Design and Clinical Application of Colonoscopy Position Identification Sheet

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nurse-Patient Relations; Disease of Lower Digestive Tract
• Intervention / Treatment: Device: colonoscopy position identification sheet; Device: Traditional disposable cleaning sheet

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 Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.
PLACEBO_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of doctors, nurses and patients	Scoring was performed using a visual simulation scale	5 minutes

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): May 30, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (ACTUAL): February 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: colonoscopy; body position identification; bed sheet
• Other Study ID Numbers: CPIS-LC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No