Design and Clinical Application of Colonoscopy Position Identification Sheet

Not Applicable

• Conditions: Disease of Lower Digestive Tract; Nurse-Patient Relations
• Interventions: Device: colonoscopy position identification sheet; Device: Traditional disposable cleaning sheet

• Registration Number: NCT05239481
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-30
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15
• Study Start: 2022-03-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	colonoscopy position identification sheet	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.
control	Traditional disposable cleaning sheet	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.

Primary Outcome Measures

Name	Time	Method
One-time success rate of body position placement	30 minutes	Refers to the proportion of the number of patients in the total study cases that can be accurately placed by the nurse
Time for nurses to conduct physical position education	30 minutes	Refers to the length of the nurse to guide the completion of the body placement
The time required for the nurse to guide it to complete the body position placement	30 minutes	The timing begins when the nurse began posture education, Until the patient correctly puts the required body position timing stops

Secondary Outcome Measures

Name	Time	Method
Satisfaction of doctors, nurses and patients	5 minutes	Scoring was performed using a visual simulation scale