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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05239481
Other study ID # CPIS-LC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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