Testing Parent-child yoga for congenital heart disease
Official title: A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial
- 2 groups
- 2 sites in Montreal
- Recruiting
Interventions
- Behavioural therapy
Parent-child yoga
The 45-minute yoga sessions are structured to include an opening and a closing ritual that remain the same throughout the 8 weeks, between which an active and a calming parts are scheduled. The active and calming parts are embedded in stories that align with the developmental level and interests typical of 4-to-6-year-olds. Each session is clearly structured with each exercise and transition well described in the Yoga for Little Hearts Yoga Program Manual. In addition to the yoga sessions, at-home exercises (5 min) including breathing, meditation and mindfulness activities will be explained to participants. We will ask them to practice them at home at least 3 times every week, for the 8-week duration of the intervention. Including the yoga session and home exercises, the 8-week intervention thus includes at least 60 minutes of yoga per week. Parents will be encouraged to pursue the at-home exercises after the end of the 8-week yoga program, up to the 6-month follow-up.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec
- Recruiting
Centre universtaire de santé McGill
Montreal, Quebec
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +aged 4 to 6 years old;
- +poor attentional skills measured with Variability score (0.5 standard deviation below norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a sensitive measure for attentional impairments. This inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → is important since yoga intervention has shown larger effects on attention in children with greater difficulties before the intervention;
- +parent willing to participate to the 8-week parent-child yoga intervention and the pre/post/6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → assessments;
- +for children with ADHD medication (approx. 5% of the 4-to-6-year-olds at our neurocardiac clinic), parent accept to temporary stop it to at least 48h prior to each assessment.
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → will be the following:
- +having a medical contraindication to the practice of yoga;
- +confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing;
- +presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation;
- +families who do not speak French or English (less than 3% of families followed in our clinics);
- +children who have been engaged in a structured weekly yoga program for at least a month in the past year (based on our parents' poll, less than 5%). However, parents included could have past or actual experience in practicing yoga.
- +EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → will be determined:
- +by consulting the child's medical record;
- +during a child medical visit at one of the sites or a virtual visit with the research team by administering the K-CPT2.
- +diagnosis of CHD requiring heart surgery;
Exclusion
- −will be the following:
- −having a medical contraindication to the practice of yoga;
- −confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing;
- −presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation;
- −families who do not speak French or English (less than 3% of families followed in our clinics);
- −children who have been engaged in a structured weekly yoga program for at least a month in the past year (based on our parents' poll, less than 5%). However, parents included could have past or actual experience in practicing yoga.
- −EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → will be determined:
- −by consulting the child's medical record;
- −during a child medical visit at one of the sites or a virtual visit with the research team by administering the K-CPT2.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Parent-child yoga.
Registry label: A: Yoga group
Group B receives no study treatment and is followed for comparison.
Registry label: B: Waitlist control group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 4 years to 6 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 24 people.
The study is currently expected to finish around October 2025.
The main measurement is taken over: 2 months prior to the intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recruitment rate — measured over 2 months prior to the intervention.
Dropout and withdrawal rates — measured over The 8 weeks of the intervention.
Adherence — measured over The 8 weeks of the intervention.
Acceptability of the randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → process — measured over Months prior to the intervention.
The study lists 3 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05997680 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Parent-child yogaBehavioural
The 45-minute yoga sessions are structured to include an opening and a closing ritual that remain the same throughout the 8 weeks, between which an active and a calming parts are scheduled. The active and calming parts are embedded in stories that align with the developmental level and interests typical of 4-to-6-year-olds. Each session is clearly structured with each exercise and transition well described in the Yoga for Little Hearts Yoga Program Manual. In addition to the yoga sessions, at-home exercises (5 min) including breathing, meditation and mindfulness activities will be explained to participants. We will ask them to practice them at home at least 3 times every week, for the 8-week duration of the intervention. Including the yoga session and home exercises, the 8-week intervention thus includes at least 60 minutes of yoga per week. Parents will be encouraged to pursue the at-home exercises after the end of the 8-week yoga program, up to the 6-month follow-up.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 4 years to 6 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 4 years to 6 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 2 months prior to the intervention..
The study as a whole is currently expected to finish around 2025-10-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 24 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The proposed study aims to determine the feasibility of the procedures for a future full randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga intervention in reducing attention deficits in children with congenital heart disease (CHD). Specific aims of this single-blind, two-arm, two-center feasibility trial are to evaluate recruitment rates and capacity, withdrawal and dropout rates, adherence to the intervention, acceptability of the randomization process by families, variation in delivery of the intervention between yoga instructors, and standard deviation of main outcomes of the future RCT in order to determine its appropriate sample size. This feasibility study will lead to the first ever RCT to test the efficacy of an intervention strategy for reducing attention deficits in children with CHD. Ultimately, the implementation of this parent-child yoga program will lead to better long-term academic and psychosocial functioning and quality of life for these children and their family.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.