NCT07450742

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress58%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 24, 2026

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal Knowledge and Attitude Scale Towards Newborn Screening

    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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: HEALTH EDUCATION SUPPORTED BY DIGITAL STORYTELLING

Control Group

NO INTERVENTION

Participants in this arm will not receive the intervention program. They will continue with usual activities and/or standard care during the study period.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 28-32 weeks pregnant
  • Being able to speak and understand Turkish
  • Using a smartphone with internet access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03