Catheter Associated Urinary Tract InfectionCAUTINCT07172750
The Effect of Education on Patients' Attitudes and Anxiety Towards CAUTI Prevention
A study testing Education on Urinary Catheter Care in people with Catheter Associated Urinary Tract Infection and Indwelling Urinary Catheter, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out determine the effect of education given to patients after urological surgery on their attitudes and anxiety levels towards preventing catheter-related urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Catheter Associated Urinary Tract Infection, Indwelling Urinary Catheter, Urologic Surgery
- What is being tested?
- Education on Urinary Catheter Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over,
- Male patients,
- Discharged with a urinary catheter after TURP, HOLEP, Internal Urethrotomy, and Open Prostatectomy surgeries at the urology department of the University Hospital where the study will be conducted,
- Possess the cognitive, affective, and psychomotor skills to perform self-care (no coordination problems affecting the upper extremities),
- Are literate,
- Have no visual or auditory communication problems,
- Have no previous psychiatric disorder/diagnosis and are not currently taking medication for psychiatric disorders,
- Individuals who volunteer to participate in the study will be included.
Who cannot join
- Patients who are under 18 years of age,
- Female patients,
- Patients who have undergone surgeries other than TUR-P, HOLEP, Internal Urethrotomy, and Open Prostatectomy,
- Patients with an oncological diagnosis and ongoing care/treatment, or who have previously received oncological treatment,
- Patients who develop postoperative complications/whose general health deteriorates, who do not wish to participate in the study, or who wish to withdraw/exit from any aspect of the study will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aylin ÖZAKGÜL contact
Turkey (Türkiye)1 site
İstanbul University-Cerrahpasa
Istanbul, Istanbul
Kübra ATA, 05398417871
About this study
Official title: The Effect of Education on Patients' Attitudes Towards Preventing Catheter-Associated Urinary Tract Infections and Anxiety After Urologic Surgery
This research will be carried out determine the effect of education given to patients after urological surgery on their attitudes and anxiety levels towards preventing catheter-related urinary tract infections.
Read the detailed description
Urology surgeries are surgical procedures performed to treat diseases of the kidneys, ureters, bladder, prostate, and urethra. Urinary catheterization is a procedure performed to drain urine from the bladder or collect a urine sample using a catheter. A urinary catheter is inserted in 15-25% of hospitalized patients during their hospital stay, and many patients are discharged home with a urinary catheter after urology surgery.
Urinary tract infection (UTI) is the most common healthcare-associated infection, accounting for 36% of all healthcare-associated infections.
Approximately 75% of hospital-acquired urinary tract infections are associated with urinary catheters. A catheter-associated urinary tract infection is defined as a urinary tract infection that occurs when a urinary catheter has been in place for at least two days. Patients discharged with a urinary catheter; They may encounter various problems, including urinary tract infections, bag emptying, catheter changes, clothing adjustments, (hand) hygiene, odor, and catheter kinking. They may also experience physical and psychosocial difficulties related to catheter care. These problems also bring with them the risk of urinary catheter-related complications. Today, nursing practice prioritizes supporting individuals and families in their own self-care by providing them with the necessary knowledge and skills, rather than assuming full responsibility for their care.
Guidelines for preventing catheter-associated urinary tract infections recommend involving patients and their families in their care to prevent these infections.Therefore, nurses, in their role as educators, should provide training to ensure patients maintain their daily activities with their catheters, particularly regarding catheter care.
In this direction, this study will attempt to reveal the effects of post-urological surgery education on patients' attitudes and anxiety levels towards preventing catheter-related urinary tract infections.
This research will be conducted in a prospective, randomized experimental design with pretest-posttest experimental and control groups. The sample size of the study will consist of urology patients who meet the inclusion criteria and agree to participate in the study.The patients to be included in the sample of the study will be randomly divided into two groups as experimental and control groups. The study sample size was calculated using data from a similar study in the literature using the G*Power 3.1.9.7 program for an independent samples t-test, with a test power (power) of 0.80, a confidence level of 95% (1-α), and an effect size of f=0.64, for a total of 62 patients (31 in the experimental group and 31 in the control group), with a minimum of 31 patients in each group.
However, considering data loss, the plan is to include at least 70 patients (35 in the experimental group and 35 in the control group).
Data will be collected using the "Individual Characteristics Form," the "State and Trait Anxiety Inventory," and the "Attitude Scale for Preventing Catheter-Associated Urinary Tract Infections in Patients with Indwelling Urinary Catheters." The "Patient Education Material Evaluation Tool (HEMDA)" will be used to evaluate the educational materials and will be submitted to an expert for review. R ver. 2.15.3 program (R Core Team, 2013) will be used for statistical analysis.
