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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Education
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.
Other: without patient education
without patient education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kastamonu University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12345 (Other Grant/Funding Number: Reasons for Hope Fund in Prevention and Early Detection of Mental Illness)

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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