About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm neonates: Gestational age 32-37 weeks
Age: 2-30 days postnatal
Clinically stable
Requiring heel lance for routine blood sampling
Disqualifiers
Major congenital anomalies
Neurological disorders
Received pharmacological analgesia within 24 hours prior to the procedure
Receiving mechanical ventilation or continuous positive airway pressure (CPAP)
Trial design
Parallel
Treatments tested in this trial
Crochet Octopus
Device1. A standard crochet octopus will be placed with the neonate 10 minutes before the heel lance procedure. 2. The octopus will be positioned so that the neonate can touch its tendrils. 3. The octopus will remain with the neonate during the heel lance procedure. 4. The octopus will remain with the neonate for 10 minutes after the procedure completion. 5. Standard nursing care will be provided as per unit protocol. Crochet Octopus Specifications: * Handmade using 100% cotton yarn * Soft, with 8 curled tendrils approximately 15-20 cm in length * Hypoallergenic materials * Washable and sterilizable * Standard design consistent with published protocols
Treatment groups
Trial outcomes
Primary outcomes
Neonatal Pain
The Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).
Behavioral State
The Brazelton Neonatal Behavioral Assessment Scale (NBAS) state categories will be used to classify the neonate's behavioral state
Locations
Sponsors and contacts
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