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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Maternal Voice
Other interventionThe recorded maternal voice will be presented to the newborn before, during, and after the procedure.
Maternal Touch
Other interventionThe 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
Other interventionThe newborn will be exposed to maternal breast milk scent during the procedure.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Maternal VoiceExperimental treatment 1 intervention
Group B: Maternal TouchExperimental treatment 1 intervention
Group C: Maternal ScentExperimental treatment 1 intervention
Group D: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neonatal Infant Pain Scale
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.
Time frame
Before the procedure, during the procedure, and immediately after the procedureSecondary outcomes
1
Newborn stress scale
The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.
Time frame
Before the procedure, during the procedure, and immediately after the procedureOther outcomes
1
Newborn and Maternal Characteristics Form
This researcher-developed form, based on the literature, was used to systematically collect demographic information about mothers and medical and birth-related characteristics of newborns.
Time frame
At baseline2
Neonatal Physiological Parameters Monitoring Form
The Newborn Physiological Parameters Assessment Form was developed by the researchers based on the literature and was used to evaluate physiological parameters, including heart rate, oxygen saturation, and body temperature, before, during, and after the heel lance procedure.
Time frame
Before the procedure, during the procedure, and immediately after the procedureSponsors and contacts
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Source ClinicalTrials.gov
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