[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564054":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":82,"collaborators":28,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":28,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":28,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":59,"whyStopped":28,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Massachusetts, Worcester","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"ShotBlocker Administration","EXPERIMENTAL","The treatment group will employ the medical device of interest, ShotBlocker, bundled with the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.",[13,14,15,16],"Device: Bionix ShotBlocker","Other: Swaddling","Other: Sucrose administration","Other: Masimo Rad-97 Oximeter probe",{"label":18,"type":19,"description":20,"interventionNames":21},"Standard of Care Comfort Tools","ACTIVE_COMPARATOR","The control group will employ the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.",[14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Bionix ShotBlocker","This is a hospital-approved device used as standard-of-care in older children and adults to reduce pain during painful procedures. It is not considered established standard-of-care in the infant cohort.",[9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Swaddling","Standard of care swaddling",[9,18],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Sucrose administration","Standard of care sucrose administration",[9,18],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Masimo Rad-97 Oximeter probe","Oximeter probe",[9,18],[42],{"name":43,"affiliation":44,"role":45},"Lauren Fortier, CPNP, MSN","Pediatric Nurse Practitioner for the Department of Pediatrics & PICU","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Madeline French, BS MBE","CONTACT","5088870106","madeline.french2@umassmed.edu",{"name":53,"role":49,"phone":54,"phoneExt":28,"email":55},"Samia Binta Rahman, MBBS MPH","6034179792","samiabinta.rahman6@umassmed.edu",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"UMass Memorial Medical Center- Memorial Campus","RECRUITING","Worcester","Massachusetts","01605","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-71.80229,42.26259,{"lat":69,"lon":68},[72,74,75,77,79],{"name":73,"role":49,"phone":50,"phoneExt":28,"email":51},"Madeline E French, BS MBE",{"name":53,"role":49,"phone":54,"phoneExt":28,"email":55},{"name":76,"role":45,"phone":28,"phoneExt":28,"email":28},"Lauren Fortier, CPNP MSN",{"name":78,"role":45,"phone":28,"phoneExt":28,"email":28},"Lawrence Rhein, MD MPH",{"name":80,"role":81,"phone":28,"phoneExt":28,"email":28},"Mark Vining, MD","SUB_INVESTIGATOR",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Lauren Fortier","Instructor","100564054","shotblocker-during-intramuscular-injection-randomized-control-trial-100564054",false,"NCT06624176","ShotBlocker During Intramuscular Injection Randomized Control Trial","The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team\n* Term infants (37 to 42 weeks gestational age)\n* No acute illness that causes pain\n* Apgar score above 7 at 5 minutes\n* Have successfully attempted at least one oral feeding\n* No circumcision in the last 6 hours\n* Parental consent for Hepatitis B vaccine\n\nExclusion Criteria:\n\n* Swallow dysfunction\n* Congenital or genetic abnormalities\n* Infants who were exposed to sedatives within the last 12 hours\n* Infants with skin on thigh, hand, or foot that is not intact\n* Diagnosis of Neonatal Abstinence Syndrome (NAS)\n* Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)\n* Department of Children and Families (DCF) custody",true,"ALL","37 Weeks","42 Weeks",{"count":98,"type":99},200,"ESTIMATED","INTERVENTIONAL",[102],"NA","The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.",[105],"Neonatal Pain",[107,105,108],"ShotBlocker","Needlestick","2026-06-02",{"date":111,"type":112},"2026-06-04","ACTUAL",{"date":114,"type":112},"2024-01-10",{"date":116,"type":99},"2026-10-01",{"name":84,"class":6},1]