Maternal Sensory Interventions in Newborns (MSI)
24. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Edanur Tar Bolacali, PhD
- Telefonnummer: +908504412483
- E-post: edanurtar.1107@gmail.com
Studer Kontakt Backup
- Navn: Sibel Kucukoglu, PhD
- Telefonnummer: +903322231623
- E-post: s_nadaroglu@hotmail.com
Studiesteder
-
-
Kırşehir
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Kırşehir, Kırşehir, Tyrkia (Türkiye), 40100
- Kirsehir Ahi Evran Universty
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Ta kontakt med:
- Edanur Tar Bolacalı, PhD
- Telefonnummer: +908504412483
- E-post: edanurtar.1107@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Eksperimentell: 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.
|
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.
|
|
Eksperimentell: 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.
|
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.
|
|
Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sleep Onset Latency
Tidsramme: From the beginning of the intervention until sleep onset, assessed within 60 minutes
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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.
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From the beginning of the intervention until sleep onset, assessed within 60 minutes
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Sleep-Wake States Assessed by Bispectral Index
Tidsramme: During the 60-minute observation period following routine midday care and feeding
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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.
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During the 60-minute observation period following routine midday care and feeding
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Mean Bispectral Index Score
Tidsramme: During the 60-minute observation period
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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.
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During the 60-minute observation period
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Heart Rate
Tidsramme: Baseline, 15, 30, and 60 minutes after the intervention or routine care
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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.
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Baseline, 15, 30, and 60 minutes after the intervention or routine care
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Respiratory Rate
Tidsramme: Baseline, 15, 30, and 60 minutes after the intervention or routine care
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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.
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Baseline, 15, 30, and 60 minutes after the intervention or routine care
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Oxygen Saturation (SpO₂)
Tidsramme: Baseline, 15, 30, and 60 minutes after the intervention or routine care
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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.
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Baseline, 15, 30, and 60 minutes after the intervention or routine care
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
- Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
- Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.
- intensive care unit. Medicine, 100(43), e27587. https://doi.org/10.1097/md.0000000000027587 Kahraman, A., Başbakkal, Z., & Yalaz, M. (2014). Turkish validity and reliability of the Newborn Comfort Behavior Scale. International Refereed Journal of Nursing Research, 1(2), 1-11.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. august 2026
Primær fullføring (Antatt)
15. oktober 2026
Studiet fullført (Antatt)
30. desember 2026
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
21. juli 2026
Først lagt ut (Faktiske)
24. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KAEU-NICU-2026-01
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