Design and Clinical Application of Colonoscopy Position Identification Sheet

NCT ID: NCT05239481

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-06-30

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.

Conditions

Disease of Lower Digestive Tract; Nurse-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intervention

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.

Group Type: EXPERIMENTAL

colonoscopy position identification sheet

Intervention Type: DEVICE

According to the body position requirements of the left lying position during colonoscopy, the research group used ink to add the body position prompt sign on the disposable bed sheet .Through the position identification, patients can intuitively understand the position that should be used in the operation and the position that should be placed in each part of the body.

control

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.

Group Type: PLACEBO_COMPARATOR

Traditional disposable cleaning sheet

Intervention Type: DEVICE

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.

Interventions

colonoscopy position identification sheet

According to the body position requirements of the left lying position during colonoscopy, the research group used ink to add the body position prompt sign on the disposable bed sheet .Through the position identification, patients can intuitively understand the position that should be used in the operation and the position that should be placed in each part of the body.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

Chief of gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Zhao S, Yang X, Wang S, Meng Q, Wang R, Bo L, Chang X, Pan P, Xia T, Yang F, Yao J, Zheng J, Sheng J, Zhao X, Tang S, Wang Y, Wang Y, Gong A, Chen W, Shen J, Zhu X, Wang S, Yan C, Yang Y, Zhu Y, Ma RJ, Wang R, Ma Y, Li Z, Bai Y. Impact of 9-Minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e168-e181. doi: 10.1016/j.cgh.2020.11.019. Epub 2020 Nov 19.

Reference Type: BACKGROUND

PMID: 33220526 (View on PubMed)

Other Identifiers

CPIS-LC

Identifier Type: -

Identifier Source: org_study_id