Investigation of the Effect of Abdominal Massage on Patients in Intensive Care Unit: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- Incidence of Sepsis During Follow-Up
研究概览
简要总结
Bowel motility can be affected by many factors such as immobilization, lack of fiber in the nutritional formula, inadequate fluid intake, and lack of privacy for toileting in patients hospitalized in the intensive care unit. Abdominal massage, which is one of the effective methods to increase intestinal motility, is accepted as an intervention that can be safely applied in patients.
The aim of our study was to investigate the effect of abdominal massage applied to patients hospitalized in the intensive care unit on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use.
Hypotheses H0: Abdominal massage application has no effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit.
H1: Abdominal massage application has an effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit.
In this randomized controlled study, the data of patients who received abdominal massage for 5 days during routine physiotherapy applications and those who did not will be recorded. Randomization will be performed in a 1:1 ratio using a computer generated randomization schedule. The effect of abdominal massage on sepsis, survival, discharge time from intensive care, amount and duration of antibiotic use will be examined by using the data of 2 groups with and without abdominal massage in a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 to 80 years
- •Patients hospitalized in the intensive care unit for more than 3 days
- •Body Mass Index less than 30 kg/m²
- •Patients who are not mobilized out of bed
- •Patients without any intervention contraindicating abdominal massage
排除标准
- •History of abdominal surgery
- •Active gastrointestinal bleeding
- •Patients discharged from ICU within less than 5 days after enrollment
研究组 & 干预措施
Abdominal Massage Group
In addition to routine physiotherapy, patients will receive abdominal massage daily for 5 days.
干预措施: abdominal massage (Other)
Control Group
Routine physiotherapy will be continued for patients in this group.
结局指标
主要结局
Incidence of Sepsis During Follow-Up
时间窗: From ICU admission through Day 5 of follow-up
Sepsis will be assessed and recorded according to the Sepsis-3 definition, which requires the presence of suspected or confirmed infection and an acute increase in SOFA (Sequential Organ Failure Assessment) score of ≥2 points from baseline. Data for sepsis diagnosis will be collected from daily clinical evaluations, vital signs, laboratory parameters (white blood cell count, procalcitonin, CRP, blood cultures), and organ function assessments. All assessments will be performed by ICU physicians and verified using electronic medical records.
Survival Rate During Follow-Up
时间窗: From ICU admission through Day 5 of follow-up
Survival will be assessed by recording the number of patients who remain alive from ICU admission until the end of the 5-day follow-up period.
Length of ICU Stay
时间窗: From ICU admission through Day 5 of follow-up
Length of stay in the intensive care unit will be measured in days, calculated as the number of days between the date of ICU admission and the date of ICU discharge. Information will be extracted from patient medical records.
Duration of Antibiotic Use
时间窗: From ICU admission through Day 5 of follow-up, recorde in days
The total number of days each patient receives antibiotic treatment will be recorded during the 5-day follow-up period in the ICU. Data will be collected from medication administration records in the patient's medical file.
Amount of Antibiotic Consumption
时间窗: From ICU admission through Day 5 of follow-up, recorded in milligrams (mg)
The cumulative amount of antibiotics administered to each patient during the 5-day follow-up period will be recorded in milligrams (mg). Data will be obtained from electronic medication administration records in the ICU.
次要结局
未报告次要终点
研究者
A. Oguzhan KUCUK
MD
Karadeniz Technical University