Search / Trial NCT06615323

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

Launched by SEVGI BEYAZGÜL · Sep 24, 2024

Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Newborn Polyphonic Lullaby Pish Pish Sound Sleep

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 ...

Gender

ALL

Eligibility criteria

  • 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.

About Sevgi Beyazgül

Sevgi Beyazgül is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a strong focus on ethical practices and regulatory compliance, Sevgi Beyazgül collaborates with leading healthcare professionals and institutions to design and implement clinical trials that address pressing healthcare challenges. By leveraging cutting-edge methodologies and fostering a patient-centered approach, the organization strives to contribute to the development of safe and effective therapies, ultimately enhancing the quality of life for individuals worldwide.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0