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临床试验/NCT07450742
NCT07450742尚未招募不适用

The Effect of Health Education Supported by Digital Storytelling on Maternal Knowledge and Attitudes Towards Newborn Screening

Kirsehir Ahi Evran Universitesi0 个研究点目标入组 128 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
128
主要终点
Maternal Knowledge and Attitude Scale Towards Newborn Screening

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: HEALTH EDUCATION SUPPORTED BY DIGITAL STORYTELLING (Behavioral)

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.

结局指标

主要结局

Maternal Knowledge and Attitude Scale Towards Newborn Screening

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gizem Deniz Büyüksoy

Assoc. Prof.

Kirsehir Ahi Evran Universitesi

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