Clinical trial NCT05239481: Design and Clinical Application of Colonoscopy Position Identification Sheet
Official title: Design and Clinical Application of Colonoscopy Position Identification Sheet: a Prospective, Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disease of Lower Digestive Tract
Nurse-Patient Relations
Keywords: colonoscopy; body position identification; bed sheet
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: One-time success rate of body position placement
timeFrame: 30 minutes
measure: The time required for the nurse to guide it to complete the body position placement
timeFrame: 30 minutes
measure: Time for nurses to conduct physical position education
timeFrame: 30 minutes
Secondary outcomes:
measure: Satisfaction of doctors, nurses and patients
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: 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.