Mindfulness for Pediatric Chest Pain

Overseen By Sonia Research Associate, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Pericarditis, Arrhythmia, Structural heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether mindfulness practices can help children who experience idiopathic chest pain. Researchers seek to determine if these children can follow a mindfulness program and how it affects their pain coping, stress levels, quality of life, and the frequency and intensity of their chest pain. Participants will be divided into two groups: one will continue with their usual care, while the other will use a mindfulness app called Headspace for 30 days. Children who frequently experience chest pain without an identified cause and are comfortable using a mobile app might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how mindfulness can improve children's well-being.

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 prior data suggests that mindfulness practices are safe for children with idiopathic chest pain?

Research has shown that mindfulness practices are generally safe and manageable for most people. One study found that a mindfulness-based stress reduction program significantly lowered stress levels in children across various situations, suggesting that kids can engage in mindfulness exercises without major issues.

Another study examined mindfulness in individuals with ongoing pain and found it greatly reduced anxiety and improved mindfulness. There was also a trend toward reducing depression and easing chest pain, indicating that mindfulness could safely help manage symptoms without harmful side effects.

To date, no serious negative effects have been reported from using mindfulness programs, making them a promising option for managing symptoms like chest pain in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a mindfulness-based intervention for pediatric chest pain because it offers a non-invasive and holistic approach to managing symptoms. Unlike the standard of care, which typically involves just reassuring patients about the non-threatening nature of idiopathic chest pain, this approach uses mindfulness practices to potentially reduce pain perception and improve overall well-being. The intervention is delivered through the mobile app Headspace, making it easily accessible and convenient for young patients and their families to integrate into their daily routines. This method could provide a valuable alternative or complement to existing treatments by targeting the psychological aspects of pain.

What evidence suggests that mindfulness might be an effective treatment for idiopathic chest pain?

Research shows that mindfulness activities can help manage stress and pain. In past studies, mindfulness programs significantly reduced stress in children with long-term pain. For example, one study found that a mindfulness program lowered anxiety in patients with ongoing chest pain not related to the heart. Mindfulness practices have also improved coping skills and quality of life in teenagers. In this trial, participants in the Mindfulness-Based Intervention arm will engage in a 30-day mindfulness program using the mobile app Headspace. These findings suggest that mindfulness could help children with unexplained chest pain manage stress and better handle their condition. ^{2 4 5 6 7}

Who Is on the Research Team?

Shubhayan Sanatani, MD

Principal Investigator

British Columbia Children's Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Mindfulness-Based Intervention Experimental Treatment 1 Intervention

Participants in this arm will partake in a 30 day mindfulness-based intervention on the mobile app Headspace.

Group II: Standard of Care Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

An 8-week mindfulness-based intervention (MBI) was found to be feasible for adolescents aged 14-17 with chronic pain, with high attendance rates and no dropouts, indicating good acceptability.

Participants experienced significant reductions in pain intensity that were maintained at a three-month follow-up, suggesting that MBIs could be a promising alternative treatment for chronic pain in youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness for adolescent chronic pain: a pilot feasibility study. Lovas, DA., Pajer, K., Chorney, JM., et al.[2018]

In a randomized clinical trial involving 60 patients with tension-type headaches, mindfulness-based stress reduction (MBSR) significantly decreased perceived stress and improved mental health, as measured by the Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS).

The MBSR group showed a substantial reduction in BSI scores from 1.63 to 0.73 after the intervention, and perceived stress scores decreased from 16.96 to 12.7, indicating that MBSR is an effective treatment for managing stress and mental health in headache patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. Omidi, A., Zargar, F.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Cramer, H., Lauche, R., Paul, A., et al.[2021]

This review aims to synthesize existing literature on mindfulness-based interventions (MBIs) for children and adolescents, highlighting their application for both healthy individuals and those with various disorders, which is still a developing field.

The study will provide a comprehensive overview of MBI methodologies and outcomes, helping to identify trends and gaps in research, ultimately guiding future studies to enhance the effectiveness of mindfulness practices in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for children and adolescents across all settings: a scoping review protocol. Perrier, MF., Gurgel-Juarez, N., Flowers, HL., et al.[2021]

An 8-week mindfulness-based intervention adapted for adolescents with chronic pain (MBI-A) was found to be feasible and well-received, with a high treatment completion rate of 90.5% among 21 participants.

Participants showed significant improvements in pain acceptance and coping skills, indicating that MBI-A may be an effective approach for managing chronic pain in pediatric populations, warranting further research through randomized-controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. Ruskin, DA., Gagnon, MM., Kohut, SA., et al.[2018]

Mindfulness-based interventions (MBIs) are increasingly being integrated into cognitive-behavioral therapy for children and adolescents, but research on their specific implementation in individual therapy is still limited.

The 'Mindfulness and Relaxation Study - Children and Adolescents' (MARS-CA) is examining the effects of mindfulness and relaxation interventions on young patients' symptoms and therapeutic relationships, with preliminary results indicating that both types of interventions are effective with juvenile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in Trainee Psychotherapies with Children and Adolescents]. Kalmar, J., Engel, S., Baumann, I., et al.[2020]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness-based interventions (MBIs) can help alleviate symptoms such as fatigue, anxiety, sadness, and anger in children with cancer, making them a valuable addition to treatment plans.

Various MBIs, including mindful movement and breath awareness, can be easily adapted for different ages and have been implemented with minimal training, suggesting they can be integrated into pediatric oncology care effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Practices for Children and Adolescents Receiving Cancer Therapies. Murphy, S., Donma, AJ., Kohut, SA., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in mindfulness and self-esteem, indicating its potential effectiveness.

Both adolescents and their parents reported improvements in functioning, suggesting that the intervention is not only feasible and acceptable but also beneficial for mental health, warranting further research in a randomized controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. Tan, L., Martin, G.[2022]

Citations

1. withpower.com withpower.com/trial/phase-chest-pain-6-2023-58272

Mindfulness for Pediatric Chest Pain A mindfulness-based stress reduction (MBSR) program led to significant improvements in self-reported stress levels among pediatric hematology-oncology ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04151121

Study Details | NCT04151121 | Mindfulness in Chest Pain MBCT is recognized behavior therapy for patients with recurrent depression. The program will be adapted for patients with chest pain. Participant Group/Arm, No ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9096570/

Mindfulness-based intervention in patients with persistent ... One-third of patients with persistent non-cardiac chest pain were willing to participate in mindfulness-based therapy. An improvement in anxiety ...

4. scholarsarchive.library.albany.edu scholarsarchive.library.albany.edu/cgi/viewcontent.cgi?article=1117&context=etd

The Effects of Mindfulness on Chronic Pain in Children and ... Preliminary results of mindfulness-based interventions and programs suggest that they positively impact students' cognitive, emotional, and interpersonal ...

5. jpedhc.org jpedhc.org/article/S0891-5245(17)30634-X/pdf

Mindfulness-Based Interventions Among Adolescents With ... MBSR is an evidence-based 8-week program that aims to reduce stress and improve coping skills through training in formal mindfulness practices.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05939492

NCT05939492 | Mindfulness for Pediatric Chest Pain 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 ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05939492/mindfulness-for-pediatric-chest-pain

Mindfulness for Pediatric Chest Pain This study also aims to determine whether mindfulness affects the way children with idiopathic chest pain cope, and if it affects their stress ...