NCT07172750

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

August 28, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

Catheter associated urinary tract infectionAnxietyself-careUrologic Surgerypatient education

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Time Frame: "Baseline (discharge planning day)" Time Frame: "Day of catheter removal (within 3-7 days after discharge)

Study Arms (2)

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).

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.

Interventions

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.

Experimental: Intervention Group: Urinary catheter care training

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpasa

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 26698670BACKGROUND
  • Inman 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.

    PMID: 24592522BACKGROUND
  • Drake 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.

    PMID: 39341718BACKGROUND
  • Ryan 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.

    PMID: 19631064BACKGROUND
  • Laan 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.

    PMID: 30680418BACKGROUND
  • Garcia 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.

    PMID: 37058702BACKGROUND
  • Parker 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.

    PMID: 28464815BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Aylin ÖZAKGÜL

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc canditate of nursing

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 15, 2025

Study Start

September 15, 2025

Primary Completion

February 28, 2026

Study Completion

April 30, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

Locations