The Effect of Polyphonic Lullaby and Pish Pish Sound on Sleep Transition and Sleep Duration in Newborns

September 24, 2024 updated by: Sevgi Beyazgül
Sleep is the cornerstone of early development. Adequate sleep in children is important for proper growth, development and the child's health. Sleep is a dynamic process that develops and matures rapidly, especially in the first few years of life, from infancy to early adolescence. Daily sleep duration decreases with age, starting from the newborn period. At birth, babies show a sleep process that is compatible with their mothers' circadian rhythm. Newborns usually wake up in line with their nutritional needs and have short transitional sleep periods. At approximately 10-12 weeks of age, the first signs of circadian rhythm begin to develop and become apparent with increased sleep during the night. It has been reported that music positively affects mother-infant bonding, reduces babies' stress and creates positive physiological and behavioral changes. In a study examining mothers' views and practices on singing lullabies, it was seen that 87.6% of mothers said that singing lullabies soothes their children and prepares them for sleep, 88.3% prefer to sing lullabies before going to sleep while preparing their children for sleep, and 66.2% sing lullabies. Therefore, it is thought that the research will fill this gap in newborns.

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 is the cornerstone of early development. At approximately 10-12 weeks of age, the first signs of the circadian rhythm begin to develop and become evident with increased nighttime sleep. The change in the total 24-hour sleep duration decreases as the baby grows, gradually adapting to the circadian sleep rhythm. Daily sleep duration in newborns decreases to 16-17 hours, 14-15 hours at 16 weeks of age, and 13-14 hours at 6 months of age. As the baby grows, the need for daytime sleep decreases, resulting in a shift towards more nighttime sleep patterns. In recent years, studies examining the effects of music, especially on newborns, have increased. Music is a complex auditory stimulus consisting of various components such as melody, rhythm, timbre, and harmony. When adults listen to music, these components are perceived as a phenomenological whole, but they are processed separately through a complex dual cortical and subcortical regions. Since the adult human brain does not have a single musical center, the neural substrates supporting musical perception and production vary depending on the musical task. Neuroimaging studies in neonates or infants have reported inconsistent results regarding cortical activation in response to musical stimuli. While two studies showed weak bilateral responses to musical stimuli, results from a functional magnetic resonance imaging (fMRI) study used to measure brain activity in 1- to 3-day-old neonates hearing excerpts of Western tone music and modified versions of the same excerpts suggest that the infant brain shows hemispheric specialization in right-lateralized auditory cortex activity for processing music in the early postnatal hours, and that the neural architecture underlying music processing in neonates is sensitive to changes in tone key as well as differences in consonance and dissonance. It has been found that infants can maintain distinct memory traces for polyphonic music and show a high preference for polyphonic music from 3 months onwards. Marie and Trainor (2014) hypothesize that this high-volume advantage may be mediated at the level of the auditory nerve at birth. In general, the presence of immature mismatch negativity (MMN) occurs when there is an occasional change or deviant stimulus in a continuing standard stimulus sequence. Again, this more complex MMN-like response to polyphonic stimuli has been reported to have a longer developmental trajectory than the MMN elicited by a single tone stimulus. Early musical involvement is very important for the auditory system, which mostly matures in the first 6 months after birth. Polyphonic lullabies, known in the literature as polyphony consisting of sounds or music, are music played especially during the rapid development period (0-4 years) of infants and children. When the literature was examined, no randomized controlled studies were found that revealed the effects of polyphonic lullabies and piş piş sounds on the transition to sleep and sleep duration in healthy newborns. It was thought that the research results would provide strong evidence to support the development of approaches to improving sleep in newborns.

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.
81

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

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:

For newborns)

  • Being healthy
  • Being between 37th and 42nd weeks of gestation
  • Being between 2500-4000 kg at birth
  • Being exclusively breastfed for the first 3 months
  • Not having a hearing problem detected by the newborn hearing test Criteria for inclusion in the study (For mothers)
  • Not working for the first three months after birth
  • Not having any known chronic physical or mental problems
  • Not having any known sleep problems
  • Being literate
  • Being able to communicate in Turkish

Exclusion Criteria:

Exclusion criteria from the study (For newborns)

  • Having a congenital anomaly
  • Having a history of being in the neonatal intensive care unit
  • Having any health problems
  • Those who switched to mixed or formula feeding during the follow-up period

Exclusion criteria from the study (For newborns)

  • Those who develop any disease in the newborn (convulsion, upper respiratory tract infection, urinary tract infection, etc.)
  • Newborns in the experimental group who were not exposed to polyphonic lullaby/piş piş sounds for two consecutive days within 3 months and for a total of 5 days (Source.. I could not find a source here, lullaby studies conducted on preterm babies, if you want, I can add from those sources)
  • Newborns who did not fill out a regular weekly sleep diary
  • Newborns who were put to sleep by other sleep initiation methods such as breastfeeding or shaking to sleep other than the specified methods (polyphonic lullaby/piş piş sounds) will be excluded from 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: Double