- Conditions
- Catheter Associated Urinary Tract Infection, Indwelling Urinary Catheter, Urologic Surgery
- Being tested
- Education on Urinary Catheter Care
- Keywords
- Catheter associated urinary tract infection, Anxiety, self-care, Urologic Surgery, patient education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on Urinary Catheter CareOther
Urinary catheter care training based on the Roper, Logan, and Tierney Lifestyle Model was developed based on daily living activities.
A training booklet was created based on 11 daily living activities (providing and maintaining a safe environment, communication, breathing, nutrition, etc.).
To increase the effectiveness of the training, a booklet based on this model will be prepared and used as a guide in the training program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group: Urinary catheter care training | Experimental | Urology patients in this group will receive urinary catheter care training based on Roper, Logan, Tierney Model of Nursing (based on Activities of Living). Receives: Other: Education on Urinary Catheter Care |
| No Intervention: Control Group: Standard discharge training | No intervention | Urology patients in this group will not receive any training other than the discharge training routinely applied in the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAUTI Prevention Attitude
The scale developed by Koçyiğit Kavak et al. (2024) is a 31-item instrument designed to assess patients' attitudes towards preventing catheter-associated urinary tract infections. The Turkish validity and reliability study of the scale was conducted by Koçyiğit Kavak et al. in 2024. The Cronbach's alpha coefficient of the scale was reported as 0.882. The scale consists of 31 items in a five-point Likert type format, with response options ranging from "Never = 1," "Rarely = 2," "Sometimes = 3," "Often = 4," to "Always = 5." The minimum possible score is 31, and the maximum score is 155. Higher scores indicate more positive patient attitudes towards preventing catheter-associated urinary tract infections.
Measured: Time Frame: "Baseline (discharge planning day)" Time Frame: "Day of catheter removal (within 3-7 days after discharge)
Anxiety
To determine individuals' anxiety levels, the State-Trait Anxiety Inventory (STAI) will be used. The scale consists of a total of 40 items and is a four-point Likert-type instrument composed of two subscales: the State Anxiety Inventory (first 20 items) and the Trait Anxiety Inventory (last 20 items). The State Anxiety subscale measures how an individual feels at a particular time and under specific conditions, whereas the Trait Anxiety subscale assesses how an individual generally feels regardless of the situation and conditions. A score between 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.
Measured: Time Frame: "Baseline (discharge planning day)" Time Frame: "Day of catheter removal (within 3-7 days after discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Catheter Associated Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra ATA, Istanbul University - Cerrahpasa
- Investigators
- Aylin ÖZAKGÜL, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172750
- Sponsor's protocol ID
- IstanbulUC-KATA
- Acronym
- CAUTI
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is conducted as part of a master thesis, and the collected data will be used only for the purposes of the study and related publications
Publications
Safdar N, Codispoti N, Purvis S, Knobloch MJ. Patient perspectives on indwelling urinary catheter use in the hospital. Am J Infect Control. 2016 Mar 1;44(3):e23-4. doi: 10.1016/j.ajic.2015.10.011. Epub 2015 Dec 14.
PubMed 26698670Inman DM, Jacobson TM, Maxson PM, Wang H, Lohse CM. Effects of urinary catheter education for patients undergoing prostatectomy. Urol Nurs. 2013 Nov-Dec;33(6):289-98.
PubMed 24592522Drake MJ, Clavica F, Murphy C, Fader MJ. Innovating Indwelling Catheter Design to Counteract Urinary Tract Infection. Eur Urol Focus. 2024 Sep;10(5):713-719. doi: 10.1016/j.euf.2024.09.015. Epub 2024 Sep 28.
PubMed 39341718Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.
PubMed 19631064Laan BJ, Nieuwkerk PT, Geerlings SE. Patients knowledge and experience with urinary and peripheral intravenous catheters. World J Urol. 2020 Jan;38(1):57-62. doi: 10.1007/s00345-018-02623-4. Epub 2019 Jan 24.
PubMed 30680418Garcia DM, Makic MBF, Casey K. Rounding and Quick Access Education to Reduce Catheter-Associated Urinary Tract Infections. Clin Nurse Spec. 2023 May-Jun 01;37(3):117-123. doi: 10.1097/NUR.0000000000000741.
PubMed 37058702Parker V, Giles M, Graham L, Suthers B, Watts W, O'Brien T, Searles A. Avoiding inappropriate urinary catheter use and catheter-associated urinary tract infection (CAUTI): a pre-post control intervention study. BMC Health Serv Res. 2017 May 2;17(1):314. doi: 10.1186/s12913-017-2268-2.
