[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636980":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":32,"responsibleParty":52,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Breathing exercises","EXPERIMENTAL","In addition to the standard care in the Pediatric Emergency Department, the intervention group will have a daily 10-minutes paced breathing home-exercise program. The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.",[13],"Behavioral: Paced breathing exercises",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Treatment for a concussion involves relative physical and cognitive rest for 24-48 hours, followed by gradually returning to normal activities and school as symptoms improve.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Paced breathing exercises","The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Isabelle Gagnon, PhD","CONTACT","514-412-4400","23896","isabelle.gagnon8@mcgill.ca",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Montreal Children's Hospital","RECRUITING","Montreal","Quebec","H4A 3J1","Canada","CA",{"type":42,"coordinates":43},"Point",[44,45],-73.58781,45.50884,{"lat":45,"lon":44},[48,49],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":50,"role":28,"phone":18,"phoneExt":18,"email":51},"Joanna Mazza","joanna.mazza@muhc.mcgill.ca",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Isabelle Gagnon","Clinical Scientist","100636980","impact-of-a-paced-breathing-exercise-intervention-on-autonomic-nervous-system-function-after-pediatric-concussion-acute-phase-100636980",false,"NCT07572734","Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)","Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study","Breathe - PED","Inclusion Criteria:\n\n* Aged 9-18 years old\n* 0-72 hours post-concussion\n* present to the ED with at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances)\n\nExclusion Criteria:\n\n* known heart disease,\n* previous neurological problems other than concussion","ALL","9 Years","18 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the acute period after concussion. Secondary objectives include documenting symptom severity (ANS related symptoms, post-concussion symptoms, anxiety, sleep) before and after administration of the intervention and examine whether early paced-breathing exercise can accelerate recovery and symptom improvement.\n\nParticipants will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment, information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.",[75],"Concussion, Mild Traumatic Brain Injury","2026-05-07",{"date":78,"type":79},"2026-05-12","ACTUAL",{"date":81,"type":79},"2026-05-01",{"date":83,"type":69},"2027-05-30",{"name":5,"class":6},1]