Urinary CatheterNCT06829927
The Effect of E-Booklet Traınıng on Self-Effıcacy and Comfort Level in Patıents Wıth Urınary Catheter
A study testing e-book in people with Urinary Catheter, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Urinary catheterization is the insertion of a tube through the urethra into the bladder to empty or flush the bladder. Catheterization is preferred in patients with urinary retention and urinary incontinence, in patients who will undergo surgical intervention or in cases where a procedure needs to be performed in the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Catheter
- What is being tested?
- e-book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 30 Dec 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who can actively use information technologies such as phones and tablets
- Inpatients in the Urology Clinic
- Conscious and oriented patients
- Patients aged 18-75 years
- Patients with short-term catheterization
- Patients without hearing and communication disabilities
- Literate patients
Who cannot join
- Patients who incompletely completed the data collection tool
- Patients with hearing, vision and comprehension problems,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tokat Gaziosmanpaşa University
Tokat/Merkez, Tokat Province, 6050
Şeyda
About this study
Official title: The Effect of E-Booklet Traınıng Created Wıthın the Scope of Comfort Theory on Self-Effıcacy and Comfort Levels in Patıents Wıth Urınary Catheter: a Randomızed Controlled Study
Urinary catheterization is the insertion of a tube through the urethra into the bladder to empty or flush the bladder. Catheterization is preferred in patients with urinary retention and urinary incontinence, in patients who will undergo surgical intervention or in cases where a procedure needs to be performed in the urinary tract, and is applied for short (1-7 days), medium (7-28 days) and long term (longer than 28 days) (National Institute of Diabetes and Digestive and Kidney Diseases. (2023). Urinary catheterization is frequently preferred in applications related to treatment and care. According to the CAUTI report, the frequency of urinary catheterization in hospitalized patients in one year is between 15-25% in the world. This rate is between 10-15% in developed countries and 20-30% in developing countries (CAUTI, 2015).
Read the detailed description
Urinary catheterization is generally preferred for short-term care and treatment (Clarke et al., 2020; Cutinho et al., 2018). Urinary catheterization is critical in routine health care and can cause many complications such as urinary tract infection, epididymitis, catheter obstruction, trauma, pain, bladder spasm, and hematuria if not used appropriately.Darbyshire et al. (2016) found that 32% of patients experienced leakage, 26% experienced pain, 26% experienced discomfort and 24% experienced obstruction.In fact, it is estimated that 450,000 people in the UK undergo short-term urinary catheterization and complications related to urinary catheter use cause 2100 deaths annually (Feneley et al., 2015).
Although urinary tract infection due to catheterization is common, patients' failure to perform appropriate behaviors and practices related to catheterization causes the infection to progress and the treatment process to be prolonged.Urinary tract infections account for approximately 20% of healthcare-acquired infections in acute care facilities and more than 50% in long-term care facilities (Zegeye et al., 2023). In the United States, urinary tract infections account for 32% of all hospital-acquired infections and are the most common type of hospital-acquired infection, with approximately 449,000 cases of urinary tract infections and an estimated cost of $450 million per year (Abiodun, 2018). In cases where they are not inserted under appropriate conditions, care is not provided effectively and treatment protocols are not followed, they pave the way for the development of resistant microorganisms. Accordingly, urinary tract infection, which requires a long treatment process in patients, causes many negative consequences, including prolonged hospital stay, increased in-hospital mortality and increased health care costs (Anderson et al., 2021; Cutinho et al., 2018; Snyder et al., 2023).
