NCT06179238

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

November 19, 2023

Last Update Submit

December 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Study Arms (2)

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.

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.

Other: without patient education

Interventions

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.

Patient with urinary catheter receiving patient education

without patient education

Patient with urinary catheter without patient education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the study
  • Urinary catheterization
  • Being conscious
  • To be able to do self-care

You may not qualify if:

  • Not volunteering to participate in the study
  • Lack of awareness
  • Inability to take care of themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu Training and Research Hospital

Kastamonu, 37000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Disease

Interventions

Educational StatusPatient Education as Topic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 19, 2023

First Posted

December 21, 2023

Study Start

July 30, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations