Mindfulness for Pediatric Chest Pain

NCT05939492 | Recruiting

• 1 other identifier: H23-00137
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

Pediatrics; Idiopathic; Chest Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Pain Coping Strategies

  14 days and 44 days

• Perceived Stress

  14 days and 44 days

• Patient Quality of Life

  14 days and 44 days

• Chest Pain Episode Frequency

  Begin at 0 days, daily up to 44 days

• Chest Pain Episode Intensity

  Begin at 0 days, daily up to 44 days

Study Arms (2)

Standard of Care Control

NO 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.

Mindfulness-Based Intervention

EXPERIMENTAL

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

Behavioral: Mindfulness-Based Intervention

Interventions

Mindfulness-Based Intervention BEHAVIORAL

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.

Mindfulness-Based Intervention

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shubhayan Sanatani, MD

  British Columbia Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Research Associate, PhD

CONTACT

604-875-2345; sonia.franciosi@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division of Cardiology; Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 11, 2023
• Study Start: March 25, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CA (1)