[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612074":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":80,"whyStopped":12,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual practice","NO_INTERVENTION","In this arm, venipuncture will be performed according to usual care. The usual care recommended for young children is as follows:\n\n* The child is lying down, sitting or in a semi-setting position or in the arms of an adult (parent or health professional).\n* Parents are present if they wish. The child may have his or her cuddly toy.\n* Analgesia is administered using anaesthetic cream and, depending on the child and the department's routine, anaesthetic cream and\u002For nitroxusmay be added.\n* No distracting objects are used apart from the voice (whispers, unsung words) or reassuring gestures as in usual practice (e. g. caresses, gentle rocking ). No active distraction with a toy or a screen are offered.\n* The child's gestures may be restrained by the professional(s) if necessary, in accordance with the department's policies and current practices. 62 caractères maximum.\n\nFacultatif si la description de l'intervention (cf. ci-dessous) décrit suffisamment le bras.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Usual practice and active distraction.","EXPERIMENTAL","Venipuncture will be performed according to the usual care with the addition of active distraction using the maraca.\n\nActive distraction procedure: The nurse performing the venipuncture called the operator and a professional called the 'accompanying person' (nurse, nursing assistant or childcare assistant usually in charge of looking after or holding the child) sit on either side of the child.\n\n* At the start of the procedure, the accompanying person places the maraca in the child's hand and shows him\u002Fher that it makes a noise 30 seconds before the venipuncture. The accompanying person checks the movement of the child's hand by placing his\u002Fher own hand on the child's hand. He\u002Fshe playfully suggests to the child to wait to make noise with the maraca by counting down 'on 3, we'll make noise'. This countdown allows coordination with the operator.\n* When the operator is ready to perform the venipuncture, the accompanying person invites the child to gently shake the maraca.\n\nIf the venipun",[18],"Other: Guided movement",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Guided movement","Active distraction procedure:\n\nVenipuncture will be performed according to the usual care with the addition of active distraction using the maraca.\n\nActive distraction procedure: The nurse performing the venipuncture called the operator and a professional called the 'accompanying person' (nurse, nursing assistant or childcare assistant usually in charge of looking after or holding the child) sit on either side of the child.\n\n* At the start of the procedure, the accompanying person places the maraca in the child's hand and shows him\u002Fher that it makes a noise 30 seconds before the venipuncture. The accompanying person checks the movement of the child's hand by placing his\u002Fher own hand on the child's hand. He\u002Fshe playfully suggests to the child to wait to make noise with the maraca by counting down 'on 3, we'll make noise'. This countdown allows coordination with the operator.\n* When the operator is ready to perform the venipuncture, the accompanying person invites the child to gently sha",[14],[25],{"name":26,"affiliation":5,"role":27},"Bénédicte LOMBART, Paramedical coordinator","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","0033171970607","benedicte.lombart@aphp.fr",{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},"Judith LEBLANC, Associate professor","0033171970555","judith.leblanc@aphp.fr",[38],{"facility":39,"status":12,"city":40,"state":12,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Direction de la recherche et de l'innovation","Paris","75012","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.3488,48.85341,{"lat":48,"lon":47},[51,52],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},{"type":54,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100612074","guided-distraction-movement-100612074",false,"NCT07248852","Guided Distraction Movement","Benefits of Guided Movement Using a Maraca of the Arm Opposite to the One Undergoing Venipuncture to Reduce Pain in Children Aged 1-3 Years: a Multicentre Randomized Controlled Trial","MOVING","Inclusion Criteria:\n\n* aged 1 to 3 years\n* with a venipuncture prescribed within the first 48 hours of hospitalization in general paediatrics or during a consultation\n\nExclusion Criteria:\n\n* motor disability of upper limbs\n* mental disability with neuromotor troubles\n* venipuncture or other invasive procedure (lumbar puncture or catheter insertion) within 2 hours prior to inclusion\n* more than 5 venipunctures within 48 hours prior to inclusion\n* clinical condition requiring emergency venous access","ALL","1 Year","3 Years",{"count":67,"type":68},160,"ESTIMATED","INTERVENTIONAL",[71],"NA","The aim of this research is to evaluate the benefits of using a maraca to guide movement in order to reduce pain during venipuncture for blood sampling or infusion (insertion of a peripheral venous line) in children aged 1 to 3 years.\n\nPharmacological methods can reduce the pain associated with venipuncture, but they do not address all aspects of pain. Complementary methods have been studied, such as distraction.\n\nAccording to the literature, interventions in which the child actively participates, with motor action, have been little explored before 3 years of age.\n\nEncouraging children aged 1 to 3 years to perform a movement using a maraca of the arm opposite to the one undergoing venipuncture, in synchronisation with the venipuncture, in addition to current pharmacological methods, would be a simple active intervention.\n\nThis distraction method has never been studied. It could reduce pain, withdrawal reactions and also the need for restraint by caregivers, leading to better acceptance of treatment and a higher success rate.\n\nDuring a multicentre randomized controlled trial conducted in France, the benefits of guided movement using a maraca of the arm opposite to the one undergoing venipuncture synchronised with venipuncture and combined with the usual practice, will be compared with the usual practice alone. 5000 caractères maximum",[74],"Venipuncture Pain",[76,77,78,79],"Active distraction","Venipuncture","Children","Pain","NOT_YET_RECRUITING","2026-02-06",{"date":83,"type":84},"2026-02-10","ACTUAL",{"date":86,"type":68},"2026-02",{"date":88,"type":68},"2027-02",{"name":5,"class":6},1]