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临床试验/NCT05310825
NCT05310825已完成不适用

An Examination of the Effect on Various Factors of Bed Baths Applied by Two Different Methods in Intensive Care Patients

Uludag University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年5月17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
22
试验地点
2
主要终点
Primary Outcome Measure

研究概览

简要总结

The aim of this study is to evaluate the effect on various hemodynamic factors (breathing, pulse, blood pressure, peripheral oxygen saturation) of patients in intensive care units and the time taken for the procedure of a traditional wiping bed bath performed with soap and water) and one performed with single-use wipes.

The research is planned as a randomized, controlled, crossover and experimental study. Because it is planned as a crossover study, patients will be in both the experimental and the control group. The research will be conducted in the General Surgery Intensive Care Unit of Bursa Uludağ University Health Applications Research Center, Turkey. The population of the study will consist of patients in the Intensive Care Unit.

Patients participating in the study will be given two types of wiping body bath. One of these will be a wiping body bath performed with soap and water, which is accepted as a traditional bed bath. The other will be a body wiping bath performed with single-use wipes, which is accepted as a dry bath. All bathing procedures in the study will be conducted by the same researcher.

During both types of bathing, an assistant patient care worker will help the researcher in the process of turning the patient. Before starting, this assistant will be given information on the steps in bed bathing by the researcher. Each patient will be given a traditional wiping bed bath and a dry wiping bath with single-use wipes. Because this is a crossover study, the patient will be part of both the experimental and the control group.

The patient's first bath will be within the first 24 hours of entry to the intensive care unit. The randomization of each patient's bathing will be carried out according to a randomization list created on a computer and the patients will be assigned to the study groups by the randomization method. In this way, patients will be assigned to group 1 (traditional body wipe bathing with soap and water) and group 2 (dry body wipe bathing with single-use wipes). The bathing order will be carried out according to the randomization for each patient, and in this way, the patient's first bath will be performed as dry body wipe bathing with single-use wipes or as traditional body wipe bathing with soap and water. For each bath, a minimum interval of 24 hours (washing) will be left to prevent one intervention from affecting the other.

Immediately before giving each type of bed bath, every five minutes during the bathing procedure, immediately after finishing the bathing procedure and 30 minutes after finishing the bathing procedure, the patient's pulse, blood pressure, body temperature, breathing rate and oxygen saturation will be measured by a different nurse, and the values obtained together with the time taken for the procedure will be entered on the Patient Bathing Monitoring Form.

The steps to be followed in the wiping procedures of both baths will be, in order, cleaning the patient's face area (the eyes will only be cleaned with rinsing water), the ears on each side, the arms, the hands, the breast and chest area, the legs on each side, the feet, the back, and finally, the perineum and anal area, after which the washing procedure will be terminated.

After bathing, the patient's bedsheets and clothing will be changed and waste will be removed from the area. If the bandaging in the patient's operation area has not yet been removed, the operation area will not be washed. Also, the chronometer will be stopped by a nurse who is independent of the study immediately after the bathing procedure is completed, and the time taken for the procedure will be entered on the form.

详细描述

The aim of this study is to evaluate the effect on various hemodynamic factors (breathing, pulse, blood pressure, peripheral oxygen saturation) of patients in intensive care units and the time taken for the procedure of a traditional wiping bed bath performed with soap and water) and one performed with single-use wipes.

The research is planned as a randomized, controlled, crossover and experimental study. Because it is planned as a crossover study, patients will be in both the experimental and the control group. The research will be conducted in the General Surgery Intensive Care Unit of Bursa Uludağ University Health Applications Research Center. The population of the study will consist of patients in the Intensive Care Unit. The size of the study sample was statistically determined with the program G*Power 3.1.7. In the power analysis conducted to determine the sample size, the two bathing methods were compared, and the effect size of blood pressure and breathing rate was determined. For a significance level of 0.05 and 80% power, it was calculated that a total of 22 patients were needed.

Patients with serious burns and/or diarrhea, open wound bandaging or amputations of the upper or lower extremities, those whose blood pressure measurements cannot be taken because of plaster or for other reasons, those who are discharged or die during data collection, and those who do not agree to participate in the study will not be included in the research.

A Patient Description Form and a Patient Bathing Monitoring Form will be used to obtain data.

Patient Description Form: This from will have questions on patients' age, gender, marital status, education level, medical diagnosis, length of time in hospital and in intensive care, chronic illnesses if any are present, method of connection to ventilation, and sedation status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

盲法说明

The intervention and measurements were carried out by the first researcher.

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

  • Age 18 and over,
  • Having upper and lower extremities,
  • Good capillary filling,
  • Systolic blood pressure is between 90-150 mmHg,
  • SaO2 value of 90% and above,
  • Willing to participate in the research

排除标准

  • Serious burns and/or diarrhea
  • Open wound bandaging or amputations of the upper or lower extremities
  • Discharged or die during data collection
  • Do not agree to participate in the study will not be included in the research

结局指标

主要结局

Primary Outcome Measure

时间窗: 5 months

heart rate in minute

次要结局

  • Secondary Outcome Measure(5 months)

研究者

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

Dilek Yilmaz, PhD

Bursa Uludag University, Department of Nursing

Uludag University

研究点 (2)

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