Mindfulness for Pediatric Chest Pain

Determining the Feasibility, Acceptability, and Effectiveness of a Self-Guided Mindfulness-Based Intervention in Pediatric Patients With Idiopathic Chest Pain: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chest Pain
• Intervention / Treatment: Behavioral: Mindfulness-Based Intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonia Research Associate, PhD; Phone Number: 7955 604-875-2345; Email: sonia.franciosi@cw.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Recruiting
      • BC Children's Hospital
      • Contact: Sonia Franciosi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Control; 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.
Experimental: Mindfulness-Based Intervention; Participants in this arm will partake in a 30 day mindfulness-based intervention on the mobile app Headspace.	Behavioral: Mindfulness-Based Intervention; Participants in the mindfulness-based intervention (MBI) group will be asked to use the Headspace app to sequentially complete the "Basics", "Basics 2", and "Basics 3" courses. Each of these courses lasts 10 days, and participants have the ability to choose how long daily sessions last. Participants can choose between 3, 5, or 10-minute sessions for the "Basics" course; 10 or 15-minute sessions for the "Basics 2" course; and 10, 15, or 20-minute sessions for the "Basics 3" course. These daily sessions are audio recordings that prompt users to engage in a variety of mindfulness techniques, including focusing on their body and breathing, as well as acknowledging thoughts and emotions in a non-judgmental manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Participant Recruitment Rate	The number of patients who consent to participate in the study compared to the number of patients approached about study participation.	Baseline (0 days)
Feasibility: Participant Retention Rate	The number of participants who remain enrolled in the study for the entirety of the study duration compared to the number of participants who consent to participate in the study.	44 days
Feasibility: Mindfulness-Based Intervention Program Adherence	Data regarding mindfulness-based intervention program adherence will be collected from Headspace. This includes information about all sessions and length of sessions.	44 days
Acceptability: Mindfulness-Based Intervention Program Evaluation	Data regarding mindfulness-based intervention program evaluation will be collected from the mindfulness program evaluation survey. This survey inquires about duration of the mindfulness program and of daily sessions. It also asks about what participants find most and least useful in the program, as well as what participants want more or less of.	44 days
Feasibility: Survey Response Rate	The number of surveys completed by participants compared to the number of surveys sent out to be completed.	44 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Coping Strategies	Pain coping strategies will be assessed by having participants complete the Pediatric Quality of Life Inventory Pediatric Pain Coping Inventory (PedsQL PPCI). This questionnaire is comprised of 41 items, with scores transformed on a scale from 0 (never) to 2 (often). The minimum score is 0 and the maximum is 82. A higher score indicates a greater use of pain coping strategies.	14 days and 44 days
Perceived Stress	Perceived stress will be assessed by having participants complete the Perceived Stress Scale (PSS-10). This questionnaire is comprised of 10 items. The minimum score is 0 and the maximum is 40. A higher score indicates a higher level of perceived stress.	14 days and 44 days
Patient Quality of Life	Quality of life will be assessed by having participants complete the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale. This questionnaire is comprised of 23 items which are reverse scored and linearly transformed to a 0-100 scale as follows: 0 (never) = 100; (almost never) = 75; (sometimes) = 50; (often) = 25; (almost always) = 0 The minimum score is 0 and the maximum is 2300. A higher score indicates a better health-related quality of life.	14 days and 44 days
Chest Pain Episode Frequency	Frequency of chest pain episodes will be assessed by having participants complete the chest pain episodes survey that inquires about how many chest pain episodes they had that day.	Begin at 0 days, daily up to 44 days
Chest Pain Episode Intensity	Intensity of chest pain episodes will be assessed by having participants complete the chest pain episodes survey that inquires about the average intensity of chest pain episodes they had that day. Intensity will be rated using the Wong-Baker FACES Pain Rating Scale.	Begin at 0 days, daily up to 44 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Shubhayan Sanatani, MD, British Columbia Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pediatrics; Chest Pain; Idiopathic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: H23-00137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No