- Conditions
- Urinary Catheter
- Being tested
- e-book
- Keywords
- urinary cathether, comfort, self-efficiaty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-bookBehavioural
Patients with pilot application will not be included in the study. Patients who agree to participate in the study will be informed by the researcher about the purpose and process of the study, and their written and verbal informed consent will be obtained. Patients will be informed that the decision on whether or not to participate in the study is entirely their own, that no money will be deducted from their health insurance or any money will be paid to them, that the data to be collected from this study will only be used within the scope of the research, and that confidentiality will be strictly ensured. Pretests (Personal Information Form, Urinary Catheter Self-Efficacy Scale and Comfort Scale) will be administered to the patients whose consent is obtained.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the control group will not be given any content and their routine care and education will continue. Patients in the control group will be asked to complete the Urinary Catheter Self-Efficacy Scale and Comfort Scale at the 6th and 24 th hours following urinary catheter insertion. |
| intervention group | Active comparator | Patients in the intervention group will be informed about the urinary catheter by the researcher after catheter insertion, and the link to the e-booklet will be given and the patients will be asked to review it. Patients will be asked to fill out the Urinary Catheter Self-Efficacy Scale and Comfort Scale at the 6th and 24th hour following urinary catheter insertion. After the completion of the study, the link to the e-booklet will be given to the patients in the control group to maintain the principle of equality. The research data will be collected by the researcher between 30.09.2024 and 30.10.2025 via Google survey. Receives: Behavioral: e-book |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Follow-up (Personal Information Form, Urinary Catheter Self-Efficacy Scale and Comfort Scale
Pretest (Descriptive statistics will be shown with frequencies and percentages, and the distribution of variables according to scale scores will be shown with median (minimum-maximum) values.
Measured: after catheterization ( First 1 hour)
Secondary outcomes (2)
Second Follow-up (Urinary Catheter Self-Efficacy Scale and Comfort Scale)
Second Follow-up . The conformity of the data to normal distribution will be evaluated by Kolmogrov Smirnow test and Mann-Whitney U and Kruskal-Wallis tests, which are non-parametric tests, will be used to compare variables that do not conform to normal distribution. Normally distributed data will be evaluated with t test and Anova test. In order to determine the differences in variables with more than two groups, the Dunn-Bonferroni test from Post-Hoc tests will be used. The relationship between self-efficacy and comfort level will be determined by Spearman Correlation Coefficient. Significance level p<0.05 will be taken in the tests.
Measured: 6 hours
Third Follow-up(Urinary Catheter Self-Efficacy Scale and Comfort Scale)
Third Follow-up . The conformity of the data to normal distribution will be evaluated by Kolmogrov Smirnow test and Mann-Whitney U and Kruskal-Wallis tests, which are non-parametric tests, will be used to compare variables that do not conform to normal distribution. Normally distributed data will be evaluated with t test and Anova test. In order to determine the differences in variables with more than two groups, the Dunn-Bonferroni test from Post-Hoc tests will be used. The relationship between self-efficacy and comfort level will be determined by Spearman Correlation Coefficient. Significance level p<0.05 will be taken in the tests.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Sep 2024
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CatheterStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a Randomized Controlled Trial to determine urinary catheter-related self-efficacy and comfort levels of patients hospitalized in a university hospital.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- TOGÜ
- Responsible party
- Principal investigator, Şeyda KAZANÇ, Tokat Gaziosmanpasa University
- Investigators
- Hülya Koçyiğit KAVAK, Study chair, Cumhuriyet UniversityŞerife Karagözoğlu, Prof. Dr., Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829927
- Sponsor's protocol ID
- TOGÜ
- Other IDs
- Hülya KOÇYİĞİT KAVAK
- Status last verified
- Sep 2024
- First submitted
- 19 Jul 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of E-Booklet Traınıng Created Wıthın the Scope of Comfort Theory on Self-Effıcacy and Comfort Levels in Patıents Wıth Urınary Catheter: a Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT06829927
- Acronym / sponsor ID
- TOGÜ
- Conditions
- Urinary Catheter
- Keywords
- urinary cathether, comfort, self-efficiaty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- TOGÜ
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
Urinary catheterization is the insertion of a tube through the urethra into the bladder to empty or flush the bladder. Catheterization is preferred in patients with urinary retention and urinary incontinence, in patients who will undergo surgical intervention or in cases where a procedure needs to be performed in the urinary tract, and is applied for short (1-7 days), medium (7-28 days) and long term (longer than 28 days) (National Institute of Diabetes and Digestive and Kidney Diseases. (2023). Urinary catheterization is frequently preferred in applications related to treatment and care. According to the CAUTI report, the frequency of urinary catheterization in hospitalized patients in one year is between 15-25% in the world. This rate is between 10-15% in developed countries and 20-30% in developing countries (CAUTI, 2015).
