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

NCT06615323 | Not Yet Recruiting

• 1 other identifier: 2024/239
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Newborn; Vitality

Keywords

newborn; Polyphonic Lullaby; Pish Pish Sound; Sleep

Outcome Measures

Primary Outcomes (1)

• 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.

  Must be taken 5 minutes before work.

Secondary Outcomes (1)

• Extended BISQ Infant Short Sleep Questionnaire

  Must be taken 10 minutes before work.

Other Outcomes (2)

• Sleep Diary

  twice a week immediately after the procedure

• Infant Colic Scale

  Must be taken 15 minutes before work.

Study Arms (3)

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.

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.

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.

Interventions

Polyphonic Lullaby Group BEHAVIORAL

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.

Polyphonic Lullaby Group

Pish Pish Sound Group OTHER

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.

Pish Pish Sound Group

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sevgi Beyazgül: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: midwife

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09