Crochet Octopus Therapy as a Non-Pharmacological Pain Reducing Measure During Intra Venous Cannulation in Moderate Preterm and Late Preterm: A Randomised Controlled Trial

This randomized controlled trial aims to evaluate the effect of Crochet Octopus Therapy (COT) on pain response during IV cannulation in newborns. Eligible neonates admitted to the NICU will be enrolled after obtaining written informed consent from parents. Participants will be randomly allocated into two groups using a computer-generated randomization table, with allocation concealment ensured via the SNOSE (Sequentially Numbered, Opaque, Sealed Envelopes) method.In the intervention group, neonates will receive Kangaroo Mother Care (KMC) while holding a crochet octopus infused with the mother’s scent. The octopus will remain with the baby in the cradle after each KMC session. This therapy will be continued for at least 24 hours before IV cannulation.The control group will receive standard care without any additional comfort measures before IV cannulation. In both groups, IV cannulation will be performed on the dorsum of the hand using the same brand and size of standard IV cannula by the principal investigator to maintain uniformity.A video of the procedure will be recorded for pain assessment, beginning 30 seconds before and continuing for 30 seconds after the cannulation or until the baby stops crying. NICU environmental conditions will be maintained between 25–28°C with noise levels below 35–40 decibels. Behavioral state, heart rate, and oxygen saturation will be recorded 30 seconds before and after the procedure. Pain will be assessed using video-based scoring post-procedure.