Maternal Sensory Interventions in Newborns (MSI)

July 24, 2026 updated by: Edanur Tar Bolacali, Kirsehir Ahi Evran Universitesi

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group 1: Kangaroo Care
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
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.
Experimental: Intervention Group 2: Maternal Lullaby
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
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.
Experimental: Intervention Group 3: Maternal Tactile-Auditory Soothing
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
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.
No Intervention: Routine Care (Control)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the beginning of the intervention until sleep onset, assessed within 60 minutes
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.
During the 60-minute observation period following routine midday care and feeding
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.
During the 60-minute observation period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 15, 30, and 60 minutes after the intervention or routine care
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.
Baseline, 15, 30, and 60 minutes after the intervention or routine care
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.
Baseline, 15, 30, and 60 minutes after the intervention or routine care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirsehir Ahi Evran Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAEU-NICU-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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