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: Polyphonic Lullaby Group
After discharge, mothers will be asked to listen to the Dandini Dandini Dastana lullaby by singer Mircan Kaya, which they downloaded from the YouTube application, from a distance of one meter (away from the baby's head to minimize radioactive effects) and by turning the phone to airplane mode just before sleep. In case of active sleep transition (signs of sleep transition such as slowing down muscle movements and closing eyes), the polyphonic lullaby volume will be gradually reduced. The polyphonic lullaby will be lowered to 55 decibels for the first 5 minutes after falling asleep and then to 25 decibels and then turned off. In order to reduce the effect of confounding factors, mothers in the polyphonic lullaby group who used another assistive method (breastfeeding/rocking to sleep) to put their babies to sleep will be excluded from the scope of the study.
Behavioral: Polyphonic Lullaby Group
After discharge, mothers will be asked to play the Dandini Dandini Dastana lullaby by vocal artist Mircan Kaya, which they downloaded from the YouTube application, and listen to it from a distance of one meter (away from the baby's head to minimize radioactive effects) and by switching the phone to airplane mode just before sleep. In the event of active sleep (signs of sleep transition such as slowing down muscle movements and closing eyes), the polyphonic lullaby volume will be gradually reduced. The polyphonic lullaby will be played at a volume level of 55 decibels for the first 5 minutes after falling asleep, then reduced to 25 decibels and then turned off. In order to reduce the effects of confounding factors, mothers in the polyphonic lullaby group who use another assistive method (breastfeeding/rocking to sleep) to put their babies to sleep will be excluded from the study.
Experimental: Pish Pish Sound Group
After discharge, mothers will be asked to turn on the Piş Piş sound downloaded from the YouTube application and listen to it from a distance of one meter (away from the baby's head to minimize radioactive effects) and by turning the phone to airplane mode just before sleep. In case of active sleep (signs of sleep transition such as slowing down muscle movements and closing eyes), the piş piş sound will be gradually reduced. The polyphonic lullaby played will be at a volume level of 55 decibels for the first 5 minutes after falling asleep, then reduced to 25 decibels and then turned off. In order to reduce the effect of confounding factors, mothers in the piş piş sound group who use another assistive method (breastfeeding/rocking to sleep) to put their babies to sleep will be excluded from the scope of the research.
Other: Pish Pish Sound Group
After discharge, mothers will be asked to turn on the Piş Piş sound downloaded from the YouTube application and listen to it from a distance of one meter (away from the baby's head to minimize radioactive effects) and by turning the phone to airplane mode just before sleep. In case of active sleep (signs of sleep transition such as slowing down muscle movements and closing eyes), the piş piş sound will be gradually reduced. The polyphonic lullaby played will be at a volume level of 55 decibels for the first 5 minutes after falling asleep, then reduced to 25 decibels and then turned off. In order to reduce the effect of confounding factors, mothers in the piş piş sound group who use another assistive method (breastfeeding/rocking to sleep) to put their babies to sleep will be excluded from the scope of the research.
No Intervention: Model Group
The mothers in the control group will be given general sleep education on ensuring sleep hygiene before discharge, and brochures containing information on ensuring sleep hygiene will be distributed, and no other application will be made. In order to reduce the effect of confounding factors, the mothers in the control group will be asked at each interview whether they used any assistive methods to facilitate the transition to sleep, and newborns in the control group who were determined to use piş piş sounds or polyphonic lullabies will be excluded from the scope of the study.

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
Mother and baby information form
Time Frame: Must be taken 5 minutes before work.
It consists of a total of 22 questions developed by the researcher and his consultant based on literature, to determine the sociodemographic and descriptive characteristics that may affect the sleep pattern of babies. Before the data collection form is applied, it will be sent to experts in the field and expert opinions will be obtained.
Must be taken 5 minutes before work.

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
Extended BISQ Infant Short Sleep Questionnaire
Time Frame: Must be taken 10 minutes before work.
The expanded version of the "Infant Short Sleep Questionnaire" is a questionnaire developed by Sadeh in 2004 to screen for parenting practices, daytime and nighttime routines, sleep problems based on parental responses, and sleep environment during early childhood (0-36 months). The questionnaire has 13 items based on parental reports of the infant or toddler's sleep patterns. In addition, there are 4 items related to the sleep environment and 5 items assessing parents' perception of sleep problems.
Must be taken 10 minutes before work.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Diary
Time Frame: twice a week immediately after the procedure
A sleep diary was prepared by the researcher and his consultant in line with the literature so that the mothers could answer the questions in the BISQ questionnaire regarding sleep patterns as closely as possible to the truth: the time they started their bedtime routine, the time they went to bed, the number of times they woke up at night, the time they stayed awake at night, the longest sleep time spent without waking up at night, the total sleep time at night, and the number of daytime sleeps/naps.
twice a week immediately after the procedure
Infant Colic Scale
Time Frame: Must be taken 15 minutes before work.
The items of the infant colic scale were evaluated on a 6-point Likert scale. Scale items were rated with a Likert-type scoring system ranging from 1 to 6. The rating was made from 1 (strongly disagree) to 6 (strongly agree). Negative questions were reverse coded to ensure consistency in the interpretation of scores.
Must be taken 15 minutes before work.

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.
Sevgi Beyazgül

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.
October 1, 2024

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 1, 2025

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.
October 1, 2025

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).
September 22, 2024

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.
September 24, 2024

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.
September 26, 2024

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.
September 26, 2024

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.
September 24, 2024

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.
September 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 2024/239

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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