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临床试验/NCT07327671
NCT07327671已完成不适用

Developing and Efficiency Evaluation of a Positioning Assist Device for Urinary Catheterization in Female Patients

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月27日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Urinary Catheterization Procedure Time (minutes)

研究概览

简要总结

In female patients, the dorsal recumbent position is required to visualize the urethral meatus. In female patients, direct visualization of the urethral meatus after providing a suitable position is very important for successful catheter advancement while maintaining sterile conditions. Especially in unconscious or uncooperative female patients, it is much more difficult to maintain and maintain an appropriate position, and more than one staff may be needed for this. Although it is clear that it is important and difficult to position female patients during catheterization and maintain it throughout the procedure, no device used to assist positioning has been encountered. Therefore, in this project; The aim of this study is to provide a comfortable and safe position for the patient in urinary catheterization in female patients, to develop an auxiliary device to maintain this position throughout the procedure, and to evaluate the effectiveness of this device.

详细描述

Urinary elimination is one of the most fundamental physiological needs, and when it cannot be met by the individual for any reason, urinary catheterisation is required to drain urine accumulated in the bladder. Urinary catheterisation consists of a series of sequential steps. The first step is positioning the patient. In female patients, the dorsal recumbent position is required to visualise the urethral meatus. Once an appropriate position has been achieved in female patients, direct visualisation of the urethral meatus is crucial for the successful advancement of the catheter under sterile conditions. Providing and maintaining an appropriate position is particularly difficult in unconscious or uncooperative female patients, and may require multiple personnel. Although it is clear that positioning female patients during catheterisation and maintaining this position throughout the procedure is important and difficult, no devices have been found to assist with positioning. Therefore, this project aims to develop an assistive device to provide female patients with a comfortable and safe position during urinary catheterisation and to maintain this position throughout the procedure, and to evaluate the effectiveness of this device. To this end, a new positioning cushion will be developed, and a preclinical validation study will be conducted using a mixed-methods research design that includes a randomised controlled trial and a descriptive qualitative study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a nurse with at least a bachelor's degree
  • Previous experience of urinary catheterization
  • Having worked or working in intensive care
  • Having voluntarily agreed to participate in the research

排除标准

  • Leaving work voluntarily

研究组 & 干预措施

dorsal recumbent positioning device

Experimental

procedure performed with dorsal recumbent positioning device

干预措施: dorsal recumbent positioning device (Device)

Control group

No Intervention

结局指标

主要结局

Urinary Catheterization Procedure Time (minutes)

时间窗: From the start to the end of the catheterisation procedure, a maximum of 10 minutes

Total time required to complete the urinary catheterization procedure, measured in minutes from video recordings, including preparation time, catheter insertion time, and total procedure duration.

Nurses' Lumbar Fatigue (Visual Analog Scale, VAS 0-100)

时间窗: Day 1

Lower back fatigue experienced by nurses during the procedure, assessed using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater fatigue.

Need for Support Personnel

时间窗: Day 1

Requirement for additional support staff during the procedure, recorded as yes/no based on video analysis.

Nurses' Physical Effort (Visual Analog Scale, VAS 0-100)

时间窗: Day 1

Physical effort perceived by nurses during the catheterization procedure, measured using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater physical effort.

次要结局

  • User Satisfaction (QUEST 2.0)(Day 1)

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bircan Kolcak

Principal Investigator

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (1)

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