- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168344
The Effect of Web-based Training Given to Mothers of Babies With Congenital Heart Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Eskişehir, Turkey
- Eskişehir Osmangazi University Health Practice and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
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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
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|
No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Interview Form
Time Frame: In the first stage of the research; Qualitative data were collected: once
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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.
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In the first stage of the research; Qualitative data were collected: once
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent-Baby Identification Information Form
Time Frame: Form was administered to mothers in both groups before the study: once.
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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.
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Form was administered to mothers in both groups before the study: once.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Scale Short Form (SF-36)
Time Frame: SF-36 was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)
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SF-36 is a 36-question measurement tool that examines eight dimensions of health-related quality of life.
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SF-36 was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)
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Generalized Perceived Self-Efficacy Scale (GASS)
Time Frame: GASS was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)
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GASS is a 10-item scale that measures the self-efficacy level of mothers
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GASS was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Berna EREN FİDANCI, Assoc. Prof., University of Saglik Bilimleri
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHF_NU1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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