Mothers of Children With ColostomyNCT07662707
Effectiveness of a Digital Educational Booklet on Mothers' Colostomy Care Knowledge and Practices
A study testing digital education and simulation-supported training intervention in people with Mothers of Children With Colostomy and A Multi-component Educational Program, run by King Saud Bin Abdulaziz University for Health Sciences at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mothers of Children With Colostomy, A Multi-component Educational Program, Digital Booklet
- What is being tested?
- digital education and simulation-supported training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A mother and a child with colostomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Mothers of Children With Colostomy, A Multi-component Educational Program, Digital Booklet, WhatsApp, Voice-over Explanations, Animated Videos
- Being tested
- digital education and simulation-supported training intervention
- Keywords
- children with colostomy, a multi-component educational program, digital booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital education and simulation-supported training interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: digital education and simulation-supported training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start15 Nov 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mothers of Children With ColostomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud Bin Abdulaziz University for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amel Abouelfettoh, King Saud Bin Abdulaziz University for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662707
- Sponsor's protocol ID
- ERCNMA 1000/5/11/181/25
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Need
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Care for Little Lives: Effectiveness of a Digital Educational Booklet on Mothers' Colostomy Care Knowledge and Practices-
- ClinicalTrials.gov ID
- NCT07662707
- Acronym / sponsor ID
- ERCNMA 1000/5/11/181/25
- Conditions
- Mothers of Children With Colostomy, A Multi-component Educational Program, Digital Booklet, WhatsApp, Voice-over Explanations, Animated Videos
- Keywords
- children with colostomy, a multi-component educational program, digital booklet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Saud Bin Abdulaziz University for Health SciencesUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 23 Jun 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: digital education and simulation-supported training interventionThe 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A mother and a child with colostomy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| digital education and simulation-supported training interventionMothers 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. | Other | intervention group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. No Need
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 digital education and simulation-supported training intervention in people with Mothers of Children With Colostomy and A Multi-component Educational Program, run by King Saud Bin Abdulaziz University for Health Sciences 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and practice scores related to colostomy care (time frame: 12 weeks follow up). The study lists 2 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 23 Jun 2026.