A Randomized Controlled Trial of a Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Preparation for Decision Making (PrepDM) score
研究概览
简要总结
Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Digital tools can support SDM by providing accessible, evidence-based information.
The Society for Obstetric Anesthesia and Perinatology (SOAP) is an international organization made up of doctors who specialize in managing pain and anesthesia during pregnancy. Their focus is the wellbeing and safety of mothers and their babies from early pregnancy through delivery and recovery. The Painless Push digital resource educates mothers about ways to manage pain during labour.
This trial aims to evaluate whether directing patients to access to the website https://thepainlesspush.com/ improves preparedness for shared decision-making compared to the current care, which is access to the Mount Sinai Obstetric Anesthesia website.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant individuals ≥ 18 years
- •Visiting OB clinic at Mount Sinai hospital during their 3rd trimester of pregnancy (≥ 28 weeks gestation)
- •Singleton gestation
- •Nulliparous
- •Considering labour epidural analgesia for childbirth
排除标准
- •Sensory, cognitive, or language barriers precluding participation
- •Limited English proficiency
研究组 & 干预措施
Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website
Comparator: The Painless Push digital resource educates mothers about ways to manage pain during labour.
干预措施: Preparation for Decision Making (PrepDM) Scale (Other)
Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website
Comparator: The Painless Push digital resource educates mothers about ways to manage pain during labour.
干预措施: Questionnaire (Other)
Mount Sinai Obstetric Anesthesia website
Control group: website currently available to patients.
干预措施: Preparation for Decision Making (PrepDM) Scale (Other)
Mount Sinai Obstetric Anesthesia website
Control group: website currently available to patients.
干预措施: Questionnaire (Other)
结局指标
主要结局
Preparation for Decision Making (PrepDM) score
时间窗: Immediately following intervention (reading material)
PrepDM is a 10-item validated tool scored from 0 to 100. Higher scores reflect greater readiness for informed and shared decision-making
次要结局
- Questionnaire - additional questions about digital material provided(Immediately following intervention (reading material))