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Maternal Sensory Interventions in Newborns

NCT07725094 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-27

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Kirsehir Ahi Evran Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2026-10-15
Completion
2026-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725094 on ClinicalTrials.gov