A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
A legfontosabb adatok
- Ki végzi
- Anne Gallagher
- Hol
- Montreal (Kanada)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 24 fő, tervezett
- Kezdés
- 2023. okt. 1.
- Tervezett befejezés
- 2025. okt. 1.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Parent-child yoga
- A regiszteradat frissítve
- 2024. november 29.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for children aged 4 to 6 with congenital heart disease (a heart problem present from birth) who needed heart surgery and have attention problems. A parent joins an 8-week parent-child yoga program with the child.
- Életkor
- 4 to 6 years
- Nem
- All
- A betegség stádiuma
- Congenital heart disease that needed heart surgery.
- Korábbi kezelés
- Children cannot join if they did a structured weekly yoga program for at least a month in the past year. Children taking ADHD medication can join if the parent agrees to stop it at least 48h before each assessment.
- Biomarker vagy leletérték
- Poor attention on the K-CPT2 test: Variability score 0.5 standard deviation below norms.
A részvétel fő kizáró okai
- A medical reason not to practise yoga
- Confirmed severe developmental or intellectual delay that would prevent finishing the study tests
- Severe physical handicap that stops the child doing yoga without special changes
- Family does not speak French or English
- A parent not willing to take part in the yoga program and the follow-up assessments
A regiszter feltételei, szó szerint
Mind a 13 feltétel megnézéseKevesebb
Ki nem vehet részt
- 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; Eligibility 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
Egyéb feltételek
- To be eligible for the study, children need to meet the following inclusion criteria:
- diagnosis of CHD requiring heart surgery
- 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 criteria 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-up 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 4 és 6 év között vagy?
Helyszínek itt: Kanada
- Centre Hospitalier Universitaire Sainte-JustineMontreal, KanadaContact: Anne Gallagher, PhDRésztvevőt keres
- Centre universtaire de santé McGillMontreal, KanadaContact: Marie Brossard-Racine, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Yoga groupA vizsgált kezelés
Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.
Kezelés: Parent-child yoga
- Waitlist control groupNincs vizsgálati kezelés, összehasonlításként
Participants with CHD undergoing neurodevelopmental assessments at the same time as the yoga group participants and benefiting from standard of care only during the 8 weeks of the intervention. The yoga intervention will be made available to all waitlist control group participants once their trial wave is completed.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT05997680: ki vehet részt
- A regiszteradat frissítve
- 2024. november 29.