Determining the Feasibility, Acceptability, and Effectiveness of a Self-Guided Mindfulness-Based Intervention in Pediatric Patients With Idiopathic Chest Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility: Participant Recruitment Rate
研究概览
简要总结
The goal of this clinical trial is to test mindfulness practices in children with idiopathic chest pain, which is chest pain that does not have a known cause. The main question this study aims to answer is whether children who experience idiopathic chest pain are able to follow a mindfulness program. This study also aims to determine whether mindfulness affects the way children with idiopathic chest pain cope, and if it affects their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.
Participants will:
- Complete a survey at the beginning of the study that asks questions about their sex, ethnicity, and history of chest pain and other chronic pains.
- Complete a short survey every day for the entirety of the study that asks about the number, intensity, and duration of chest pain episodes experienced that day.
- Complete 4 surveys, 2 weeks after they have been enrolled in the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey.
- Be randomly placed into either the control group or the mindfulness-based intervention group, 2 weeks after they have been enrolled in the study.
- Receive the standard of care for children with idiopathic chest pain, if they are placed into the control group.
- Use the mobile app Headspace to complete daily mindfulness sessions for the remaining 30 days of the study (starting after the initial 2 week period), if they are placed in the mindfulness-based intervention group.
- Complete 4 surveys at the end of the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey.
- Complete a mindfulness program evaluation survey at the end of the study, only if they are in the mindfulness-based intervention group.
Researchers will collect information from Headspace to see how well participants in the mindfulness-based intervention group are able to follow the mindfulness program. This will help guide future, larger studies that look at the effects of mindfulness-based interventions in children with idiopathic chest pain. Researchers will also compare survey results between the control group and the mindfulness-based intervention group to see if the mindfulness program affects the way children with idiopathic chest pain cope, as well as their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose primary complaint is recurrent chest pain that is diagnosed as idiopathic or musculoskeletal by a pediatric cardiologist.
- •No acute illness.
- •Normal ECG.
- •Willing and able to download and use the Headspace application on a daily basis.
- •Able to complete surveys in the English language.
排除标准
- •Patients whose chest pain is secondary to pericarditis, arrhythmia, or structural heart disease.
- •Patients with concurrent symptoms that could potentially interfere with the ability to determine the effect on their chest pain (e.g., palpitations or dizziness).
- •Unable to provide informed assent.
结局指标
主要结局
Feasibility: Participant Recruitment Rate
时间窗: Baseline (0 days)
The number of patients who consent to participate in the study compared to the number of patients approached about study participation.
Feasibility: Mindfulness-Based Intervention Program Adherence
时间窗: 44 days
Data regarding mindfulness-based intervention program adherence will be collected from Headspace. This includes information about all sessions and length of sessions.
Acceptability: Mindfulness-Based Intervention Program Evaluation
时间窗: 44 days
Data regarding mindfulness-based intervention program evaluation will be collected from the mindfulness program evaluation survey. This survey inquires about duration of the mindfulness program and of daily sessions. It also asks about what participants find most and least useful in the program, as well as what participants want more or less of.
Feasibility: Participant Retention Rate
时间窗: 44 days
The number of participants who remain enrolled in the study for the entirety of the study duration compared to the number of participants who consent to participate in the study.
Feasibility: Survey Response Rate
时间窗: 44 days
The number of surveys completed by participants compared to the number of surveys sent out to be completed.
次要结局
- Chest Pain Episode Intensity(Begin at 0 days, daily up to 44 days)
- Pain Coping Strategies(14 days and 44 days)
- Perceived Stress(14 days and 44 days)
- Patient Quality of Life(14 days and 44 days)
- Chest Pain Episode Frequency(Begin at 0 days, daily up to 44 days)
研究者
Shubhayan Sanatani
Head Division of Cardiology; Professor
University of British Columbia