MothersNCT06168344
The Effect of Web-based Training Given to Mothers of Babies With Congenital Heart Disease
A study testing Web-Based Education Program in people with Mothers and Quality of Life, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Mothers, Quality of Life, Self Efficacy
- What is being tested?
- Web-Based Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 15 Aug 2023
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For mothers;
- Having a baby with congenital heart disease
- Being over 18 years of age
- Being literate
- Being able to speak and understand Turkish
- There is no health problem that may prevent participation in training.
Show all 13Show fewer
- Being able to use a computer/mobile phone
- Being able to use and have internet access
- Volunteering to participate in research
- For babies;
- Those born at or after the 37th week of gestation and those with congenital heart disease, aged 0-12 months
- Has not had heart surgery
- Babies who do not have any other chronic diseases
Who cannot join
- Filling out forms incompletely
- Being a foreign national
- Having vision or hearing problems
- To give up participating in the research
- Mothers and babies who have physical/mental problems that may affect the research results during the study period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Health Practice and Research Hospital
Eskişehir
About this study
Official title: The Effect of Web-Based Education Given to Mothers of Infants With Congenital Heart Disease on Quality of Life and Self Efficacy
This study was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels. The study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type.
The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital.
Read the detailed description
Materials and Methods: study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type. The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital. "Qualitative interview form, Parent-infant Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale" were used. The research process had two stages; in the first stage, qualitative data was collected and after qualitative interviews with mothers, the content of the web-based training was created in line with the needs of the mothers. In the second stage, quantitative data were collected, and a web-based training program was applied to the intervention group and an outpatient clinic routine to the control group.
- Conditions
- Mothers, Quality of Life, Self Efficacy, Training
- Being tested
- Web-Based Education Program
- Keywords
- Congenital Heart Disease, Web-Based Education, Mothers, Infants, Care, Pediatric Nursing
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Education ProgramOther
This study was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Mothers were assigned to groups by simple randomization method. The website was designed, mothers were given their usernames and passwords and their memberships were created. Pretests (Parent-Baby Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were administered via the website. Mothers completed the modules in the web-based training program within four weeks. Four weeks later, posttests (Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were administered via the website. Receives: Other: Web-Based Education Program |
| Control Group | No intervention | Mothers' usernames and passwords were created and website memberships were made. Pretests (Parent-Baby Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were applied. Website use by mothers in the control group was restricted and access to web-based educational content was closed to all mothers in this group. The mothers in the control group were applied the hospital outpatient clinic routine without any intervention. Four weeks later, posttests (Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were administered via the website. Pre-test and post-tests of mothers in the control group were collected via the website. After the research data was collected, a web-based training program was opened to the mothers in the control group and they were allowed to benefit from the training content. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview Form
In the first stage of the research; Qualitative data were collected. Qualitative interviews were conducted with mothers (n=11). Seven open-ended questions were asked. Categories and themes were arranged according to the content analysis created from the data. The content of the Web-based training program was created in line with the needs and requirements of mothers according to categories and themes.
Measured: In the first stage of the research; Qualitative data were collected: once
Secondary outcomes (1)
Parent-Baby Identification Information Form
The form consists of a total of 23 questions and two sections. The first part consists of 14 questions to evaluate the socio-demographic characteristics of parents. Second part consists of nine questions to evaluate the demographic characteristics of babies.
Measured: Form was administered to mothers in both groups before the study: once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Feb 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Eren Fidancı, Saglik Bilimleri Universitesi
- Investigators
- Berna EREN FİDANCI, Assoc. Prof., Study director, University of Saglik Bilimleri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168344
- Sponsor's protocol ID
- GHF_NU1
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Education Given to Mothers of Infants With Congenital Heart Disease on Quality of Life and Self Efficacy
- ClinicalTrials.gov ID
- NCT06168344
- Acronym / sponsor ID
- GHF_NU1
- Conditions
- Mothers, Quality of Life, Self Efficacy, Training
- Keywords
- Congenital Heart Disease, Web-Based Education, Mothers, Infants, Care, Pediatric Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 13 Dec 2023 (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 was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels. The study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type.
The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital.
Detailed description
Materials and Methods: study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type. The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital. "Qualitative interview form, Parent-infant Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale" were used. The research process had two stages; in the first stage, qualitative data was collected and after qualitative interviews with mothers, the content of the web-based training was created in line with the needs of the mothers. In the second stage, quantitative data were collected, and a web-based training program was applied to the intervention group and an outpatient clinic routine to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Web-Based Education ProgramMothers were assigned to groups by simple randomization method. The website was designed, mothers were given their usernames and passwords and their memberships were created. Pretests (Parent-Baby Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were administered via the website. Mothers completed the modules in the web-based training program within four weeks. Four weeks later, posttests (Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were administered via the website. |
| Control Group | No intervention | –Mothers' usernames and passwords were created and website memberships were made. Pretests (Parent-Baby Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were applied. Website use by mothers in the control group was restricted and access to web-based educational content was closed to all mothers in this group. The mothers in the control group were applied the hospital outpatient clinic routine without any intervention. Four weeks later, posttests (Quality of Life Scale and Generalized Perceived Self-Efficacy Scale) were administered via the website. Pre-test and post-tests of mothers in the control group were collected via the website. After the research data was collected, a web-based training program was opened to the mothers in the control group and they were allowed to benefit from the training content. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- For mothers;
- Having a baby with congenital heart disease
- Being over 18 years of age
- Being literate
- Being able to speak and understand Turkish
Key exclusion criteria (5 listed)
- Filling out forms incompletely
- Being a foreign national
- Having vision or hearing problems
- To give up participating in the research
- Mothers and babies who have physical/mental problems that may affect the research results during the study period.
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 |
|---|---|---|
| Web-Based Education ProgramThis study was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels | Other | Intervention Group |
Primary outcome
Qualitative Interview Form
Time frame: In the first stage of the research; Qualitative data were collected: once
In the first stage of the research; Qualitative data were collected. Qualitative interviews were conducted with mothers (n=11). Seven open-ended questions were asked. Categories and themes were arranged according to the content analysis created from the data. The content of the Web-based training program was created in line with the needs and requirements of mothers according to categories and themes.
1 secondary outcome
Parent-Baby Identification Information Form
Time frame: Form was administered to mothers in both groups before the study: once.
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 13 Dec 2023.
- Individual participant dataSharing planned: Yes
Related trials for Mothers
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
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.
Berna EREN FİDANCI, Assoc. Prof. study director
University of Saglik Bilimleri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Education Program in people with Mothers and Quality of Life, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 13 inclusion and 5 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 13 Dec 2023. 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 Turkey (Türkiye). 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?
Qualitative Interview Form (time frame: In the first stage of the research; Qualitative data were collected: once). 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 13 Dec 2023.