Multimodal non-pharmacological pain relief during adhesive tape removal in preterm infants: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of facilitated tucking combined with oral breast milk (FT + OBM) and kangaroo care combined with oral breast milk (KC + OBM) in reducing pain during adhesive tape removal in preterm infants. STUDY DESIGN: This randomized controlled trial was conducted in a Level III NICU in Turkey and registered with the clinical trial ID NCT06455631. A total of 119 preterm infants (gestational age 30⁰⁄⁷-36⁶⁄⁷ weeks) were randomly assigned to FT + OBM, KC + OBM, or control groups. Pain was assessed using the Premature Infant Pain Profile-Revised, and physiological parameters were analyzed using generalized estimating equations. RESULTS: Both intervention groups showed significantly lower pain scores than the control group (p < 0.001). Pain increased during tape removal but decreased afterward in both intervention groups. No significant difference was found between intervention groups. CONCLUSION: Two intervention groups are effective non-pharmacological strategies for reducing pain in preterm infants. CLINICAL TRIAL REGISTRATION: The trial has been registered on www. CLINICALTRIALS: gov , ID: NCT06455631. Patient enrollment began prior to trial registration due to the urgency of recruiting within a limited study period and delays in obtaining access to the trial registration platform. The study protocol was finalized and approved by the institutional ethics committee before enrollment, and no changes were made to the protocol after registration.