Design and Clinical Application of Colonoscopy Position Identification Sheet

Nurse-Patient Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05239481
• Other study ID #: CPIS-LC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nurse-Patient Relations

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Satisfaction of doctors, nurses and patients	Scoring was performed using a visual simulation scale	5 minutes