Effectiveness of white noise for reducing invasive procedural pain in neonates: A co-designed randomized controlled trial protocol

Objective: To develop a white-noise intervention protocol through a co-design approach and evaluate the effectiveness of white noise in reducing pain associated with invasive procedures in term neonates. Methods: This study comprises two phases. Phase 1 will use a co-design approach involving researchers, physicians, nurses, and parents/legal guardians to refine the intervention protocol. Phase 2 will be a two-arm, parallel-group randomized controlled trial conducted in the Neonatal Unit of Phenikaa University Hospital. A total of 70 term neonates scheduled to undergo invasive procedures will be recruited. Participants will be randomly allocated in a 1:1 ratio to either the white-noise group or the usual-care group. Conclusion: This standardized protocol may provide a basis for evaluating and integrating white noise into non-pharmacological pain management for neonates.