Clinical trial NCT05939492: Mindfulness for Pediatric Chest Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
Keywords: Pediatrics
Idiopathic
Chest Pain
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After a 2-week wash-in period, study participants will be randomly assigned to either the standard of care control group or the mindfulness-based intervention group.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients whose primary complaint is recurrent chest pain that is diagnosed as idiopathic or musculoskeletal by a pediatric cardiologist.
* No acute illness.
* Normal ECG.
* Willing and able to download and use the Headspace application on a daily basis.
* Able to complete surveys in the English language.

Exclusion Criteria:

* Patients whose chest pain is secondary to pericarditis, arrhythmia, or structural heart disease.
* Patients with concurrent symptoms that could potentially interfere with the ability to determine the effect on their chest pain (e.g., palpitations or dizziness).
* Unable to provide informed assent.

Primary outcomes:
measure: Feasibility: Participant Recruitment Rate
timeFrame: Baseline (0 days)
measure: Feasibility: Participant Retention Rate
timeFrame: 44 days
measure: Feasibility: Mindfulness-Based Intervention Program Adherence
timeFrame: 44 days
measure: Acceptability: Mindfulness-Based Intervention Program Evaluation
timeFrame: 44 days
measure: Feasibility: Survey Response Rate
timeFrame: 44 days
Secondary outcomes:
measure: Pain Coping Strategies
timeFrame: 14 days and 44 days
measure: Perceived Stress
timeFrame: 14 days and 44 days
measure: Patient Quality of Life
timeFrame: 14 days and 44 days
measure: Chest Pain Episode Frequency
timeFrame: Begin at 0 days, daily up to 44 days
measure: Chest Pain Episode Intensity
timeFrame: Begin at 0 days, daily up to 44 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: British Columbia Children's Hospital
name: Shubhayan Sanatani, MD
role: PRINCIPAL_INVESTIGATOR
References: