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Maternal Sensory Interventions in Newborns

ConditionsNeonatal Intensive Care UnitHospitalized Newborn
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-42
SponsorKirsehir Ahi Evran Universitesi

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Intervention Group 1: Kangaroo CareExperimental treatment 1 intervention
Group B: Intervention Group 2: Maternal LullabyExperimental treatment 1 intervention
Group C: Intervention Group 3: Maternal Tactile-Auditory SoothingExperimental treatment 1 intervention
Group D: Routine Care (Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During the 60-minute observation period following routine midday care and feeding
2

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.

Time frame
From the beginning of the intervention until sleep onset, assessed within 60 minutes
3

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.

Time frame
During the 60-minute observation period

Secondary outcomes

1

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.

Time frame
Baseline, 15, 30, and 60 minutes after the intervention or routine care
2

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.

Time frame
Baseline, 15, 30, and 60 minutes after the intervention or routine care
3

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirsehir Ahi Evran Universitesi

Lead sponsor

Source ClinicalTrials.gov

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