Maternal Sensory Interventions in Newborns (MSI)
24 juli 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Edanur Tar Bolacali, PhD
- Telefonnummer: +908504412483
- E-post: edanurtar.1107@gmail.com
Studera Kontakt Backup
- Namn: Sibel Kucukoglu, PhD
- Telefonnummer: +903322231623
- E-post: s_nadaroglu@hotmail.com
Studieorter
-
-
Kırşehir
-
Kırşehir, Kırşehir, Turkiet (Türkiye), 40100
- Kirsehir Ahi Evran Universty
-
Kontakt:
- Edanur Tar Bolacalı, PhD
- Telefonnummer: +908504412483
- E-post: edanurtar.1107@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sleep Onset Latency
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Heart Rate
Tidsram: 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.
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Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
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Respiratory Rate
Tidsram: 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.
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Baseline, 15, 30, and 60 minutes after the intervention or routine care
|
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Oxygen Saturation (SpO₂)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 augusti 2026
Primärt slutförande (Beräknad)
15 oktober 2026
Avslutad studie (Beräknad)
30 december 2026
Studieregistreringsdatum
Först inskickad
21 juli 2026
Först inskickad som uppfyllde QC-kriterierna
21 juli 2026
Första postat (Faktisk)
24 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KAEU-NICU-2026-01
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