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
| Registry | NCT07828795, acronym RCT |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 98 (Estimated) |
| Sponsor | Mansoura University (Other) |
| Conditions | Preterm Neonates, Heel Lance Procedures, Procedural Pain |
| Interventions | Crochet Octopus (Device) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-09-18, last updated 2026-09-23 |
Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Neonates All trials for Heel Lance Procedures All trials of Crochet Octopus
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group (Crochet Octopus) | Experimental | Device: Crochet Octopus | Intervention Group (Crochet Octopus) |
| Control Group (Standard Care) | No intervention | Control Group (Standard Care) |
Sex: All, ages: 2 Days to 30 Days
Inclusion Criteria * Preterm neonates: Gestational age 32-37 weeks * Age: 2-30 days postnatal * Clinically stable * Requiring heel lance for routine blood sampling Exclusion Criteria * Major congenital anomalies * Neurological disorders * Received pharmacological analgesia within 24 hours prior to the procedure * Receiving mechanical ventilation or continuous positive airway pressure (CPAP)