- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370324
Stoma Educational Program on Self-Care Practices (0841)
From Knowledge to Confidence: The Effect of a Stoma Educational Program on Self-Care Practices and Life Satisfaction of Urostomy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt, 35516
- Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- can communicate verbally
- accepted to engage in the study
Exclusion Criteria:
- psychiatric patients
- patient with chronic diseases that interfere with their self-care activities as
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
routine hospital care
|
|
|
Experimental: study group
receive educational intervention
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Evaluation of patients' knowledge immediately post and 3 months later
|
|
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.
|
Evaluation of patients' knowledge immediately and 3 months later
|
|
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.
|
Evaluation of patient self- efficacy immediately post- operative and 3 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality-of-life mean score
Time Frame: Assess patients' quality of life 3 months later
|
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.
|
Assess patients' quality of life 3 months later
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stoma Educational Program
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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