned to be assigned to the experimental and control groups by stratification and block randomization (Abdominal massage group = 46 participant, in-bed exercise group = 46 participant and control group = 46 participant). Demographic Characteristics Form, Enteral Nutrition Follow-up Form, Richmond Agitation-Sedation Scale, Intensive Care Pain Observation Scale and Comfort Behavior Checklist were used to collect data. According to the characteristics of the data, t test, ANOVA test, Mann Whitney U test and correlation were measured in independent groups.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients connected to a mechanical ventilator
  • Patients who started enteral feeding with a nasogastric tube at least 24 hours ago
  • Patients with no injuries to the extremity and abdominal area
  • Patients without intestinal obstruction
  • Patients who have not received abdominal radiotherapy and have not undergone abdominal surgery during the last six weeks
  • Patients with Glasgow Coma Score (GCS) > 3
  • Patients with Acute Physiology and Chronic Health Evaluation (APACHE II)> 16
  • Patients given consent by their first-degree relative

排除标准

  • • Patients whose enteral feeding was discontinued during the study
  • Patients who show signs of infection due to VAP or other infections during or before the study

结局指标

主要结局

The effect of abdominal massage on patient comfort

时间窗: About 6 months

Comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after abdominal massage.

The effect of in-bed exercise on patient comfort

时间窗: About 6 months

The comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after the in-bed exercise.

The effect of abdominal massage on gastrointestinal complications

时间窗: About 6 months

Abdominal massage was repeated for 3 days, and gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status and blood glucose measurement were recorded before each abdominal massage.

Effects of in-bed exercise on gastrointestinal complications

时间窗: About 6 months

The in-bed exercise was repeated for 3 days and the gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status, and blood glucose measurement were recorded in the enteral nutrition follow-up form before each exercise.

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

Zeliha CENGİZ

Principal Investigator

Inonu University

研究点 (2)

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