跳至主要内容
临床试验/NCT06030830
NCT06030830招募中不适用

SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study

Bar-Ilan University, Israel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Infant temperament

研究概览

简要总结

In the last decade, infants are born into a social environment in which the smartphone has become an essential part of our lives. Smartphone use draws the mother's attention during mother-infant interactions and thus may affect the infant development as well as maternal self-efficacy. However, the effects of smartphone use reduction among breastfeeding mothers during their interactions with their infants have not been studied yet. In the present study, we propose to evaluate a "SMaRT Mom" intervention that we have developed, to manage and reduce smartphone use during breastfeeding. The purpose of the study is to evaluate the effects of the SMaRT Mom intervention on breastfeeding mothers' biobehavioral mechanisms, self-efficacy and the socioemotional characteristics of their infants. This will extend our knowledge of the peculiarities of early mother-infant interactions in the digital era, when smartphones play a critical role.

研究设计

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

盲法说明

The intervention given to the intervention group will be hidden from participants in the control group, and they will not be asked to refrain from using their smartphones for a week. Participants in the control group will be given information about the intervention week after the second lab visit and allowed to undergo the same intervention the following week.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 3-6 months old infant
  • Smartphone Addiction Scale' cut-off (31 and above)

排除标准

  • No neurological disorders
  • No heart disease
  • No anxiety and depression
  • No use of psychiatric drugs

结局指标

主要结局

Infant temperament

时间窗: Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)

Infants' temperament will be reported by breastfeeding mothers before and after the intervention week using the Infant Behavior Questionnaire - Revised - Very Short Form (IBQ-rvsf). Scale scores represent the mean score of all scale items applicable to the child, as judged by the caregiver. 1. Sum all numerical item responses for a given scale. Note that: a) If caregiver omitted an item, that item receives no numerical score; b) If caregiver checked the "does not apply" response option for an item, that item receives no numerical score; 2. Divide the total by the number of items receiving a numerical response. Not including items marked "does not apply (N/A)" or items receiving no response in determining the number of items. The surgency, negative affect and effortful control subscales' items will be averaged

Maternal self-efficacy

时间窗: Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)

Maternal self-efficacy questionnaire (MSQ) will be self-reported by breastfeeding mothers before and after the intervention week. The scale applies a special method to measure maternal self-efficacy and mostly focuses on a mother's infant care responsibilities. The scale consists of 10 items.Higher score indicates higher maternal self-efficacy

次要结局

  • Self-reported maternal attention towards infant(Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week)
  • Breastfeeding as a rewarding experience(Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week)
  • Changes in breastfeeding mothers' physiological responses - HRV(day 1 and day 8 during lab visits)
  • Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance(day 1 and day 8 during lab visits)
  • Changes in breastfeeding mothers' neural activity - ERP(day 1 and day 8 during lab visits)
  • Changes in breastfeeding mothers' physiological responses - Electrodermal activity(day 1 and day 8 during lab visits)
  • Video recorded maternal attention towards infant(day 1 and day 8 during lab visits)
  • Changes in breastfeeding mothers' neural activity - Frontal asymmetry(day 1 and day 8 during lab visits)

研究者

发起方
Bar-Ilan University, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Ilanit gordon

prof.

Bar-Ilan University, Israel

研究点 (1)

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