A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quality of Life in Epilepsy
研究概览
简要总结
This study's proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, effects on quality of life-related to epilepsy, symptoms of depression and anxiety, perceived stress, and feelings of empowerment.
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
- •at least 18 years of age
- •currently pregnant and primiparous
- •able to provide informed consent
- •able to have internet access
- •have a confirmed diagnosis of epilepsy based on EEG or clinical evidence
排除标准
- •need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician
- •prior involvement in the Lullaby Project
研究组 & 干预措施
Control
Lullaby Project
Participants assigned to the intervention group will meet virtually with a professional musician for 5-7 sessions over the course of 10 weeks. Each session will last approximately 1.5 hours and will be conducted via Zoom.
干预措施: Lullaby Project (Behavioral)
结局指标
主要结局
Quality of Life in Epilepsy
时间窗: 6 months
Assess quality of life related to epilepsy (via QOLIE-31-P, the Patient-Weighted Quality of Life in Epilepsy inventory); minimum value is 0 and maximum value is 100. Higher scores represent better quality of life.
次要结局
- Depression and Anxiety(6 months)
- Pregnancy-related Empowerment(6 months)
- Feasibility and Acceptability(12 months)
研究者
Esther Bui
Assistant Professor, MD FRCPC
University Health Network, Toronto