Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05939492
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-06-22
Brief Title:
Mindfulness for Pediatric Chest Pain
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Determining the Feasibility Acceptability and Effectiveness of a Self-Guided Mindfulness-Based Intervention in Pediatric Patients With Idiopathic Chest Pain A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None