Design and Clinical Application of Colonoscopy Position Identification Sheet

Not Applicable

• Conditions: Disease of Lower Digestive Tract; Nurse-Patient Relations

• 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

Primary Outcome Measures

Name	Time	Method
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
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
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