PubMed 28464815
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education on Patients' Attitudes Towards Preventing Catheter-Associated Urinary Tract Infections and Anxiety After Urologic Surgery
- ClinicalTrials.gov ID
- NCT07172750
- Acronym / sponsor ID
- CAUTI / IstanbulUC-KATA
- Conditions
- Catheter Associated Urinary Tract Infection, Indwelling Urinary Catheter, Urologic Surgery
- Keywords
- Catheter associated urinary tract infection, Anxiety, self-care, Urologic Surgery, patient education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 15 Sep 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.
This research will be carried out determine the effect of education given to patients after urological surgery on their attitudes and anxiety levels towards preventing catheter-related urinary tract infections.
Detailed description
Urology surgeries are surgical procedures performed to treat diseases of the kidneys, ureters, bladder, prostate, and urethra. Urinary catheterization is a procedure performed to drain urine from the bladder or collect a urine sample using a catheter. A urinary catheter is inserted in 15-25% of hospitalized patients during their hospital stay, and many patients are discharged home with a urinary catheter after urology surgery.
Urinary tract infection (UTI) is the most common healthcare-associated infection, accounting for 36% of all healthcare-associated infections.
Approximately 75% of hospital-acquired urinary tract infections are associated with urinary catheters. A catheter-associated urinary tract infection is defined as a urinary tract infection that occurs when a urinary catheter has been in place for at least two days. Patients discharged with a urinary catheter; They may encounter various problems, including urinary tract infections, bag emptying, catheter changes, clothing adjustments, (hand) hygiene, odor, and catheter kinking. They may also experience physical and psychosocial difficulties related to catheter care. These problems also bring with them the risk of urinary catheter-related complications. Today, nursing practice prioritizes supporting individuals and families in their own self-care by providing them with the necessary knowledge and skills, rather than assuming full responsibility for their care.
Guidelines for preventing catheter-associated urinary tract infections recommend involving patients and their families in their care to prevent these infections.Therefore, nurses, in their role as educators, should provide training to ensure patients maintain their daily activities with their catheters, particularly regarding catheter care.
In this direction, this study will attempt to reveal the effects of post-urological surgery education on patients' attitudes and anxiety levels towards preventing catheter-related urinary tract infections.
This research will be conducted in a prospective, randomized experimental design with pretest-posttest experimental and control groups. The sample size of the study will consist of urology patients who meet the inclusion criteria and agree to participate in the study.The patients to be included in the sample of the study will be randomly divided into two groups as experimental and control groups. The study sample size was calculated using data from a similar study in the literature using the G*Power 3.1.9.7 program for an independent samples t-test, with a test power (power) of 0.80, a confidence level of 95% (1-α), and an effect size of f=0.64, for a total of 62 patients (31 in the experimental group and 31 in the control group), with a minimum of 31 patients in each group.
However, considering data loss, the plan is to include at least 70 patients (35 in the experimental group and 35 in the control group).
Data will be collected using the "Individual Characteristics Form," the "State and Trait Anxiety Inventory," and the "Attitude Scale for Preventing Catheter-Associated Urinary Tract Infections in Patients with Indwelling Urinary Catheters." The "Patient Education Material Evaluation Tool (HEMDA)" will be used to evaluate the educational materials and will be submitted to an expert for review. R ver. 2.15.3 program (R Core Team, 2013) will be used for statistical analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group: Urinary catheter care training | Experimental | Other: Education on Urinary Catheter CareUrology patients in this group will receive urinary catheter care training based on Roper, Logan, Tierney Model of Nursing (based on Activities of Living). |
| No Intervention: Control Group: Standard discharge training | No intervention | –Urology patients in this group will not receive any training other than the discharge training routinely applied in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 and over,
- Male patients,
- Discharged with a urinary catheter after TURP, HOLEP, Internal Urethrotomy, and Open Prostatectomy surgeries at the urology department of the University Hospital where the study will be conducted,
- Possess the cognitive, affective, and psychomotor skills to perform self-care (no coordination problems affecting the upper extremities),
- Are literate,
Key exclusion criteria (5 listed)
- Patients who are under 18 years of age,
- Female patients,
- Patients who have undergone surgeries other than TUR-P, HOLEP, Internal Urethrotomy, and Open Prostatectomy,
- Patients with an oncological diagnosis and ongoing care/treatment, or who have previously received oncological treatment,
- Patients who develop postoperative complications/whose general health deteriorates, who do not wish to participate in the study, or who wish to withdraw/exit from any aspect of the study will not be included in the study.
