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Maternal Sensory Interventions in Newborns (MSI)

24 juli 2026 bijgewerkt door: Edanur Tar Bolacali, Kirsehir Ahi Evran Universitesi

The Effect of Maternal Sensory Stimulation (Kangaroo Care, Lullabies, Tactile-Auditory Soothing) on Newborns' Sleep-Wake State and Physiological Parameters: A Randomized Controlled Trial

This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Sleep organization and physiological stability are essential indicators of neurological development and overall health in newborns. However, newborns hospitalized in neonatal intensive care units (NICUs) are frequently exposed to environmental stressors, including excessive noise, continuous lighting, routine caregiving activities, and medical procedures, which may adversely affect sleep quality and physiological stability. Maternal sensory interventions are non-pharmacological developmental care approaches that may promote relaxation, improve sleep organization, and support physiological regulation through tactile and auditory stimulation. This study is designed as a single-center, four-arm, parallel-group randomized controlled trial to evaluate the effects of maternal sensory interventions on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the NICU. Eligible clinically stable newborns will be randomly assigned in a 1:1:1:1 ratio to one of four groups: kangaroo care, maternal lullaby, maternal tactile-auditory soothing, or routine care (control). Following routine midday care and feeding, newborns in the kangaroo care group will receive uninterrupted skin-to-skin contact with their mothers for 60 minutes. In the maternal lullaby group, mothers will sing a lullaby of their choice for 15 minutes. In the maternal tactile-auditory soothing group, mothers will gently provide rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes. Infants in the control group will receive routine NICU care without additional intervention. All newborns will be monitored for a total of 60 minutes following the intervention or routine care. Sleep-wake states will be continuously assessed using the Bispectral Index (BIS) monitor. Physiological parameters, including heart rate, respiratory rate, and oxygen saturation, will be recorded at predetermined time points using standard patient monitoring equipment. Sleep onset latency, as well as the duration of wakefulness, REM sleep, light sleep, and deep sleep, will be calculated from BIS recordings. The findings of this study are expected to provide evidence regarding the effectiveness of maternal sensory interventions in improving sleep organization and physiological stability in newborns and to contribute to the development of evidence-based developmental care practices in neonatal intensive care units.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

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

Studie Contact Back-up

Studie Locaties

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:

  • Gestational age between 35 and 42 completed weeks.
  • Birth weight between 2,000 and 4,200 grams.
  • Clinically stable newborn admitted to the neonatal intensive care unit.
  • Spontaneous breathing without the need for mechanical ventilation.
  • Not receiving sedative medications.
  • Written informed consent obtained from a parent or legal guardian.

Exclusion Criteria:

  • Five-minute Apgar score <4.
  • Requirement for advanced resuscitation after birth.
  • Presence of a major congenital anomaly.
  • Requirement for invasive intervention involving the head region.
  • Diagnosed central nervous system dysfunction or neurological disorder.
  • Presence of severe postnatal medical complications that may affect study outcomes.

Exclusion Criteria (during the research):

  • The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes.
  • A parent or legal guardian withdraws consent for the newborn's participation in the study.

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: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention Group 1: Kangaroo Care
Participants assigned to this group will receive kangaroo care provided by their mothers for 60 minutes following routine midday care and feeding. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
Gedragsmatig: Kangaroo Care
Kangaroo care will be provided by the mother for 60 minutes following routine midday care and feeding. The newborn, wearing only a diaper, will be placed in an upright skin-to-skin position on the mother's bare chest. The infant's head will be positioned to maintain airway patency, and a light blanket will be used to maintain thermal stability. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored throughout the 60-minute observation period.
Experimenteel: Intervention Group 2: Maternal Lullaby
Participants assigned to this group will receive maternal lullaby intervention for 15 minutes following routine midday care and feeding. Mothers will sing a lullaby of their choice while the infant remains in the crib. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
Gedragsmatig: Maternal Lullaby
Following routine midday care and feeding, mothers will sing a lullaby of their choice to their newborn for 15 minutes while the infant remains in the crib. The lullaby will be performed in a soft, soothing voice at a sound level not exceeding 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
Experimenteel: Intervention Group 3: Maternal Tactile-Auditory Soothing
Participants assigned to this group will receive maternal tactile-auditory soothing for 15 minutes following routine midday care and feeding. Mothers will provide gentle rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış"). Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
Gedragsmatig: Maternal Tactile-Auditory Soothing
Following routine midday care and feeding, mothers will provide gentle rhythmic tactile stimulation by softly stroking the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds ("pış pış") for 15 minutes. The sound level will not exceed 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.
Geen tussenkomst: Routine Care (Control)
Participants assigned to this group will receive routine neonatal intensive care without any additional sensory intervention. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes following routine care.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sleep Onset Latency
Tijdsspanne: From the beginning of the intervention until sleep onset, assessed within 60 minutes
Sleep onset latency will be defined as the time, in minutes, from the beginning of the assigned intervention or routine care until the BIS value first decreases below 91, indicating transition from wakefulness to sleep.
From the beginning of the intervention until sleep onset, assessed within 60 minutes
Sleep-Wake States Assessed by Bispectral Index
Tijdsspanne: During the 60-minute observation period following routine midday care and feeding
Sleep-wake states will be assessed continuously using the Bispectral Index (BIS), a processed electroencephalographic monitoring system with scores ranging from 0 to 100, where higher scores indicate greater wakefulness and lower scores indicate deeper levels of sleep. BIS values will be classified as wakefulness (91-100), REM sleep (80-90), light sleep (55-79), and deep sleep (0-54). The duration and percentage of time spent in each sleep-wake state will be calculated during the 60-minute observation period.
During the 60-minute observation period following routine midday care and feeding
Mean Bispectral Index Score
Tijdsspanne: During the 60-minute observation period
The mean Bispectral Index (BIS) score will be calculated from values recorded at one-minute intervals throughout the 60-minute monitoring period. BIS scores range from 0 to 100, with higher scores indicating greater wakefulness and lower scores indicating deeper sleep.
During the 60-minute observation period

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart Rate
Tijdsspanne: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Heart rate (beats per minute) will be recorded using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
Baseline, 15, 30, and 60 minutes after the intervention or routine care
Respiratory Rate
Tijdsspanne: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Respiratory rate (breaths per minute) will be recorded using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
Baseline, 15, 30, and 60 minutes after the intervention or routine care
Oxygen Saturation (SpO₂)
Tijdsspanne: Baseline, 15, 30, and 60 minutes after the intervention or routine care
Peripheral oxygen saturation (SpO₂, %) will be measured using the standard patient monitor at baseline (0 minutes) and at 15, 30, and 60 minutes during the observation period.
Baseline, 15, 30, and 60 minutes after the intervention or routine care

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kirsehir Ahi Evran Universitesi

Publicaties en nuttige links

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Algemene publicaties

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)

15 augustus 2026

Primaire voltooiing (Geschat)

15 oktober 2026

Studie voltooiing (Geschat)

30 december 2026

Studieregistratiedata

Eerst ingediend

21 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2026

Eerst geplaatst (Werkelijk)

24 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KAEU-NICU-2026-01

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

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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