MOTHER3SENSE Study

Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions

This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.

Painful procedures are frequently performed in newborns during routine clinical care and may lead to physiological and behavioral stress responses. Non-pharmacological interventions are recommended as safe and effective approaches for reducing procedural pain and stress in newborns. Maternal sensory stimuli, including maternal voice, touch, and scent, may provide comfort and support neonatal regulation during painful procedures.

This randomized controlled trial aims to compare the effects of maternal voice, maternal touch, and maternal scent on pain and stress responses in newborns undergoing a routine heel lance procedure. Eligible newborns will be randomly assigned to one of four groups: maternal voice, maternal touch, maternal scent, or control.

The assigned intervention will be applied according to a standardized protocol before, during, and after the heel lance procedure. Pain and stress responses will be assessed at three time points: before the procedure, during the procedure, and after the procedure. Behavioral and physiological indicators will be used to evaluate neonatal pain and stress responses.

The primary objective of the study is to determine and compare the effectiveness of maternal voice, touch, and scent in reducing procedural pain and stress in newborns. The findings may contribute to evidence-based, family-centered, and non-pharmacological pain management practices in neonatal care.

Inclusion Criteria:

• Term newborns born between 37 and 42 weeks of gestation
• Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases
• Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment
• Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)
• Mothers willing to participate in the study
• Written informed consent provided by the parent or legal guardian
• Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)

Exclusion Criteria:

• Preterm (<37 weeks) or post-term (>42 weeks) newborns
• Presence of congenital anomalies or neurological disorders
• Requirement for oxygen therapy, phototherapy, or intravenous treatment
• Respiratory, cardiac, metabolic, neurological, or infectious disease
• Abnormal vital signs before the procedure
• Parent or legal guardian refusal to provide informed consent