20 Participants Needed

Mindfulness for Pediatric Chest Pain

SR
Overseen BySonia Research Associate, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Mindfulness is a promising treatment because it helps reduce stress and emotional symptoms like anxiety and sadness. It has been recommended for children with cancer and chronic pain, showing potential benefits in managing symptoms and improving well-being.1591011

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

SS

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

You are willing and able to use the Headspace app every day.
You can answer questions in English.
My main issue is chest pain not caused by heart problems, as confirmed by a heart doctor for children.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Initial Assessment

Participants complete a survey about their sex, ethnicity, and history of chest pain and other chronic pains

0 days
1 visit (in-person)

Randomization and Baseline Surveys

Participants are randomly placed into either the control group or the mindfulness-based intervention group and complete baseline surveys

2 weeks
1 visit (in-person)

Mindfulness-Based Intervention

Participants in the intervention group use the Headspace app for daily mindfulness sessions for 30 days

30 days
Daily virtual sessions

Follow-up

Participants complete final surveys to assess pain coping, perceived stress, quality of life, and mindfulness

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Mindfulness-Based Intervention
Trial Overview The study tests if mindfulness can help kids with unexplained chest pain manage their symptoms better. It checks if it reduces stress, improves life quality, and affects pain frequency/intensity. Kids will either follow standard care or use Headspace for mindfulness sessions.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based InterventionExperimental Treatment1 Intervention
Participants in this arm will partake in a 30 day mindfulness-based intervention on the mobile app Headspace.
Group II: Standard of Care ControlActive Control1 Intervention
Participants in this arm will receive the standard of care. For patients with idiopathic chest pain, the standard of care is typically just reassurance of the benign nature of their pain.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Findings from Research

A mindfulness-based stress reduction (MBSR) program led to significant improvements in self-reported stress levels among pediatric hematology-oncology professionals, with effects lasting for 3 months.
While biological stress markers (hair cortisol concentrations) did not show significant change, self-reported measures of psychological distress, anxiety, depression, and burnout improved notably, especially for those with higher baseline stress levels.
Changes in hair cortisol and self-reported stress measures following mindfulness-based stress reduction (MBSR): A proof-of-concept study in pediatric hematology-oncology professionals.Lamothe, M., Rondeau, É., Duval, M., et al.[2020]
Mindfulness-based stress reduction (MBSR) significantly reduces depression and anxiety in breast cancer patients compared to usual care, based on a systematic review of three randomized controlled trials involving 327 subjects.
While MBSR shows promise in improving psychological health, it does not significantly increase spirituality, indicating that its benefits may be more focused on mental health rather than spiritual well-being.
Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis.Cramer, H., Lauche, R., Paul, A., et al.[2021]
Mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) both show clinically significant benefits in improving physical functioning and reducing pain intensity in patients with chronic pain, based on a review of 21 studies involving over 1,900 participants.
There was no significant difference in effectiveness between MBSR and CBT, suggesting that both therapies are viable options for managing chronic pain, but further research is needed to standardize measures and guide treatment decisions.
Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis.Khoo, EL., Small, R., Cheng, W., et al.[2023]

References

Changes in hair cortisol and self-reported stress measures following mindfulness-based stress reduction (MBSR): A proof-of-concept study in pediatric hematology-oncology professionals. [2020]
Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]
Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. [2023]
[Mindfulness in Trainee Psychotherapies with Children and Adolescents]. [2020]
Mindfulness-based interventions for children and adolescents across all settings: a scoping review protocol. [2021]
Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]
Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. [2022]
Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. [2022]
Mindfulness Practices for Children and Adolescents Receiving Cancer Therapies. [2023]
Mindfulness for adolescent chronic pain: a pilot feasibility study. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. [2018]
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