MOTHER3SENSE Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorKilis 7 Aralik University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Maternal Voice
- Maternal Touch
- Maternal Scent
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov