Effectiveness of a Digital Educational Booklet on Mothers' Colostomy Care Knowledge and Practices

June 17, 2026 updated by: Amel Abouelfettoh, King Saud Bin Abdulaziz University for Health Sciences

Smart Care for Little Lives: Effectiveness of a Digital Educational Booklet on Mothers' Colostomy Care Knowledge and Practices-

This study aimed to evaluate the effectiveness of a digital education and simulation-supported training intervention on mothers' knowledge and practices regarding colostomy care for their children. A randomized controlled trial was conducted among 120 mothers of children with colostomy recruited from the pediatric general surgical unit and outpatient clinic at Monufia University. Participants were randomly assigned to either a study group (n = 60) or a control group (n = 60). The intervention consisted of a multi-component educational program including a digital booklet delivered via WhatsApp, voice-over explanations, animated videos, interactive simulations, researcher demonstration using a simulation model, supervised hands-on practice, daily postoperative supervision, and WhatsApp follow-up support. The control group received routine hospital care. Data were collected using a structured knowledge questionnaire and an observational practice checklist at baseline, immediately post-intervention, before discharge, and at 12-week follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial (RCT) design was adopted in the current study to evaluate the effectiveness of a digital educational booklet on mothers' knowledge and reported practices regarding colostomy care for their children. The RCT design is considered the gold standard for intervention research because it minimizes selection bias and enhances the comparability between study groups through random allocation of participants. In the present study, mothers were randomly assigned to either the intervention group, which received the digital educational booklet in addition to routine hospital care, or the control group, which received routine hospital care only

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Cairo Univerity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A mother and a child with colostomy

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
The intervention consisted of a multi-component educational program including a digital booklet delivered via WhatsApp, voice-over explanations, animated videos, interactive simulations, researcher demonstration using a simulation model, supervised hands-on practice, daily postoperative supervision, and WhatsApp follow-up support
Other: digital education and simulation-supported training intervention
Mothers assigned to the study group received the digital educational booklet during the preoperative phase. The booklet was delivered through WhatsApp using a secure downloadable link. The researchers guided mothers through the educational content, including voice-over explanations, animated videos, illustrated diagrams, and interactive simulation activities. The knowledge component covered essential information related to colostomy care, including the definition and types of colostomy, colostomy bags, nutrition and hydration, normal stoma characteristics, signs of complications, follow-up visits, and indications for seeking medical assistance. Interactive knowledge checks with immediate feedback and motivational reinforcement were integrated throughout the booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge and practice scores related to colostomy care
Time Frame: 12 weeks follow up

Knowledge: A nine items addressing the definition and importance of colostomy, types of colostomies, types of colostomy bags, characteristics of a normal stoma, appropriate clothing, child nutrition, signs of complications, and follow-up visits.

Practice: 11 items assessing mothers' practices related to hand hygiene before and after care, cleaning the stoma and surrounding skin, proper changing and emptying of the colostomy bag, waste disposal, selecting suitable loose-fitting clothing, allowing normal child activities, providing care when a colostomy bag was unavailable, preparing the required supplies before care, ensuring child comfort and safety during procedures, monitoring the stoma and stool characteristics, and recognizing complications requiring medical consultation
12 weeks follow up
knowledge and practice scores related to colostomy care
Time Frame: 12 weeks

for Knowledge: A nine items addressing the definition and importance of colostomy, types of colostomies, types of colostomy bags, characteristics of a normal stoma, appropriate clothing, child nutrition, signs of complications, and follow-up visits.

For Practice: A checklist included 11 items assessing mothers' practices related to hand hygiene before and after care, cleaning the stoma and surrounding skin, proper changing and emptying of the colostomy bag, waste disposal, selecting suitable loose-fitting clothing, allowing normal child activities, providing care when a colostomy bag was unavailable, preparing the required supplies before care, ensuring child comfort and safety during procedures, monitoring the stoma and stool.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud Bin Abdulaziz University for Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERCNMA 1000/5/11/181/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Need

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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