Maternal Sensory Interventions in Newborns | NCT07725094

NCT07725094

Overview

NCT ID: NCT07725094
Lead Sponsor: Kirsehir Ahi Evran UniversitesiOTHER
Official 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
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
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 15, 2026Estimated
Primary Completion Date: Oct 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 80Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Edanur Tar Bolacali, PhDContact
edanurtar.1107@gmail.com+908504412483

Similar Studies

Participant Group/Arms

Intervention Group 1: Kangaroo CareExperimental

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 LullabyExperimental

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 SoothingExperimental

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.