- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06179238
Urinary Catheter Self-care Management
December 22, 2023 updated by: Filz Ozel Cakir, Kastamonu University
Education Given to Patients With Urinary Catheters on Urinary Catheter Self-care Management and Urinary Tract Infection Impact on Status
It is important for healthcare professionals to be sensitive to the needs of patients undergoing urinary catheterization.
Patients and their relatives should be educated, guided and supported by nurses and other healthcare professionals.
The aim of this study was to determine the effect of education given to patients with urinary catheterization on urinary catheter self-care management and urinary tract infection status. is planned as an experimental research.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The most important risk factor in the development of healthcare-associated infections of the urinary system is the insertion of a urinary catheter.
Because when a urinary catheter is inserted, the possibility of developing daily bacteriuria inthe patient increases.
Urinary catheter application can cause the development of fungal infections as well as bacterial infections in the patient.
Although most of these infections are asymptomatic and do not pose a threat, symptomatic serious infections rarely occur.
may occur.
There is a risk of catheter-associated urinary tract infection in both long and short-term catheterization.
This risk increases as the duration of catheterization increases.
According to the Nursing Regulation published in 2011 in our country, the initiatives in this direction are expected to be continued by nurses.
Therefore, in this study, the knowledge and practices of patients with urinary catheter will be examined and the effect of the education given on urinary catheter self-care management and urinary tract infection status will be evaluated.
It is thought that the results of the study will guide patients with urinary catheters and nurses who provide care about the care and education of patients.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kastamonu, Turkey, 37000
- Kastamonu Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Volunteer to participate in the study
- Urinary catheterization
- Being conscious
- To be able to do self-care
Exclusion Criteria:
- Not volunteering to participate in the study
- Lack of awareness
- Inability to take care of themselves
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patient with urinary catheter receiving patient education
The population of the study consisted of urinary catheterized patients treated in the clinics of a Training and Research Hospital.
G*Power power analysis was used to calculate the number of individuals constituting the sample.
The effect size was set to 0.80, which is a high level according to Cohen for comparing the means of independent samples.
To ensure that the statistical power of the study was above 95%, the sample size was set at a 5% significance level and the effect size was 0.5.
(df = 68; t = 1.668)
The sample size was calculated as 70 patients.
The study is planned to be conducted with 35 patients for each of the two study groups.
|
Patients with urinary catheter insertion during the study periods will be identified and consent will be obtained for the study.
In the first stage of the study, questionnaires will be applied face to face to the experimental group and the control group.
Then, education and brochures will be given to the patients in the experimental group.
Patients in the experimental group will be visited and evaluated every day until the urinary catheter is removed.
After the urinary catheter is removed, the patients in the experimental group and urinary catheter self-care management scale will be applied to the control group.
|
|
Other: Patient with urinary catheter without patient education
The population of the study consisted of urinary catheterized patients treated in the clinics of a Training and Research Hospital.
G*Power power analysis was used to calculate the number of individuals constituting the sample.
The effect size was set to 0.80, which is a high level according to Cohen for comparing the means of independent samples.
To ensure that the statistical power of the study was above 95%, the sample size was set at a 5% significance level and the effect size was 0.5.
(df = 68; t = 1.668)
The sample size was calculated as 70 patients.
The study is planned to be conducted with 35 patients for each of the two study groups.
|
without patient education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Urinary Catheter Self-Care Management Scale
Time Frame: 10 days
|
The Urinary Catheter Self-Care Management Scale consists of a total of 13 items and 4 sub-dimensions.Urinary Catheter Self-Efficacy was funded by the United States National Institute of Nursing Research and developed by Wilde et al. in 2016.
The scale consists of a total of 13 items and 4 subscales.
The sub-dimensions of the scale are related to physician/nurse communication (items: items 7, 8, 9 and 13), avoid restriction of daily activities (items 10, 11 and 12), prevention of catheter dislodgement (items 4, 5 and 6) and self-efficacy/ fluid intake (items 1, 2 and 3).
Scale items are scored on a 10-point Likert scale ranging from 1 = "I am not at all sure that I can do it" to 10 = "I am not at all sure that I can do it".
"I am completely sure that I can do it" and high scores indicate high self-efficacy.
is a good measure of the quality of the study.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2023
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
November 19, 2023
First Submitted That Met QC Criteria
December 20, 2023
First Posted (Actual)
December 21, 2023
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 22, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12345 (Danish Center for Healthcare Improvements)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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