NCT06168344

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

November 2, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

Congenital Heart DiseaseWeb-Based EducationMothersInfantsCarePediatric Nursing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Parent-Baby Identification Information Form

    Form was administered to mothers in both groups before the study: once.

Other Outcomes (2)

  • Quality of Life Scale Short Form (SF-36)

    SF-36 was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)

  • Generalized Perceived Self-Efficacy Scale (GASS)

    GASS was applied to mothers in the intervention and control groups: pretest-posttest, twice (15 minutes)

Study Arms (2)

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.

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.

Interventions

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

Intervention Group

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University Health Practice and Research Hospital

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Berna EREN FİDANCI, Assoc. Prof.

    University of Saglik Bilimleri

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 2, 2023

First Posted

December 13, 2023

Study Start

February 1, 2022

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Locations