Chest PainNCT05939492
Mindfulness for Pediatric Chest Pain
A study testing Mindfulness-Based Intervention in people with Chest Pain, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
Sonia Franciosi, PhD
About this study
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
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:
Read more
- 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
- Being tested
- Mindfulness-Based Intervention
- Keywords
- Pediatrics, Idiopathic, Chest Pain
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 44 days
Feasibility: Survey Response Rate
The number of surveys completed by participants compared to the number of surveys sent out to be completed.
Measured: 44 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Begin at 0 days, daily up to 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start25 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shubhayan Sanatani, University of British Columbia
- Investigators
- Shubhayan Sanatani, MD, Principal investigator, British Columbia Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939492
- Sponsor's protocol ID
- H23-00137
- Status last verified
- May 2024
- First submitted
- 22 Jun 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05939492
- Acronym / sponsor ID
- H23-00137
- Conditions
- Chest Pain
- Keywords
- Pediatrics, Idiopathic, Chest Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Mindfulness-Based InterventionParticipants in this arm will partake in a 30 day mindfulness-based intervention on the mobile app Headspace. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based InterventionParticipants 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. | Behavioural | Mindfulness-Based Intervention |
Primary outcome
Feasibility: Participant Recruitment Rate
Time frame: Baseline (0 days)
The number of patients who consent to participate in the study compared to the number of patients approached about study participation.
Feasibility: Participant Retention Rate
Time frame: 44 days
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.
Feasibility: Mindfulness-Based Intervention Program Adherence
Time frame: 44 days
Data regarding mindfulness-based intervention program adherence will be collected from Headspace. This includes information about all sessions and length of sessions.
Acceptability: Mindfulness-Based Intervention Program Evaluation
Time frame: 44 days
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.
Feasibility: Survey Response Rate
Time frame: 44 days
The number of surveys completed by participants compared to the number of surveys sent out to be completed.
5 secondary outcomes
Pain Coping Strategies
Time frame: 14 days and 44 days
Perceived Stress
Time frame: 14 days and 44 days
Patient Quality of Life
Time frame: 14 days and 44 days
Chest Pain Episode Frequency
Time frame: Begin at 0 days, daily up to 44 days
Chest Pain Episode Intensity
Time frame: Begin at 0 days, daily up to 44 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubhayan Sanatani, MD principal investigator
British Columbia Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention in people with Chest Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Research Associate, PhD (604-875-2345 ext. 7955, sonia.franciosi@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Participant Recruitment Rate (time frame: Baseline (0 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.