Detailed description
Urinary catheterization is generally preferred for short-term care and treatment (Clarke et al., 2020; Cutinho et al., 2018). Urinary catheterization is critical in routine health care and can cause many complications such as urinary tract infection, epididymitis, catheter obstruction, trauma, pain, bladder spasm, and hematuria if not used appropriately.Darbyshire et al. (2016) found that 32% of patients experienced leakage, 26% experienced pain, 26% experienced discomfort and 24% experienced obstruction.In fact, it is estimated that 450,000 people in the UK undergo short-term urinary catheterization and complications related to urinary catheter use cause 2100 deaths annually (Feneley et al., 2015).
Although urinary tract infection due to catheterization is common, patients' failure to perform appropriate behaviors and practices related to catheterization causes the infection to progress and the treatment process to be prolonged.Urinary tract infections account for approximately 20% of healthcare-acquired infections in acute care facilities and more than 50% in long-term care facilities (Zegeye et al., 2023). In the United States, urinary tract infections account for 32% of all hospital-acquired infections and are the most common type of hospital-acquired infection, with approximately 449,000 cases of urinary tract infections and an estimated cost of $450 million per year (Abiodun, 2018). In cases where they are not inserted under appropriate conditions, care is not provided effectively and treatment protocols are not followed, they pave the way for the development of resistant microorganisms. Accordingly, urinary tract infection, which requires a long treatment process in patients, causes many negative consequences, including prolonged hospital stay, increased in-hospital mortality and increased health care costs (Anderson et al., 2021; Cutinho et al., 2018; Snyder et al., 2023).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was planned as a Randomized Controlled Trial to determine urinary catheter-related self-efficacy and comfort levels of patients hospitalized in a university hospital.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the control group will not be given any content and their routine care and education will continue. Patients in the control group will be asked to complete the Urinary Catheter Self-Efficacy Scale and Comfort Scale at the 6th and 24 th hours following urinary catheter insertion. |
| intervention group | Active comparator | Behavioral: e-bookPatients in the intervention group will be informed about the urinary catheter by the researcher after catheter insertion, and the link to the e-booklet will be given and the patients will be asked to review it. Patients will be asked to fill out the Urinary Catheter Self-Efficacy Scale and Comfort Scale at the 6th and 24th hour following urinary catheter insertion. After the completion of the study, the link to the e-booklet will be given to the patients in the control group to maintain the principle of equality. The research data will be collected by the researcher between 30.09.2024 and 30.10.2025 via Google survey. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who can actively use information technologies such as phones and tablets
- Inpatients in the Urology Clinic
- Conscious and oriented patients
- Patients aged 18-75 years
- Patients with short-term catheterization
Key exclusion criteria (2 listed)
- Patients who incompletely completed the data collection tool
- Patients with hearing, vision and comprehension problems,
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 |
|---|---|---|
| e-bookPatients with pilot application will not be included in the study. Patients who agree to participate in the study will be informed by the researcher about the purpose and process of the study, and their written and verbal informed consent will be obtained. Patients will be informed that the decision on whether or not to participate in the study is entirely their own, that no money will be deducted from their health insurance or any money will be paid to them, that the data to be collected from this study will only be used within the scope of the research, and that confidentiality will be strictly ensured. Pretests (Personal Information Form, Urinary Catheter Self-Efficacy Scale and Comfort Scale) will be administered to the patients whose consent is obtained. | Behavioural | intervention group |
Primary outcome
First Follow-up (Personal Information Form, Urinary Catheter Self-Efficacy Scale and Comfort Scale
Time frame: after catheterization ( First 1 hour)
Pretest (Descriptive statistics will be shown with frequencies and percentages, and the distribution of variables according to scale scores will be shown with median (minimum-maximum) values.
2 secondary outcomes
Second Follow-up (Urinary Catheter Self-Efficacy Scale and Comfort Scale)
Time frame: 6 hours
Third Follow-up(Urinary Catheter Self-Efficacy Scale and Comfort Scale)
Time frame: 24 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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.
Hülya Koçyiğit KAVAK study chair
Cumhuriyet University
Şerife Karagözoğlu, Prof. Dr. principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-book in people with Urinary Catheter, run by Cumhuriyet 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Feb 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şeyda KAZANÇ, Asst. Prof. (05377782297, orhanseyda@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Follow-up (Personal Information Form, Urinary Catheter Self-Efficacy Scale and Comfort Scale (time frame: after catheterization ( First 1 hour)). 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 17 Feb 2025.