Maternal Sensory Interventions in Newborns (MSI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Intensive Care Unit; Hospitalized Newborn
• Intervention / Treatment: Behavioral: Kangaroo Care; Behavioral: Maternal Lullaby; Behavioral: Maternal Tactile-Auditory Soothing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edanur Tar Bolacali, PhD; Phone Number: +908504412483; Email: edanurtar.1107@gmail.com
• Study Contact Backup: Name: Sibel Kucukoglu, PhD; Phone Number: +903322231623; Email: s_nadaroglu@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Kırşehir
    • Kırşehir, Kırşehir, Turkey (Türkiye), 40100
      • Kirsehir Ahi Evran Universty
      • Contact: Edanur Tar Bolacalı, PhD; Phone Number: +908504412483; Email: edanurtar.1107@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep-Wake States Assessed by Bispectral Index	Sleep-wake states will be assessed continuously using the Bispectral Index (BIS) monitor during the 60-minute observation period. BIS values will be classified as wakefulness (≥91), REM sleep (80-90), light sleep (55-79), and deep sleep (≤54). The duration and percentage of time spent in each sleep-wake state will be calculated.	During the 60-minute observation period following routine midday care and feeding
Sleep Onset Latency	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
Mean Bispectral Index Score	The mean BIS score will be calculated from BIS values recorded at one-minute intervals throughout the 60-minute monitoring period. Lower BIS scores indicate deeper sleep states.	During the 60-minute observation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	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	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)	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

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Newborn; Neonatal Intensive Care Unit; Kangaroo Care; Bispectral Index; Physiological Parameters; Lullaby; Maternal Sensory Intervention; Sleep-Wake States
• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Infant Care; Child Care; Patient Positioning; Kangaroo-Mother Care Method
• Other Study ID Numbers: KAEU-NICU-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No