Maternal Voice: The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
Maternal Touch: The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
Maternal Scent: The newborn will be exposed to maternal breast milk scent during the procedure.
Study summary
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.
Eligibility
Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Neonatal Infant Pain Scale — Before the procedure, during the procedure, and immediately after the procedure The Neonatal Infant Pain Scale (NIPS), originally developed by Lawrence et al. (1993), was adapted into Turkish by Akdovan (Akdovan \& Yıldırım, 1999). NIPS is used to assess procedure-related pain in newborn infants. The scale evaluates five behavioral indicators-facial expression, crying, arm movements, leg movements, and state of arousal-as well as one physiological parameter, breathing pattern. Pain is assessed based on the evaluation of these behavioral and physiological responses.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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