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临床试验/NCT06237088
NCT06237088Unknown不适用

Mother-infant Connection Strategy Program: Impact on Psychological Distress and Mother-infant Bonding in Women

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2023年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
142
试验地点
1
主要终点
anxiety

研究概览

简要总结

This study evaluated the long-term effects of an online mindfulness-based program on the psychological distress and mother-infant bonding of women

详细描述

The aim of this study was to test the efficacy of an online mindfulness program in reducing women's perceived stress, anxiety, depression, and in enhancing mindfulness and mother-infant bonding compared to a control group. The investigators hypothesize that the use of an online mindfulness program or an eight-week mindfulness program by the two experimental groups will lead to improved mood symptoms and mother-infant bonding compared with the control group.

A randomized controlled trial comparing three groups of healthy, singleton pregnant women was conducted using the Random Allocation Software (Saghaei, 2004). We used G-Power 3.1.9 for Windows to analyze the minimum effect size that would be statistically significant with an 80% probability, using an alpha error probability of 0.05 in the "ANOVA: Repeated measures, between factors" option. We inputted 3 for the number of groups, 4 for the number of measurements, 0.5 for the correlation between repeated measures, and factored in a 20% attrition rate. There are 41 women in each group.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • •Subjects were at the age over 18
  • •Could speak and read Chinese fluently
  • •Willing and be ale to attend the education program

排除标准

  • •Taking medication for diagnosing mental illness
  • •With complicated or high-risk pregnancies

研究组 & 干预措施

eight-week mindfulness programs

Active Comparator

The intervention consists of 2.5-hour classes per week over a period of eight weeks.

干预措施: eight-week mindfulness programs (Other)

online mindfulness program

Experimental

The intervention includes an eight-week internet-based mindfulness program. The program introduces participants to a new mindfulness topic every week. These topics are heavily inspired by the eight-week mindfulness programs.

干预措施: online mindfulness program (Other)

care as usual

No Intervention

Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

结局指标

主要结局

anxiety

时间窗: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety.

depression

时间窗: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

Edinburgh Perinatal Depression Scale, that was 10-question questionnaire provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total score

mother-infant bonding

时间窗: the follow-up at 2 , 4 months postpartum.

The Postpartum Bonding Questionnaire, that was 25 items, with four factors. The first factor was labelled general emotional factor, the second anger towards and rejection of baby; the third infant-focus anxiety; and the fourth, risk of abuse.

mindfulness

时间窗: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

The Five Facet Mindfulness Questionnaire, that was 39-item is based on factor analysis. The five facets of the FFMQ include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scoring uses a 5-point Likert scale, with 1 representing "never or very rarely true" and 5 representing "very often or always true"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wan-Lin Pan

Assistant Professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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