The Effect of the Use of Mobile App

NCT ID: NCT07032402

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-25

Brief Summary

This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death Syndrome (SIDS).

Detailed Description

Informing and raising parental awareness on Sudden Infant Death Syndrome (SIDS) and safe sleeping practices is crucial for promoting public health. This study aims to inform mothers about the risk factors involved in SIDS and encourage them to maintain a safe sleeping environment to safeguard their babies. As part of this study, the investigators intend to create a personalised, gamified mobile application training programme for mothers called the ABÖS-M App. Our main objective is to analyse the impact of ABÖS-M App on the knowledge, skills, and self-efficacy levels of mothers. To date, the investigators have not found any randomised controlled studies in Turkey that aim to prevent SIDS. Our study was designed as a single-centre, follow-up, single-blind, randomised controlled trial. The study was designed to include 25 mothers each in the intervention and control groups. The data was collected through a set of forms including the Information Form for Infants and Parents, the Sudden Infant Death Syndrome Knowledge Level Self-Assessment Form, the Sudden Infant Death Syndrome Care Skills Form, and the General Self-Efficacy Scale. Data analysis will be conducted using the Statistical Package for Social Science (SPSS v.23) software licensed by Akdeniz University. Repeated measures will be employed in the investigation to compare the measurements and scores between the intervention and control groups. Spearman correlation analysis will be utilised to evaluate the degree of relationship between the measurements. A significance level of p<0.05 will be considered. Additionally, the effect size of the study will be computed. Consequently, it is anticipated that the ABÖS-M App will enhance the knowledge, skills and self-efficacy levels of the mothers by the end of this project.

Conditions

Sudden Infant Death Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental: Group I

Behavioral and Counseling

Group Type: EXPERIMENTAL

Education and Counseling

Intervention Type: BEHAVIORAL

Mothers who consent will have the ABÖS-M App installed on their smartphones and will create a personal login. Researchers will provide brief training on how to use the app. The intervention consists of four educational modules designed with individualized and gamified content. Mothers are expected to complete all modules within two weeks. The app monitors their progress and provides automated feedback based on their performance, encouraging mothers to review topics if needed. Weekly WhatsApp reminders will be sent to promote app engagement, and researchers will track login frequency and usage time. Mothers who fail to complete the modules within the specified timeframe will be excluded from the study. Participants will also be asked to fill out a daily care diary throughout the intervention period.

Control: Group II

Standard Care

Group Type: OTHER

Standard Care

Intervention Type: OTHER

After obtaining written and verbal consent, the ABÖS-M App will be installed on their smartphones, and researchers will provide face-to-face instructions on its basic use. Mothers in the control group will receive routine newborn care education provided by clinical nurses, which includes non-standardized safe sleep information typically given before hospital discharge. No structured or individualized training will be provided by the researchers during the study period. For one month, control group participants will have limited access to certain app features, including the "About Us" section, care diary, and assessment tools. Mothers will be asked to complete the care diary daily, and researchers will send regular reminders.

Interventions

Education and Counseling

Mothers who consent will have the ABÖS-M App installed on their smartphones and will create a personal login. Researchers will provide brief training on how to use the app. The intervention consists of four educational modules designed with individualized and gamified content. Mothers are expected to complete all modules within two weeks. The app monitors their progress and provides automated feedback based on their performance, encouraging mothers to review topics if needed. Weekly WhatsApp reminders will be sent to promote app engagement, and researchers will track login frequency and usage time. Mothers who fail to complete the modules within the specified timeframe will be excluded from the study. Participants will also be asked to fill out a daily care diary throughout the intervention period.

Intervention Type: BEHAVIORAL

Standard Care

After obtaining written and verbal consent, the ABÖS-M App will be installed on their smartphones, and researchers will provide face-to-face instructions on its basic use. Mothers in the control group will receive routine newborn care education provided by clinical nurses, which includes non-standardized safe sleep information typically given before hospital discharge. No structured or individualized training will be provided by the researchers during the study period. For one month, control group participants will have limited access to certain app features, including the "About Us" section, care diary, and assessment tools. Mothers will be asked to complete the care diary daily, and researchers will send regular reminders.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Mothers with a healthy newborn baby,
• Mothers who have not experienced any previous child loss,
• Mothers with at least a primary school education,
• Mothers who own a smartphone with mobile internet access,
• Mothers who speak Turkish, are able to understand written and spoken information, follow instructions, and have no communication barriers,
• Mothers who voluntarily agree to participate in the study.

Exclusion Criteria

• Mothers with postpartum depression,
• Mothers who do not complete the educational program within 15 days,
• Mothers who request withdrawal from the study at any stage.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Health Institutes of Turkey

OTHER_GOV

Sponsor Role: collaborator

Amasya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

04012024

Identifier Type: -

Identifier Source: org_study_id