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临床试验/ChiCTR-TRC-13004070
ChiCTR-TRC-13004070已完成不适用

促進準父母心理健康計劃

Health and Medical Research Fund, Food & Health Bureau, The Government of Hong Kong SAR1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2015年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
178
试验地点
1
主要终点
Self-reported Mental Component Scale (MCS-12)

研究概览

简要总结

促進準父母心理健康計劃

研究设计

研究类型
干预性研究
主要目的
随机平行对照

入排标准

年龄范围
18 至 50(—)
性别
Female

入选标准

  • (1) currently with a singleton pregnancy at 14–20 weeks of gestation (intervention starts at 20–25 weeks of gestation);
  • (2) being a resident of Hong Kong who will be living in Hong Kong for at least one year after childbirth;
  • (3) being able to communicate in Cantonese (group sessions will be conducted in Cantonese);
  • (4) being able to give informed consent;
  • (5) having no previous experience with meditation;
  • (6) having no daily practice with other mind–body techniques (e.g. yoga, tai-chi); and
  • (7) being willing and able to attend all the sessions.

排除标准

  • (1) being a woman who does not meet all of the inclusion criteria;
  • (2) having a concurrent DSM-IV Axis diagnosis or recent diagnosis of depression during the last 12 months; and
  • (3) currently seeing a psychiatrist or mental health professional or receiving any form of treatment for any mental condition.

研究组 & 干预措施

Two groups

Mindfulness education versus Antenatal Childbirth Education and Support (ACES).

Description

Mindfulness is a set of contemplative skills that cultivate non-judgemental moment-to-moment awareness, acceptance and non-avoidance of one’s present inner experience. Mindfulness is systematically taught over eight to ten weeks by group educational classes.

(continue)

Mindfulness-based Childbirthing & Parenting (MBCP) is a nine-week antenatal programme with training in mindfulness through various activities such as mindful awareness of the breath, body, feelings, thoughts, and emotions;

结局指标

主要结局

Self-reported Mental Component Scale (MCS-12)

时间窗: This outcome is measured 4 times: before the intervention (T1), after the intervention (T2), at the six to eight weeks postpartum visit (T3), and the reunion at six months after childbirth (T4).

次要结局

  • 1.SF-12; Chinese (HK specific)
  • 2. Depression measured by the validated Hong Kong Chinese version of the Edinburgh Postnatal Depression Scale (EPDS).
  • 3. Perceived Stress measured by the self-reported Hong Kong Chinese version 14-item Global Measure of Perceived Stress Scale (PSS-14)
  • 4. Mindfulness level measured by the Hong Kong Chinese version self-reported 39-item Five Facets Mindfulness Questionnaire (FFMQ-C).
  • 5.5 Center for Epidemiologic Studies Depression Scale_Eng (CES-D)
  • 6.Multidimensional Assessment of Interceptive Awareness _Eng (MAIA)
  • 7.Pain Catastrophizing Scale_Eng (PCS)
  • 8.Prenatal Pregnancy Anxiety _Eng (PPA)
  • 9.State-Trait Anxiety Inventory_Eng (STAI)
  • 10.Pain Visual Analogue Scale _Eng
  • 11.Satisfaction with Childbirth experience(These outcomes are measured 4 times: before the intervention (T1), after the intervention (T2), at the six to eight weeks postpartum visit (T3), and the reunion at six months after childbirth (T4).)

研究者

发起方
Health and Medical Research Fund, Food & Health Bureau, The Government of Hong Kong SAR

研究点 (1)

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