[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656608":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":27,"studyPopulation":16,"armGroups":28,"interventions":37,"overallOfficials":16,"centralContacts":43,"locations":16,"responsibleParty":49,"collaborators":16,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":16,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":77,"whyStopped":16,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":16},{"fullName":5,"class":6},"Mansoura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Neonatal Pain","The Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).","through study completion, an average of 3 months",{"measure":14,"description":15,"timeFrame":12},"Behavioral State","The Brazelton Neonatal Behavioral Assessment Scale (NBAS) state categories will be used to classify the neonate's behavioral state",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":22,"maskingDescription":23,"whoMasked":24},"DOUBLE","* Research assistants performing pain score assessments will be blinded to group allocation (video assessments will be conducted by assessors unaware of group assignment).\n* Parents cannot be blinded due to the nature of the intervention.\n* Nurses performing the heel lance cannot be blinded due to the visibility of the intervention.\n* Data analysts will be blinded to group allocation",[25,26],"INVESTIGATOR","OUTCOMES_ASSESSOR","While pharmacological analgesia is available, its use in neonates is often limited by concerns regarding dosing complexity, potential adverse effects, and safety in this vulnerable population. Consequently, non-pharmacological strategies have become central to neonatal pain management. Interventions such as kangaroo care (skin-to-skin contact), facilitated tucking, breastfeeding, sweet solutions, non-nutritive sucking, and various forms of auditory and tactile stimulation have consistently demonstrated effectiveness in reducing both behavioral and physiological indicators of pain. Breastfeeding has also been identified as the most effective method to reduce pain during heel lance in term newborns. Moreover, auditory interventions such as white noise and mother-sung lullabies have been shown to significantly reduce neonatal pain scores. These findings underscore the growing evidence base supporting non-pharmacological approaches.\n\ngarnered attention as a simple, low-cost, and potentially effective tool for neonatal pain management. The crochet octopus is a soft, handmade toy with long, curled tendrils that neonates can grasp, providing tactile stimulation theorized to operate via the gate control theory of pain, whereby non-painful tactile input can close the \"gates\" to painful signals in the spinal cord. A seminal randomized controlled study by Çövener Özçelik et al. (2023), conducted with 100 term neonates, demonstrated that infants who touched a crochet octopus during heel lance had significantly higher oxygen saturation levels, shorter crying durations, and lower pain scores compared to the control group. More recently, Reddy et al. (2025) confirmed these findings in a randomized controlled trial involving 100 neonates, showing that octopus therapy significantly reduced pain scores, stabilized physiological parameters, and decreased crying duration during minor procedures. The intervention, where the octopus is provided 10 minutes before the procedure, has been shown to affect physiological measurements positively and reduce procedural pain.",[29,34],{"label":30,"type":31,"description":30,"interventionNames":32},"Intervention Group (Crochet Octopus)","EXPERIMENTAL",[33],"Device: Crochet Octopus",{"label":35,"type":36,"description":35,"interventionNames":16},"Control Group (Standard Care)","NO_INTERVENTION",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"DEVICE","Crochet Octopus","1. A standard crochet octopus will be placed with the neonate 10 minutes before the heel lance procedure.\n2. The octopus will be positioned so that the neonate can touch its tendrils.\n3. The octopus will remain with the neonate during the heel lance procedure.\n4. The octopus will remain with the neonate for 10 minutes after the procedure completion.\n5. Standard nursing care will be provided as per unit protocol.\n\nCrochet Octopus Specifications:\n\n* Handmade using 100% cotton yarn\n* Soft, with 8 curled tendrils approximately 15-20 cm in length\n* Hypoallergenic materials\n* Washable and sterilizable\n* Standard design consistent with published protocols",[30],[44],{"name":45,"role":46,"phone":47,"phoneExt":16,"email":48},"Sara Mustafa Hamza Taha, PhD","CONTACT","+20 01098022749","sarahamza@mans.edu.eg",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Sara Mustafa Hamza Taha","Lecture of Pediatric Nursing, Pediatric Nursing Department, Faculty of Nursing, Mansoura University","100656608","crochet-octopus-in-reducing-procedural-pain-during-heel-lance-in-preterm-neonates-100656608",false,"NCT07828795","Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates","Effect of a Crochet Octopus in Reducing Procedural Pain and Improving Physiological and Behavioral Responses During Heel Lance in Preterm Neonates: A Randomized Controlled Trial","RCT","Inclusion Criteria\n\n* Preterm neonates: Gestational age 32-37 weeks\n* Age: 2-30 days postnatal\n* Clinically stable\n* Requiring heel lance for routine blood sampling Exclusion Criteria\n* Major congenital anomalies\n* Neurological disorders\n* Received pharmacological analgesia within 24 hours prior to the procedure\n* Receiving mechanical ventilation or continuous positive airway pressure (CPAP)","ALL","2 Days","30 Days",{"count":65,"type":66},98,"ESTIMATED","INTERVENTIONAL",[69],"NA","Neonates, particularly those hospitalized in neonatal intensive care units (NICUs), are subjected to numerous painful procedures essential for their diagnosis and monitoring. Heel lance, performed for routine blood sampling, stands as one of the most frequently encountered painful experiences for these vulnerable infants, as robust neurobiological evidence confirms that even preterm infants possess the anatomical and functional capacity to perceive pain, manifesting measurable physiological, hormonal, and behavioral responses. The daily average of acute painful events can reach up to 10-15 procedures in the NICU, and repeated exposure to inadequately managed procedural pain has been associated with immediate physiological instability as well as longer-term alterations in stress regulation, somatosensory processing, and neurodevelopmental outcomes. These vulnerabilities are further compounded in preterm and low birth weight infants who require prolonged hospitalization and specialized care.",[72,73,74],"Preterm Neonates","Heel Lance Procedures","Procedural Pain",[40,74,76,72],"Heel Lance","NOT_YET_RECRUITING","2026-09-18",{"date":80,"type":81},"2026-09-23","ACTUAL",{"date":83,"type":66},"2026-10-01",{"date":85,"type":66},"2027-09-01",{"name":5,"class":6}]