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NCT Number: NCT07725094

Maternal Sensory Interventions in Newborns

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.

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Key information

Age range

35 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Sleep-Wake States Assessed by Bispectral Index

    Time frame: 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.

  2. Sleep Onset Latency

    Time frame: 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.

  3. Mean Bispectral Index Score

    Time frame: 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.

Secondary outcomes

  1. Heart Rate

    Time frame: 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.

  2. Respiratory Rate

    Time frame: 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.

  3. Oxygen Saturation (SpO₂)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edanur Tar Bolacali, PhD

CONTACT

[email protected]

+908504412483

Sibel Kucukoglu, PhD

CONTACT

[email protected]

+903322231623

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

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

Acronym: MSI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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