NCT07370324

Brief Summary

provide a stoma educational program and evaluate the self-care practices and life satisfaction of urostomy patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

December 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 18, 2026

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • knowledge mean score

    measured by a questionnaire designed in the form of multiple-choice questions. Each answer receives one degree, with the exception of unknown and missed answers, which receive zero points. The scores obtained for each question were summed up to get the total score for the patients' knowledge.

    Evaluation of patients' knowledge immediately post and 3 months later

  • Self-care mean score

    Standardized, numerical, validated, and evidence-based measures are used to assess the stoma self-care abilities of patients undergoing UD. It comprises seven skills required to change a urostomy pouch system. Each ability was graded on a four-point scale, with values ranging from 0 to 3.

    Evaluation of patients' knowledge immediately and 3 months later

  • Self-efficacy mean score

    It is designed to assess a general sense of perceived self-efficacy, aiming to predict how individuals cope with daily hassles and adapt after experiencing various stressful life events, in addition to the challenges posed by the disease. Patients' responses will be categorized as follows: 1 = not being confident at all, 2 = slightly confident, 3 = fairly confident, 4 = highly confident, and 5 = extremely confident. High scores refer to positive self-efficacy, i.e., the subjective presence of ability. So the total score is 100, whereas less than 50 = low (-ve) self-efficacy and more than 50 = high (+ve) self-efficacy.

    Evaluation of patient self- efficacy immediately post- operative and 3 months later

Secondary Outcomes (1)

  • quality-of-life mean score

    Assess patients' quality of life 3 months later

Study Arms (2)

control

NO INTERVENTION

routine hospital care

study group

EXPERIMENTAL

receive educational intervention

Other: education

Interventions

Educational intervention will be implemented to urostomy patients in multiple sessions, which will be divided into theoretical and practical sessions as following: Theoretical session: This part will include knowledge about anatomy and physiology of urinary system, pre and post operative care, complication and life style modifications…etc. Practical session: This session will cover care of urostomy including pouch system, changing of pouch, empty of pouch, self- catheterization and irrigation of urostomy.

study group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • can communicate verbally
  • accepted to engage in the study

You may not qualify if:

  • psychiatric patients
  • patient with chronic diseases that interfere with their self-care activities as

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist prof

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 27, 2026

Study Start

December 10, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations