The Effect of the Use of Mobile App

Amasya University

Status: Completed

Conditions: Sudden Infant Death Syndrome

Treatments: Other: Standard Care; Behavioral: Education and Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT07032402

04012024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental: Group I

Experimental group

Description:

Behavioral and Counseling

Treatment:

Behavioral: Education and Counseling

Control: Group II

Other group

Description:

Standard Care

Treatment:

Other: Standard Care