NCT06829927

Brief 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 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).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 17, 2025

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

July 19, 2024

Last Update Submit

February 11, 2025

Conditions

Keywords

urinary cathethercomfortself-efficiaty

Outcome Measures

Primary Outcomes (1)

  • 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.

    after catheterization ( First 1 hour)

Secondary Outcomes (2)

  • Second Follow-up (Urinary Catheter Self-Efficacy Scale and Comfort Scale)

    6 hours

  • Third Follow-up(Urinary Catheter Self-Efficacy Scale and Comfort Scale)

    24 Hours

Study Arms (2)

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.

Behavioral: e-book

Interventions

e-bookBEHAVIORAL

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.

intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who incompletely completed the data collection tool
  • Patients with hearing, vision and comprehension problems,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat/Merkez, Tokat Province, 6050, Turkey (Türkiye)

RECRUITING

Study Officials

  • Hülya Koçyiğit KAVAK

    Cumhuriyet University

    STUDY CHAIR
  • Şerife Karagözoğlu, Prof. Dr.

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şeyda KAZANÇ, Asst. Prof.

CONTACT

Hülya Koçyiğit KAVAK, Asst. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind method will be used in the study. Participants will not know which group they are assigned to and statistics will be performed by an independent person to minimize the risk of bias
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Öğr. Gör. Dr.

Study Record Dates

First Submitted

July 19, 2024

First Posted

February 17, 2025

Study Start

September 15, 2024

Primary Completion

October 15, 2025

Study Completion

December 30, 2025

Last Updated

February 17, 2025

Record last verified: 2024-09

Locations