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Mindfulness for Pediatric Chest Pain

N/A

Recruiting

Led By Shubhayan Sanatani, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients whose primary complaint is recurrent chest pain that is diagnosed as idiopathic or musculoskeletal by a pediatric cardiologist.

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days and 44 days

Awards & highlights

Study Summary

This trial tests mindfulness practices in children with idiopathic chest pain to see if it affects how they cope & their stress, QoL, & chest pain occurrence & intensity.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-invasive mindfulness practices through an app, there are no direct medical side effects expected from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My main issue is chest pain not caused by heart problems, as confirmed by a heart doctor for children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days and 44 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days and 44 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days and 44 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability: Mindfulness-Based Intervention Program Evaluation

Feasibility: Mindfulness-Based Intervention Program Adherence

Feasibility: Participant Recruitment Rate

+2 more

Secondary outcome measures

Chest Pain Episode Frequency

Chest Pain Episode Intensity

Pain Coping Strategies

+2 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Based Intervention

2020

N/A

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,467,098 Total Patients Enrolled

1 Trials studying Chest Pain

150 Patients Enrolled for Chest Pain

Shubhayan Sanatani, MDPrincipal InvestigatorBritish Columbia Children's Hospital

4 Previous Clinical Trials

486 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial restricted to individuals younger than eighty years of age?

"As indicated by the requirements for this trial, minors between 12 and 18 years of age are eligible to take part."

Answered by AI

What is the objective of this clinical investigation?

"This clinical trial, lasting around 44 days, aims to assess the effectiveness of a Mindfulness-Based Intervention Program. Secondary objectives include measuring levels of Perceived Stress (assessed using the PSS-10 questionnaire), Chest Pain Episode Intensity (using Wong-Baker FACES Pain Rating Scale) and Chest Pain Episode Frequency (via survey)."

Answered by AI

Are there still openings for participants in this clinical experiment?

"According to the clinicaltrials.gov website, this investigation is still actively looking for volunteers. Originally posted on December 1st 2023 and updated November 28th 2023, it's clear that recruitment efforts are ongoing."

Answered by AI

What is the aggregate number of participants involved in this trial?

"Affirmative, the details hosted on clinicaltrials.gov confirm that this medical experiment is actively seeking participants. This investigation was first posted on December 1st 2023 and its most recent update came on November 28th 2023; currently they are attempting to enroll twenty patients from one site."

Answered by AI

Is enrolment still possible for this trial?

"This investigation is looking for 20 adolescents between 12 and 18 years of age who suffer from chest pains. Those hoping to take part must meet the following standards: Possess a cardiologist-confirmed diagnosis of either idiopathic or musculoskeletal chest pain; have no current illnesses; possess normal ECG results, be able and willing to daily utilize Headspace App on their devices; and demonstrate proficiency in English when completing surveys."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mindfulness for Pediatric Chest Pain

Shubhayan Sanatani 2023. "Mindfulness for Pediatric Chest Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05939492.