A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of patients recruited into the study using current inclusion/exclusion criteria
研究概览
简要总结
Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. This study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with three or more miscarriages
- •Women aged >18 years
- •Willing and able to give written consent
排除标准
- •Women will be excluded from this study if they do not speak English well enough to understand and complete study materials. This criterion is in place because the study materials (including PRCI) are not currently available in translation.
研究组 & 干预措施
Intervention group
Will receive the PRCI in addition to the current recommended care pathway
干预措施: Positive Reappraisal Coping Intervention (Other)
Control Group
Will follow the current recommended care pathway
结局指标
主要结局
Number of patients recruited into the study using current inclusion/exclusion criteria
时间窗: Through Study Completion - Average of 1 year
Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?
Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable
时间窗: Through Study Completion - Average of 1 year
How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?
Data collected from questionnaires
时间窗: Through Study Completion - Average of 1 year
Is there a preliminary indication of an effect of the PRCI?
Number of completed questionnaires
时间窗: Through Study Completion - Average of 1 year
Are the proposed study questionnaires and data collection methods appropriate?
次要结局
- Data Collected from questionnaires(Through Study Completion - Average of 1 year)