An interventional study of Crochet Octopus in Preterm Neonates, Heel Lance Procedures and Procedural Pain, sponsored by Mansoura University. Not yet recruiting. Open to participants aged 2 Days to 30 Days. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
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.
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.
garnered 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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 98 is close to the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Intervention Group (Crochet Octopus)
Device: Crochet Octopus
Control Group (Standard Care)
1. 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
Neonatal Pain
The Premature Infant Pain Profile (PIPP) will be used to assess pain in preterm neonates (gestational age 32-36 weeks).
Time frame: through study completion, an average of 3 months
Behavioral State
The Brazelton Neonatal Behavioral Assessment Scale (NBAS) state categories will be used to classify the neonate's behavioral state
Time frame: through study completion, an average of 3 months
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared publicly because the dataset contains potentially identifiable participant information. Sharing the raw data could compromise participants' privacy and confidentiality. Therefore, IPD will not be made publicly available. However, anonymized or aggregated data may be considered for sharing upon reasonable request, subject to ethical approval, institutional policies, and applicable data-protection regulations.
Start is estimated for Oct 2026; primary completion for Feb 2027, 4 months later.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 4 months is below that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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