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 |
|---|---|---|
| Education on Urinary Catheter CareUrinary catheter care training based on the Roper, Logan, and Tierney Lifestyle Model was developed based on daily living activities. A training booklet was created based on 11 daily living activities (providing and maintaining a safe environment, communication, breathing, nutrition, etc.). To increase the effectiveness of the training, a booklet based on this model will be prepared and used as a guide in the training program. | Other | Experimental: Intervention Group: Urinary catheter care training |
Primary outcome
CAUTI Prevention Attitude
Time frame: Time Frame: "Baseline (discharge planning day)" Time Frame: "Day of catheter removal (within 3-7 days after discharge)
The scale developed by Koçyiğit Kavak et al. (2024) is a 31-item instrument designed to assess patients' attitudes towards preventing catheter-associated urinary tract infections. The Turkish validity and reliability study of the scale was conducted by Koçyiğit Kavak et al. in 2024. The Cronbach's alpha coefficient of the scale was reported as 0.882. The scale consists of 31 items in a five-point Likert type format, with response options ranging from "Never = 1," "Rarely = 2," "Sometimes = 3," "Often = 4," to "Always = 5." The minimum possible score is 31, and the maximum score is 155. Higher scores indicate more positive patient attitudes towards preventing catheter-associated urinary tract infections.
Anxiety
Time frame: Time Frame: "Baseline (discharge planning day)" Time Frame: "Day of catheter removal (within 3-7 days after discharge)
To determine individuals' anxiety levels, the State-Trait Anxiety Inventory (STAI) will be used. The scale consists of a total of 40 items and is a four-point Likert-type instrument composed of two subscales: the State Anxiety Inventory (first 20 items) and the Trait Anxiety Inventory (last 20 items). The State Anxiety subscale measures how an individual feels at a particular time and under specific conditions, whereas the Trait Anxiety subscale assesses how an individual generally feels regardless of the situation and conditions. A score between 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 26698670Safdar N, Codispoti N, Purvis S, Knobloch MJ. Patient perspectives on indwelling urinary catheter use in the hospital. Am J Infect Control. 2016 Mar 1;44(3):e23-4. doi: 10.1016/j.ajic.2015.10.011. Epub 2015 Dec 14.
- Background: PubMed 24592522Inman DM, Jacobson TM, Maxson PM, Wang H, Lohse CM. Effects of urinary catheter education for patients undergoing prostatectomy. Urol Nurs. 2013 Nov-Dec;33(6):289-98.
- Background: PubMed 39341718Drake MJ, Clavica F, Murphy C, Fader MJ. Innovating Indwelling Catheter Design to Counteract Urinary Tract Infection. Eur Urol Focus. 2024 Sep;10(5):713-719. doi: 10.1016/j.euf.2024.09.015. Epub 2024 Sep 28.
- Background: PubMed 19631064Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.
- Background: PubMed 30680418Laan BJ, Nieuwkerk PT, Geerlings SE. Patients knowledge and experience with urinary and peripheral intravenous catheters. World J Urol. 2020 Jan;38(1):57-62. doi: 10.1007/s00345-018-02623-4. Epub 2019 Jan 24.
- Background: PubMed 37058702Garcia DM, Makic MBF, Casey K. Rounding and Quick Access Education to Reduce Catheter-Associated Urinary Tract Infections. Clin Nurse Spec. 2023 May-Jun 01;37(3):117-123. doi: 10.1097/NUR.0000000000000741.
- Background: PubMed 28464815Parker V, Giles M, Graham L, Suthers B, Watts W, O'Brien T, Searles A. Avoiding inappropriate urinary catheter use and catheter-associated urinary tract infection (CAUTI): a pre-post control intervention study. BMC Health Serv Res. 2017 May 2;17(1):314. doi: 10.1186/s12913-017-2268-2.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is conducted as part of a master thesis, and the collected data will be used only for the purposes of the study and related publications
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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.
Aylin ÖZAKGÜL contact
Aylin ÖZAKGÜL study director
Istanbul University - Cerrahpasa
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 on Urinary Catheter Care in people with Catheter Associated Urinary Tract Infection and Indwelling Urinary Catheter, run by Istanbul University - Cerrahpasa 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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra ATA (+905398417871, kubraata@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAUTI Prevention Attitude (time frame: Time Frame: "Baseline (discharge planning day)" Time Frame: "Day of catheter removal (within 3-7 days after discharge)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07172750, which also lists 7 linked publications.
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 15 Sep 2025.