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临床试验/NCT07032402
NCT07032402已完成不适用

The Effect of the Use of ABÖS-M App Developed for Mothers With Newborn Babies on Knowledge, Skills and Self-Efficacy Levels: Randomized Controlled Study

Amasya University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Knowledge

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Knowledge

时间窗: at the end of the invervention program (4 weeks after from baseline)

The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.

Care Skills

时间窗: at the end of the invervention program (4 weeks after from baseline)

The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.

Self-Efficacy

时间窗: at the end of the invervention program (4 weeks after from baseline)

The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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