Cairo Univerity
Cairo, 12613, Egypt
Completed
NCT Number: NCT07662707
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.
Completed
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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A mother and a child with colostomy
Exclusion criteria
- None
Treatment and study plan
digital education and simulation-supported training intervention
OtherMothers 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.
Primary outcomes
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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
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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.
Sponsors and collaborators
Lead sponsor
King Saud Bin Abdulaziz University for Health Sciences
Other
Registry information
Official study title
Smart Care for Little Lives: Effectiveness of a Digital Educational Booklet on Mothers' Colostomy Care Knowledge and Practices-
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 23, 2026
- Registry last updated
- Jun 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.