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Design and Clinical Application of Colonoscopy Position Identification Sheet

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05239481
Enrollment
1100
Registered
2022-02-15
Start date
2022-03-01
Completion date
2022-06-30
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease of Lower Digestive Tract, Nurse-Patient Relations

Keywords

colonoscopy; body position identification; bed sheet

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.

Interventions

DEVICEcolonoscopy 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.

DEVICETraditional 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.

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
One-time success rate of body position placement30 minutesRefers to the proportion of the number of patients in the total study cases that can be accurately placed by the nurse
The time required for the nurse to guide it to complete the body position placement30 minutesThe timing begins when the nurse began posture education, Until the patient correctly puts the required body position timing stops
Time for nurses to conduct physical position education30 minutesRefers to the length of the nurse to guide the completion of the body placement

Secondary

MeasureTime frameDescription
Satisfaction of doctors, nurses and patients5 minutesScoring was performed using a visual simulation scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026