Mindfulness for Pediatric Chest Pain
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the study focuses on mindfulness practices and does not mention medication changes.
What data supports the idea that Mindfulness for Pediatric Chest Pain is an effective treatment?
The available research shows that mindfulness-based interventions (MBIs) can be effective for children and adolescents. One study found that both mindfulness and relaxation interventions worked well with young patients, suggesting that mindfulness can help improve their mental health. Although there is no specific data on pediatric chest pain, mindfulness has been shown to reduce stress and improve well-being in other conditions, like chronic pain and breast cancer. This suggests that mindfulness could also be beneficial for managing chest pain in young people.12345
What safety data exists for mindfulness-based treatments?
The research indicates that mindfulness-based interventions (MBIs) like Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR) are widely used in various populations, including adolescents and adults with psychiatric disorders. While there is little focus on adverse effects, MBIs are generally considered effective for improving mental health outcomes and reducing stress. Studies have shown positive results in treating conditions like tension headaches and stress in healthcare professionals, and they are being increasingly implemented in therapies for children and adolescents. However, specific safety data on adverse effects is limited.14678
Is mindfulness a promising treatment for pediatric chest pain?
What is the purpose of this trial?
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.
Research Team
Shubhayan Sanatani, MD
Principal Investigator
British Columbia Children's Hospital
Eligibility Criteria
This trial is for children with idiopathic or musculoskeletal chest pain, as diagnosed by a pediatric cardiologist. They should have no acute illness and a normal ECG. Participants must be willing to use the Headspace app daily and complete surveys in English.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Participants complete a survey about their sex, ethnicity, and history of chest pain and other chronic pains
Randomization and Baseline Surveys
Participants are randomly placed into either the control group or the mindfulness-based intervention group and complete baseline surveys
Mindfulness-Based Intervention
Participants in the intervention group use the Headspace app for daily mindfulness sessions for 30 days
Follow-up
Participants complete final surveys to assess pain coping, perceived stress, quality of life, and mindfulness
Treatment Details
Interventions
- Mindfulness-Based Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor