Mindfulness-based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Pain interference
研究概览
简要总结
This study examines the efficacy of a mindfulness-based intervention designed to support pain and sleep management in adolescents and young adults with sickle cell disease. Participants will be assigned to either an intervention or usual care group. Participants who are assigned to the intervention group will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period.
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
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 15-39 years
- •Have been diagnosed with SCD
- •Are able to speak and understand English
- •Are able to complete questionnaires with minimal or no assistance from a caregiver
- •Report pain and/or sleep problems as assessed by the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) short forms
- •Have access to the internet on a smartphone, tablet, or computer
排除标准
- •Individuals who have significant cognitive limitations that will impair their ability to use and understand the MBI, as per their health care provider or caregiver
- •Are currently receiving an MBI or have received more than 4 sessions of any MBI in the 6 months prior to the screening
研究组 & 干预措施
Mindfulness-based intervention
Participants who are assigned to an intervention group receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks.
干预措施: Mindfulness-based intervention (Behavioral)
Usual care group
Participants who are assigned to a usual care group receive usual care over approximately 8 weeks.
结局指标
主要结局
Pain interference
时间窗: At 8 weeks
Pain interference will be measured using Brief Pain Inventory (higher scores indicating greater pain-related interference).
次要结局
- Pain intensity(At 8 weeks)
- Physical function(At 8 weeks)
- Pain catastrophizing(At 8 weeks)
- Sleep disturbance(At 8 weeks)
- Fatigue(At 8 weeks)
- Anxiety(At 8 weeks)
- Depression(At 8 weeks)
- Intention(At 8 weeks)
- Dose intensity(At 8 weeks)
研究者
Dahee Wi
Assistant Professor
University of Illinois at Chicago