ChiCTR2600132915尚未招募Unknown
Feasibility and Acceptability of Cognitive Behavioural Stress Management Intervention (JoyMUM) for Pregnant Women: A Pilot Randomised Controlled Trial
适应症
干预措施
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- Self-funded
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
To assess the feasibility and acceptability of the JoyMUM intervention among pregnant women and to identify potential challenges to inform refinement of the study procedures and intervention content. Additionally, this study aims to explore preliminary changes in stress outcomes and stress-related factors to support the planning of a future definitive trial.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The outcome assessor will be blinded.
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- Female
入选标准
- •Women will be recruited based on the following inclusion criteria:
- •1.Aged over 18 years;
- •2.Currently pregnant with a gestation age of 25-29 weeks;
- •3.Regardless of parity and gravidity;
- •4.Planning to deliver in Hong Kong;
- •5.Able to read and write in English, Traditional Chinese, or Simplified Chinese; and
- •6.Having access to social media (WhatsApp/WeChat/Instagram) and online conference platforms (Zoom/VooV Meeting) with internet access.
排除标准
- •Participants will be excluded if they:
- •1.Are under 25 weeks’ gestation, due to higher risk of early pregnancy loss and uncertainty about fetal viability, or over 29 weeks’ gestation, when there may be too little time before labour to complete the intervention and follow-up;
- •2.Carry an abnormal infant;
- •3.Have complicated medical problems; or
- •4.Cannot speak or read English, Cantonese, or Mandarin.
研究组 & 干预措施
Intervention group
JoyMUM cognitive behavioural stress management
干预措施: JoyMUM cognitive behavioural stress management
Control group
Alternative control, Health information regarding oral hygiene during pregnancy
干预措施: Alternative control, Health information regarding oral hygiene during pregnancy
结局指标
主要结局
Feasibility
Acceptability
次要结局
- Pregnancy-specific stress symptoms
- Generic stress symptoms
- Automatic thoughts
- Sleep problems
- Anxiety symptoms
研究者
研究点 (1)
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