Urostomy Patients0841NCT07370324
Stoma Educational Program on Self-Care Practices
A study testing education in people with Urostomy Patients and Self-Care Practices, run by Mansoura University at 1 site in Egypt.
Trial summary
provide a stoma educational program and evaluate the self-care practices and life satisfaction of urostomy patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Urostomy Patients, Self-Care Practices
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2025to Mar 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- can communicate verbally
- accepted to engage in the study
Who cannot join
- psychiatric patients
- patient with chronic diseases that interfere with their self-care activities as
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Knowledge to Confidence: The Effect of a Stoma Educational Program on Self-Care Practices and Life Satisfaction of Urostomy Patients
provide a stoma educational program and evaluate the self-care practices and life satisfaction of urostomy patients.
Read the detailed description
The data will be collected from urostomy patients and their medical records to establish a baseline for their knowledge and educational needs. The researcher will provide an illustrated colored instructional booklet. designed educational intervention will be implemented on urostomy patients in multiple sessions
- Conditions
- Urostomy Patients, Self-Care Practices
- Being tested
- education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
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 | Role | What they receive |
|---|---|---|
| control | No intervention | routine hospital care |
| study group | Experimental | receive educational intervention Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Evaluation of patient self- efficacy immediately post- operative and 3 months later
Secondary outcomes (1)
quality-of-life mean score
The urinary diversion quality of life questionnaire designed to assess quality of life for urinary diversion patients. It consists of questions that explored general condition and physical condition, reconstruction-related symptoms, psychological status, sexual life, social status, and satisfaction with the treatment. Patients' responses were categorized as follows: 1- not at all, 2- a little, 3- much, 4- very much.
Measured: Assess patients' quality of life 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start10 Dec 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urostomy PatientsStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abubakr Mohamed Salama, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370324
- Sponsor's protocol ID
- Stoma Educational Program
- Acronym
- 0841
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Knowledge to Confidence: The Effect of a Stoma Educational Program on Self-Care Practices and Life Satisfaction of Urostomy Patients
- ClinicalTrials.gov ID
- NCT07370324
- Acronym / sponsor ID
- 0841 / Stoma Educational Program
- Conditions
- Urostomy Patients, Self-Care Practices
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Jan 2026 (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.
provide a stoma educational program and evaluate the self-care practices and life satisfaction of urostomy patients.
Detailed description
The data will be collected from urostomy patients and their medical records to establish a baseline for their knowledge and educational needs. The researcher will provide an illustrated colored instructional booklet. designed educational intervention will be implemented on urostomy patients in multiple sessions
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –routine hospital care |
| study group | Experimental | Other: educationreceive educational intervention |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- can communicate verbally
- accepted to engage in the study
Key exclusion criteria (2 listed)
- psychiatric patients
- patient with chronic diseases that interfere with their self-care activities as
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 |
|---|---|---|
| educationEducational 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. | Other | study group |
Primary outcome
knowledge mean score
Time frame: Evaluation of patients' knowledge immediately post and 3 months later
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.
Self-care mean score
Time frame: Evaluation of patients' knowledge immediately and 3 months later
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.
Self-efficacy mean score
Time frame: Evaluation of patient self- efficacy immediately post- operative and 3 months later
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.
1 secondary outcome
quality-of-life mean score
Time frame: Assess patients' quality of life 3 months later
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 29 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Urostomy Patients and Self-Care Practices, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge mean score (time frame: Evaluation of patients' knowledge immediately post and 3 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.