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临床试验/NCT04296656
NCT04296656已完成不适用

Mothers' Parenting Satisfaction and Parenting Self-efficacy During the Postpartum Period: An Evaluation of a Infant Calming Method

Tampere University Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年12月3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
250
试验地点
2
主要终点
Parenting satisfaction (PS)

研究概览

简要总结

The main aim of this study is to investigate how to support families with an excessively crying or fussy infant during the first months of the child. The purpose is to discover how an excessively crying or fussy infant affects the mothers' parenting satisfaction and parenting self-efficacy. Furthermore the purpose is to investigate how a behavioral intervention (The 5 S's) affects the infants' mothers' parenting satisfaction and self-efficacy and to evaluate the effectiveness of the intervention.

详细描述

This is a randomized controlled follow-up parallel trial that compares PSE and PS in an intervention and control group. The data was collected during March 1st to May 20th, 2019 from three postpartum wards. The mothers were recruited by midwives on the wards after childbirth. The baseline sample size was 250 mothers, which is based on a conducted power analysis. The sample size calculation was based on previous study, from which the standard deviation (0.81) for change in parental satisfaction was calculated. Baseline data were collected before randomization in the hospital. Follow-up data were collected six to eight weeks postpartum at home.

The instruments to assess the study outcomes were the parenting self-efficacy (PSE) scale developed and validated by Salonen et al. and parenting satisfaction (PS) scale, the evaluation subscale of the questionnaire "What Being the Parent of a New Baby is Like" by Pridham & Chang, 1989.

Data were analyzed with SPSS statistical software for Windows, release 25. Descriptive statistics included frequencies, percentages, means and medians. Total scores for the PSE instrument and WBPL-R evaluation subscale (PS) were calculated by summing the scores for all items and dividing the sum by the number of items. Higher scores indicated better outcomes. Comparisons between groups were made of mother characteristics, PSE and PS. Due to skewed distributions, non-parametric tests were used. Mann-Whitney U tests were used for two group comparisons, and Kruskal Wallis tests were used for three or more group comparisons.

Results have not yet been reported.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Primiparous mothers
  • Multiparous mothers
  • Mothers of healthy infants rooming in (with mother)

排除标准

  • Mothers with infants who were treated on another ward during data collection
  • Mothers with multiple infants
  • Mothers with inability to understand Finnish

结局指标

主要结局

Parenting satisfaction (PS)

时间窗: Baseline

The questionnaire "What Being the Parent of a New Baby is Like" measures parenting satisfaction and has three distinct subscales: evaluation (11 items), centrality (8 items), and life change (6 items). The Evaluation subscale contains 11 items where the mothers responded on a nine-point scale with verbal end anchors, such as 1 = not at all (satisfied) to 9 = completely (satisfied). Higher scores indicate more PS. The evaluation subscale contains items such as "How well do you know your baby?", "How satisfied are you in being a parent of a new baby?" and "How satisfied are you with baby care tasks?".

Change in Parenting satisfaction (PS)

时间窗: 6-8 weeks postpartum

The questionnaire "What Being the Parent of a New Baby is Like" measures parenting satisfaction and has three distinct subscales: evaluation (11 items), centrality (8 items), and life change (6 items). The Evaluation subscale contains 11 items where the mothers responded on a nine-point scale with verbal end anchors, such as 1 = not at all (satisfied) to 9 = completely (satisfied). Higher scores indicate more PS. The evaluation subscale contains items such as "How well do you know your baby?", "How satisfied are you in being a parent of a new baby?" and "How satisfied are you with baby care tasks?".

Parenting Self-Efficacy (PSE)

时间窗: Baseline

This questionnaire measures parenting self efficacy and is domain-specific, and it includes 27 items measuring different infant care skills. These skills are cognitive skills (11 items) such as "I know how to calm a crying baby", affective skills (seven items) such as "I know what my baby enjoys" and behavioural skills (nine items) such as "I'm able to put my baby to sleep". The instrument has a six-point Likert scale 1 = "strongly disagree" to 6 = "strongly agree". Total parenting self-efficacy scores were calculated by adding up the scores of all items and dividing the sum by the number of items. In addition, the score for each subcategory was calculated by adding up the scores of all items in the subcategory and dividing the sum by the number of items. In this instrument, higher scores indicate better outcomes.

Change in Parenting Self-Efficacy (PSE)

时间窗: 6-8 weeks postpartum

This questionnaire measures parenting self efficacy and is domain-specific, and it includes 27 items measuring different infant care skills. These skills are cognitive skills (11 items) such as "I know how to calm a crying baby", affective skills (seven items) such as "I know what my baby enjoys" and behavioural skills (nine items) such as "I'm able to put my baby to sleep". The instrument has a six-point Likert scale 1 = "strongly disagree" to 6 = "strongly agree". Total parenting self-efficacy scores were calculated by adding up the scores of all items and dividing the sum by the number of items. In addition, the score for each subcategory was calculated by adding up the scores of all items in the subcategory and dividing the sum by the number of items. In this instrument, higher scores indicate better outcomes.

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 (2)

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