MOTHER3SENSE Study (MOTHER3SENSE)
11 juni 2026 bijgewerkt door: Elif Simay KOÇ, Kilis 7 Aralik University
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Elif Simay KOÇ, Lecturer
- Telefoonnummer: +90 348 813 93 01
- E-mail: kocelifsimay@gmail.com
Studie Locaties
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Kilis, Turkije (Türkiye), 79000
- Kilis Alaeddin Yavaşça State Hospital
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Contact:
- Elif Simay KOÇ
- Telefoonnummer: +90 348 813 93 01
- E-mail: kocelifsimay@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Maternal Voice
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
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The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
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Experimenteel: 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.
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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.
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Experimenteel: Maternal Scent
The newborn will be exposed to maternal breast milk scent during the procedure.
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The newborn will be exposed to maternal breast milk scent during the procedure.
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Geen tussenkomst: Control
Routine heel lance procedures will be performed, and no sensory intervention will be provided.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Neonatal Infant Pain Scale
Tijdsspanne: Before the procedure, during the procedure, and immediately after the procedure
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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.
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Before the procedure, during the procedure, and immediately after the procedure
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Newborn stress scale
Tijdsspanne: Before the procedure, during the procedure, and immediately after the procedure
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The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.
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Before the procedure, during the procedure, and immediately after the procedure
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Newborn and Maternal Characteristics Form
Tijdsspanne: At baseline
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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.
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At baseline
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Neonatal Physiological Parameters Monitoring Form
Tijdsspanne: Before the procedure, during the procedure, and immediately after the procedure
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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.
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Before the procedure, during the procedure, and immediately after the procedure
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
30 augustus 2026
Studie voltooiing (Geschat)
30 oktober 2026
Studieregistratiedata
Eerst ingediend
11 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 juni 2026
Eerst geplaatst (Werkelijk)
16 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
11 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Kilis 7 Aralık Universty
- MOTHER3SENSE Study (Andere identificatie: Kilis 7 Aralık Universty)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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