NCT07662707

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

children with colostomya multi-component educational programdigital booklet

Outcome Measures

Primary Outcomes (2)

  • knowledge and practice scores related to colostomy care

    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

    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

Study Arms (1)

intervention group

EXPERIMENTAL

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

Interventions

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.

intervention group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA mother who are providing care for a child with colostomy
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A mother and a child with colostomy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Univerity

Cairo, 12613, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profewssor

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

November 15, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

No Need

Locations