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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05334225
Other study ID # 10010
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2022
Source Medipol University
Contact Gökhan Çalik
Phone +90533 934 38 50
Email gcalik@medipol.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rationale: Healthcare professionals regularly perform transurethral catheterization. They may have not sufficient knowledge, experience, and self-confidence about urethral catheterization. This can cause an increased risk of urethral catheterization-related injury and morbidity. With an appropriate training program, we can raise the knowledge and self-confidence of healthcare professionals in performing transurethral catheterization. Primary Objective: To compare knowledge and self-confidence amongst healthcare workers in performing urethral catheterization before and after the proposed urethral catheterization training program. Secondary Objective: To compare the traumatic catheterization rates before and after the proposed urethral catheterization training program. Study design: This study is a prospective multi-center trial using a questionnaire for assessing the healthcare professionals about urethral catheterization knowledge and self-confidence before and after a urethral catheterization training program, where their evaluation is scheduled 6 months after the training. Study population: The study population comprises medical health workers (nurses, paramedics and doctors) from 5 different Medipol Hospitals working at surgical and non-surgical departments. Intervention: An in-person urethral catheterization training program that utilizes training videos (demonstrating procedures, providing examples of ordinary and difficult cases, utilizing animation techniques as well) Main study parameters/endpoints: Primary endpoint is the change in self-reported self-confidence and knowledge in urethral catheterization following the training. The secondary endpoint is the change in complicated/traumatic urethral catheterization following the training. A complicated/traumatic catheterization is defined as a urethral catheterization requiring the intervention of a urologist.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: Healthcare workers (paramedics, nurses, and doctors) working in the emergency department, intensive care, operating rooms, departments of gynecology, general surgery, urology, orthopedics, neurology, internal medicine, cardiology, and anesthesiology - Exclusion Criteria: Healthcare workers that not working non-clinic services, -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Training Program
An in-person urethral catheterization training program that utilizes training videos (demonstrating procedures, providing examples of ordinary and difficult cases, utilizing animation techniques as well)

Locations

Country Name City State
Turkey Medipol Mega University Hospital Istanbul Bagcilar

Sponsors (2)

Lead Sponsor Collaborator
Betül Kartal Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Studying The Reason For Traumatic Catheterization Through Surveys Evaluating the reason why traumatic catheterization happens (lack of experience, stress, challenging case, wrong equipment, etc.) through surveys prepared for health care workers that are involved in catheterization process. 1 year
Primary Reducing The Traumatic Catheterization Case Number Through The Training and Comparison Surveys After the initial survey results, health care workers will go through a special training period for relearning correct catheterization methods. After the training, case numbers will be compared to before the training period and same survey will be distributed again to health care workers to compare their initial and final survey results. 1 year
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