Maternal Sensory Interventions in Newborns

NCT07725094 | Not Yet Recruiting

• 1 other identifier: KAEU-NICU-2026-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Intensive Care Unit; Hospitalized Newborn

Keywords

Bispectral Index; Kangaroo Care; Lullaby; Maternal Sensory Intervention; Newborn; Neonatal Intensive Care Unit; Physiological Parameters; Randomized Controlled Trial; Sleep-Wake States

Outcome Measures

Primary Outcomes (3)

• Sleep-Wake States Assessed by Bispectral Index

  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

• 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 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

Secondary Outcomes (3)

• Heart Rate

  Baseline, 15, 30, and 60 minutes after the intervention or routine care

• Respiratory Rate

  Baseline, 15, 30, and 60 minutes after the intervention or routine care

• Oxygen Saturation (SpO₂)

  Baseline, 15, 30, and 60 minutes after the intervention or routine care

Study Arms (4)

Intervention Group 1: Kangaroo Care

EXPERIMENTAL

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

Intervention Group 2: Maternal Lullaby

EXPERIMENTAL

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

Intervention Group 3: Maternal Tactile-Auditory Soothing

EXPERIMENTAL

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

Routine Care (Control)

NO INTERVENTION

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.

Interventions

Kangaroo Care BEHAVIORAL

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.

Intervention Group 1: Kangaroo Care

Maternal Tactile-Auditory Soothing BEHAVIORAL

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.

Intervention Group 3: Maternal Tactile-Auditory Soothing

Maternal Lullaby BEHAVIORAL

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.

Intervention Group 2: Maternal Lullaby

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kirsehir Ahi Evran Universty

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31397094 RESULT

• 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.

  RESULT

• 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.

  PMID: 34713833 RESULT

• 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.

  PMID: 35634367 RESULT

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Edanur Tar Bolacali, PhD

CONTACT

+908504412483; edanurtar.1107@gmail.com

Sibel Kucukoglu, PhD

CONTACT

+903322231623; s_nadaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: Kangaroo Care, Maternal Lullaby, Maternal Tactile-Auditory Soothing, or Routine Care. Each participant will receive only the intervention assigned to their group, and outcomes will be compared between groups.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)