[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653552":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":40,"overallOfficials":13,"centralContacts":50,"locations":13,"responsibleParty":56,"collaborators":13,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":13,"maxAge":13,"enrollmentInfo":69,"targetDuration":13,"studyType":72,"phases":73,"briefSummary":23,"conditions":75,"keywords":77,"overallStatus":78,"whyStopped":13,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":13},{"fullName":5,"class":6},"RAK Medical and Health Sciences University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Pain Intensity During Phlebotomy (Neonatal Infant Pain Scale [NIPS])","Pain intensity will be assessed using the Neonatal Infant Pain Scale (NIPS), a behavioral and physiological pain assessment tool with a total score ranging from 0 to 7, with higher scores indicating greater pain. The mean change from baseline will be compared among the Yakson Touch, Dextrose-Sweetened Pacifier, and Routine Care groups.","Baseline (5 minutes immediately prior to venipuncture), intra-procedure (during the blood draw), and post-procedure (1 minute and 5 minutes after needle withdrawal).",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NON_RANDOMIZED","FACTORIAL","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","INVESTIGATOR","To compare the effects of Yakson Touch, the Dextrose-Sweetened Pacifier, and routine care on physiological responses, pain intensity, and behavioral outcomes among term neonates undergoing phlebotomy.",[25,31,36],{"label":26,"type":27,"description":28,"interventionNames":29},"Yakson Touch Group","EXPERIMENTAL","Participants receive Yakson Touch during the phlebotomy procedure as a non-pharmacological pain management intervention. Yakson Touch is administered during the painful procedure, and physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) are assessed before, during, and after phlebotomy.",[30],"Behavioral: Yakson Touch",{"label":32,"type":27,"description":33,"interventionNames":34},"Dextrose-Sweetened Pacifier Group","Participants receive a dextrose-sweetened pacifier during the phlebotomy procedure as a non-pharmacological pain management intervention. Physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) are assessed before, during, and after phlebotomy.",[35],"Behavioral: Dextrose-Sweetened Pacifier",{"label":37,"type":38,"description":39,"interventionNames":13},"Routine Care Group","NO_INTERVENTION","Participants receive routine NICU care during the phlebotomy procedure without Yakson Touch or a dextrose-sweetened pacifier. Physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) are assessed before, during, and after phlebotomy.",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"BEHAVIORAL","Yakson Touch","Yakson Touch is a non-pharmacological tactile intervention administered to term neonates during phlebotomy to reduce procedural pain and behavioral distress. The intervention is provided during the phlebotomy procedure, with physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) assessed before, during, and after the procedure.",[26],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":13},"Dextrose-Sweetened Pacifier","A dextrose-sweetened pacifier is provided to term neonates during phlebotomy as a non-pharmacological intervention for procedural pain management. Physiological parameters, pain intensity using the Premature Infant Pain Profile (PIPP), and behavioral responses using the Anderson Behavioral State Scale (ABSS) are assessed before, during, and after the phlebotomy procedure.",[32],[51],{"name":52,"role":53,"phone":54,"phoneExt":13,"email":55},"mona gamal","CONTACT","+971514146521","mona.mohamed2100@yahoo.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mona Gamal","Associate Professor","100653552","comparative-effectiveness-of-yakson-touch-and-a-dextrose-sweetened-pacifier-for-reducing-phlebotomy-induced-pain-in-term-neonates-100653552",false,"NCT07788066","Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates","Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates: A Three-Arm Randomized Controlled Trial","Yakson Touch;","Inclusion Criteria:\n\nTerm neonates admitted to the NICU. Neonates undergoing clinically indicated phlebotomy. Neonates whose parent or legally authorized representative provides informed consent for participation.\n\nExclusion Criteria:\n\nNeonates with conditions that may significantly affect pain assessment or physiological responses during phlebotomy.\n\nNeonates receiving analgesic or sedative medications that could influence pain or behavioral responses.\n\nNeonates with contraindications to the study interventions. Neonates whose parent or legally authorized representative does not provide consent.","ALL",{"count":70,"type":71},2,"ESTIMATED","INTERVENTIONAL",[74],"NA",[76],"Hospital Acquired Infections",[47],"NOT_YET_RECRUITING","2026-08-23",{"date":81,"type":82},"2026-08-26","ACTUAL",{"date":84,"type":71},"2026-08-01",{"date":86,"type":71},"2026-12-11",{"name":5,"class":6}]