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临床试验/NCT05239481
NCT05239481Unknown不适用

Design and Clinical Application of Colonoscopy Position Identification Sheet: a Prospective, Multicenter, Randomized Controlled Study

Changhai Hospital0 个研究点目标入组 1,100 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,100
主要终点
Time for nurses to conduct physical position education

研究概览

简要总结

Before colonoscopy, the nursing staff need to educate the patient with posture coordination.However, it is difficult for some patients to understand the placement of the correct body position, which takes too much time to conduct repeated education, which wastes medical resources, reduces work efficiency, and even causes conflicts between doctors and patients.In this study, the colonoscopy position identification sheet with indicator function was designed to assist the position placement of patients. Preliminary experiments of small samples have achieved good clinical results. Now, multicenter, randomized controlled research is carried out to further verify the clinical application effect.

详细描述

This study was a prospective, multicenter, randomized controlled study involving patients who first underwent colonoscopy in 11 centers in China. Patients were randomly divided into two groups: the experimental group used colonoscopy position identification sheet, and the control group used ordinary clean sheets. The main evaluation index was the time required from the nurse guide to the patient complete the position placement, and the secondary indicators were doctors' satisfaction, nurse satisfaction and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •between 18 and 65 and signed informed consent
  • •with first colonoscopy
  • •with complete self-care (ADL 100)

排除标准

  • •patients with emergency colonoscopy
  • •communication or cognitive impairment
  • •patients requiring endoscopic intervention

研究组 & 干预措施

intervention

Experimental

Before the examination, the nurse chose the appropriate colonoscopy position size sheet according to the patient's age and body size and spread it on the examination bed; instructed the patient to lie in the designated area according to the body size.Description: ① take off your shoes; ② follow the bed chart; ③ fade your pants to your knees.

干预措施: colonoscopy position identification sheet (Device)

control

Placebo Comparator

Traditional disposable cleaning sheets were used during control colonoscopy.Before the examination, the nursing staff took a unified and simple language to guide the patient, the following: ① please remove the shoes; ② please sit on the end of the bed mattress; ③ please lie to the left side; ④ please put the head close to the pillow; ⑤ please fade the pants to the knee; ⑥ please put the knee close to the abdomen.

干预措施: Traditional disposable cleaning sheet (Device)

结局指标

主要结局

Time for nurses to conduct physical position education

时间窗: 30 minutes

Refers to the length of the nurse to guide the completion of the body placement

One-time success rate of body position placement

时间窗: 30 minutes

Refers to the proportion of the number of patients in the total study cases that can be accurately placed by the nurse

The time required for the nurse to guide it to complete the body position placement

时间窗: 30 minutes

The timing begins when the nurse began posture education, Until the patient correctly puts the required body position timing stops

次要结局

  • Satisfaction of doctors, nurses and patients(5 minutes)

研究者

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

Zhaoshen Li

Chief of gastroenterology

Changhai Hospital

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