MOTHER3SENSE Study (MOTHER3SENSE)
Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Elif Simay KOÇ, Lecturer
- Telefonnummer: +90 348 813 93 01
- E-post: kocelifsimay@gmail.com
Studiesteder
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Kilis, Tyrkia (Türkiye), 79000
- Kilis Alaeddin Yavaşça State Hospital
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Ta kontakt med:
- Elif Simay KOÇ
- Telefonnummer: +90 348 813 93 01
- E-post: kocelifsimay@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Ingen inngripen: Control
Routine heel lance procedures will be performed, and no sensory intervention will be provided.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Neonatal Infant Pain Scale
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Newborn stress scale
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Newborn and Maternal Characteristics Form
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Kilis 7 Aralık Universty
- MOTHER3SENSE Study (Annen identifikator: Kilis 7 Aralık Universty)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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