Efficacy and Safety of Occupational Therapy-Based Non-Pharmacological Interventions Combined with Heel Warming for Reducing Pain during Heel Lance in Preterm Neonates

Preterm neonates admitted to neonatal intensive care units (NICUs) are frequently exposed to painful procedures, with heel lance being one of the most commonly performed. Evidence shows that repeated unmanaged procedural pain in preterm infants is associated with altered pain sensitivity, physiological instability, and adverse neurodevelopmental outcomes. International guidelines, including those from the American Academy of Pediatrics and the World Health Organization, recommend the routine use of non-pharmacological interventions for procedural pain management in neonates.

Non-pharmacological strategies such as swaddling and non-nutritive sucking (NNS) have demonstrated efficacy in reducing behavioral and physiological pain responses during heel lance. Heel warming prior to capillary blood sampling has been shown to increase local blood flow, improve ease of sampling, and reduce procedural stress, while remaining safe when applied within recommended temperature limits. However, evidence on combined protocols integrating heel warming with structured developmental care interventions, particularly from an occupational therapy perspective, remains limited.

This prospective, multi-arm randomized controlled trial aims to evaluate the safety and efficacy of occupational therapy-based non-pharmacological interventions combined with heel warming in reducing pain during heel lance in preterm neonates (gestational age 30–36 weeks).

The study will be conducted in two phases: Phase 1, a pilot study assessing feasibility and safety; and Phase 2, a single-blind randomised controlled trial comparing four intervention groups: (1) swaddling with heel warming, (2) non-nutritive sucking with heel warming, (3) swaddling alone, and (4) non-nutritive sucking alone. Heel warming will be applied using a controlled commercial warming device at 38–40 °C for 3–5 minutes before heel lance.

Pain will be assessed using the Premature Infant Pain Profile-Revised (PIPP-R), a validated neonatal pain assessment tool. Physiological parameters (heart rate and oxygen saturation) and heel skin integrity will be monitored using the Neonatal Skin Condition Score (NSCS). Outcome assessors will be blinded to group allocation.

The findings of this study are expected to provide evidence for a safe, low-cost, and developmentally supportive pain-management protocol, strengthening the role of occupational therapy in neonatal procedural pain management in NICU settings