Chronic DiseasesNCT06179238
Urinary Catheter Self-care Management
A study testing Education and without patient education in people with Chronic Diseases, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- Education and without patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Volunteer to participate in the study
- Urinary catheterization
- Being conscious
- To be able to do self-care
Who cannot join
- Not volunteering to participate in the study
- Lack of awareness
- Inability to take care of themselves
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu Training and Research Hospital
Kastamonu, 37000
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Diseases
- Being tested
- Education, without patient education
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
without patient educationOther
without patient education
| Study group | Role | What they receive |
|---|---|---|
| Patient with urinary catheter receiving patient education | Other | 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. Receives: Other: Education |
| Patient with urinary catheter without patient education | Other | 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. Receives: Other: without patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Urinary Catheter Self-Care Management Scale
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start30 Jul 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filz Ozel Cakir, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179238
- Sponsor's protocol ID
- 12345
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Given to Patients With Urinary Catheters on Urinary Catheter Self-care Management and Urinary Tract Infection Impact on Status
- ClinicalTrials.gov ID
- NCT06179238
- Acronym / sponsor ID
- 12345
- Conditions
- Chronic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with urinary catheter receiving patient education | Other | Other: EducationThe 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. |
| Patient with urinary catheter without patient education | Other | Other: without patient educationThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer to participate in the study
- Urinary catheterization
- Being conscious
- To be able to do self-care
Key exclusion criteria (3 listed)
- Not volunteering to participate in the study
- Lack of awareness
- Inability to take care of themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationPatients 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 receiving patient education |
| without patient educationwithout patient education | Other | Patient with urinary catheter without patient education |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and without patient education in people with Chronic Diseases, run by Kastamonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Urinary Catheter Self-Care Management Scale (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.