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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06168344
Other study ID # GHF_NU1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date August 15, 2023

Study information

Verified date December 2023
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 12 Months
Eligibility 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 Design


Intervention

Other:
Web-Based Education Program
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

Locations

Country Name City State
Turkey Eskisehir Osmangazi University Health Practice and Research Hospital Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life Scale Short Form (SF-36) SF-36 is a 36-question measurement tool that examines eight dimensions of health-related quality of life. SF-36 was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)
Other Generalized Perceived Self-Efficacy Scale (GASS) GASS is a 10-item scale that measures the self-efficacy level of mothers GASS was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)
Primary 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. In the first stage of the research; Qualitative data were collected: once
Secondary 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. Form was administered to mothers in both groups before the study: once.
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