Newborn; VitalityNCT06615323
The Effect of Polyphonic Lullaby and Pish Pish Sound on Sleep Transition and Sleep Duration in Newborns
A study testing Polyphonic Lullaby Group and Pish Pish Sound Group in people with Newborn; Vitality, run by Sevgi Beyazgül.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality
- What is being tested?
- Polyphonic Lullaby Group and Pish Pish Sound Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
- 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.
About this study
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.
Read the 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.
- Conditions
- Newborn; Vitality
- Being tested
- Polyphonic Lullaby Group, Pish Pish Sound Group
- Keywords
- newborn, Polyphonic Lullaby, Pish Pish Sound, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphonic Lullaby GroupBehavioural
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.
Pish Pish Sound GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Polyphonic Lullaby Group | Experimental | 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. Receives: Behavioral: Polyphonic Lullaby Group |
| Pish Pish Sound Group | Experimental | 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. Receives: Other: Pish Pish Sound Group |
| Model Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Mother and baby information form
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.
Measured: Must be taken 5 minutes before work.
Secondary outcomes (1)
Extended BISQ Infant Short Sleep Questionnaire
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.
Measured: Must be taken 10 minutes before work.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn; VitalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sevgi Beyazgül
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevgi Beyazgül, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615323
- Sponsor's protocol ID
- 2024/239
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Polyphonic Lullaby and Pish Pish Sound on Sleep Transition and Sleep Duration in Newborns
- ClinicalTrials.gov ID
- NCT06615323
- Acronym / sponsor ID
- 2024/239
- Conditions
- Newborn; Vitality
- Keywords
- newborn, Polyphonic Lullaby, Pish Pish Sound, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Sevgi BeyazgülUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polyphonic Lullaby Group | Experimental | Behavioral: Polyphonic Lullaby GroupAfter 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. |
| Pish Pish Sound Group | Experimental | Other: Pish Pish Sound GroupAfter 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. |
| Model Group | No intervention | –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. |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- Those who develop any disease in the newborn (convulsion, upper respiratory tract infection, urinary tract infection, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphonic Lullaby GroupAfter 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. | Behavioural | Polyphonic Lullaby Group |
| Pish Pish Sound GroupAfter 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 |
Primary outcome
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.
1 secondary outcome
Extended BISQ Infant Short Sleep Questionnaire
Time frame: Must be taken 10 minutes before work.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Related trials for Newborn; Vitality
Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)
RecruitingPhase 1/2
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
Extreme Prematurity, Enteral Nutrition
Active, not recruiting
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
Not yet recruiting
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Facial Wrinkles, Jawline Contour
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphonic Lullaby Group and Pish Pish Sound Group in people with Newborn; Vitality, run by Sevgi Beyazgül.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother and baby information form (time frame: Must be taken 5 minutes before work.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.