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Design and Clinical Application of Colonoscopy Position Identification Sheet

N

Naval Military Medical University

Status

Unknown

Conditions

Disease of Lower Digestive Tract
Nurse-Patient Relations

Treatments

Device: colonoscopy position identification sheet
Device: Traditional disposable cleaning sheet

Study type

Interventional

Funder types

Other

Identifiers

NCT05239481
CPIS-LC

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,100 participants in 2 patient groups, including a placebo group

intervention
Experimental group
Description:
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.
Treatment:
Device: colonoscopy position identification sheet
control
Placebo Comparator group
Description:
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.
Treatment:
Device: Traditional disposable cleaning sheet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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