- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450742
Digital Storytelling and Mother's Knowledge and Attitudes Towards Newborn Screning
The Effect of Health Education Supported by Digital Storytelling on Maternal Knowledge and Attitudes Towards Newborn Screening
The aim of this study is to examine the effect of health education supported by digital storytelling on mothers' knowledge and attitudes towards newborn screening. It is a single-blind, controlled-group, randomized controlled experimental study. The hypotheses of the study are:
H0: Health education supported by digital storytelling has no effect on mothers' knowledge and attitudes towards newborn screening.
H1: Health education supported by digital storytelling has an effect on mothers' knowledge and attitudes towards newborn screening. Participants will:
- Be 28-32 weeks pregnant
- Be able to speak and understand Turkish
- Use a smartphone with internet access
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will first obtain a list of pregnant women registered with each family physician at the family health centers in city center. This list will include the pregnant women's names, surnames, ages, and contact information. The pregnant women forming the research group will be contacted using the phone numbers obtained from the family health centers. After explaining the subject and importance of the study, they will be asked if they are willing to participate. The list forming the research group will be updated to include only those who volunteer for the study. Then, as a pre-test, an introductory information form and the Maternal Knowledge and Attitudes Towards Newborn Screening Scale will be administered to the individuals in the research group. After the pre-test is completed, the pregnant women in the research group will be assigned to experimental and control groups using stratified randomization according to their age. For this purpose, the pregnant women will be divided into two strata: those aged 18-35 and those over 35. After stratification, four blocks of eight people each were created, forming two separate groups, using the website randomizer.org.
Blinding In the study, the randomization process will be performed by someone other than a member of the research team, ensuring blinding. The experimental and control groups will be coded as A and B, ensuring statistical blinding as the statistician analyzing the data will not know whether the pregnant women are in the experimental or control group. Furthermore, participants will not be informed whether they are in the experimental or control group, ensuring participant blinding. Since the intervention will be performed by the researcher, researcher blinding was not possible. Thus, assignment bias, statistical bias, and reporting bias were prevented.
Outcomes Measures The outcome criterion in the study is the level of knowledge and attitude towards newborn screening. The measurement tool aimed at measuring this criterion is the Maternal Knowledge and Attitude Scale Towards Newborn Screening. The pre-test will be administered through self-report at the family health centers where the interviews with pregnant women are conducted, and the post-test will be administered through face-to-face interviews after the completion of a four-week health education program supported by digital storytelling. Intervention to be Applied to the Control Group: Two interviews will be conducted with the pregnant women in the control group at family health centers, four weeks apart. The pre-test will be administered in the first interview, and the post-test in the last interview. Telephone calls will be made to participants between the first and last weeks for reminder purposes.
Data Analysis The findings of the study will be analyzed in a computer environment. Intention to Treat (ITT) analysis will be performed to complete the missing data in the final test. Paired-sample t-test and independent samples t-test will be used for continuous data showing normal distribution. McNemar test for two dependent groups and chi-square test for two independent groups will be applied to categorical variables.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 28-32 weeks pregnant
- Being able to speak and understand Turkish
- Using a smartphone with internet access
Exclusion Criteria:
- Not having previously given birth to a live child/Being a first-time mother
- Having a diagnosed or suspected congenital disease in the baby
- The pregnant woman having a vision or hearing problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in this arm will receive the structured health education supported by digital storytelling program consisting of 4 sessions delivered over 4 weeks.
The program includes health education, face-to-face interview and digital storytelling related to newborn screening.
Sessions will be conducted by trained personnel according to a standardized protocol.
|
The health education program, supported by digital storytelling, to be applied to the experimental group is a four-week program.
Sessions will be held face-to-face at family health centers one week apart.
Telephone calls will be made during the first week to remind participants or inform them about their appointments.
Four stories were created for the digital storytelling-supported health education program for the experimental group, using the website www.storyjumper.com.
The first story covers the purpose and scope of newborn screenings, the second the testing process and possible outcomes, the third the definition of diseases and treatment options, and the fourth the parents' right to information and responsibility to participate in screenings.
|
|
No Intervention: Control Group
Participants in this arm will not receive the intervention program.
They will continue with usual activities and/or standard care during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Knowledge and Attitude Scale Towards Newborn Screening
Time Frame: Four weeks
|
The outcome criterion in this study is the level of knowledge and attitudes towards newborn screening.
The measurement tool aimed at measuring this criterion is the Maternal Knowledge and Attitude Scale Towards Newborn Screening.
The pre-test will be administered through self-report at family health centers where interviews are conducted with pregnant women, and the post-test will be administered through face-to-face interviews after the completion of a four-week health education program supported by digital storytelling.
|
Four weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 2025-18/240
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.
Clinical Trials on Digital Storytelling
-
Kirsehir Ahi Evran UniversitesiActive, not recruitingHealth Promotion | Older Adults (65 Years and Older) | Digital StorytellingTurkey (Türkiye)
-
Gazi UniversityCompletedNursing Students | Role Playing | Ethical Sensitivities | Analyses, Ethical | Digital Storytelling | Ethics Education | Ethical BehaviorTurkey
-
Harran UniversityNot yet recruitingDigital Addiction | Digital Literacy | Social Comparison
-
Giresun UniversityRecruitingDigital Literacy | Digital Privacy | Online Privacy AwarenessTurkey (Türkiye)
-
Jessa HospitalNot yet recruiting
-
Jessa HospitalRecruitingDigital HealthBelgium
-
Jessa HospitalNot yet recruiting
-
University of California, San FranciscoCompleted
-
Singapore Management UniversityNot yet recruitingDigital Mindfulness Intervention
Clinical Trials on HEALTH EDUCATION SUPPORTED BY DIGITAL STORYTELLING
-
Saglik Bilimleri UniversitesiCompletedDiabetes | Educational ProblemsTurkey
-
Gazi UniversityGazi UniversityActive, not recruitingLevel of Digital Game Addiction | Level of CyberbullyingTurkey
-
Stanford UniversityHealthPals, IncCompletedCoronary Artery Disease | Hypertension | Diabetes | Insulin Resistance | Dyslipidemias | PreDiabetes | Prehypertension | Cardiovascular Risk FactorUnited States
-
Baskent UniversityRecruiting
-
Monash UniversityCaring Pharmacy; Bionime CorporationCompleted
-
T.C. ORDU ÜNİVERSİTESİNot yet recruitingHealth Education | Cervical Cancers | Peer Support
-
Michigan State UniversityRecruiting
-
Abant Izzet Baysal UniversityNot yet recruitingEducation | Nurse's Role | Mental Health LiteracyTurkey
-
Arizona State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHealth Knowledge, Attitudes, Practice | COVID-19 Pandemic | Vaccine-Preventable Diseases | Health-Related Behavior | NarrationUnited States
-
German Diabetes CenterCompletedType 2 Diabetes | Fatty Liver, NonalcoholicGermany