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 May 18, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how two soothing sounds—polyphonic lullabies and "pish pish" sounds—can help newborns transition to sleep and improve how long they sleep. Sleep is very important for a baby's growth and health, especially in the early weeks and months. Researchers want to see if these gentle sounds can help babies feel calmer and sleep better, which may also help strengthen the bond between mothers and their babies.
To participate in the trial, newborns must be healthy, born between 37 and 42 weeks of pregnancy, and weigh between 2,500 and 4,000 grams at birth. They also need to be exclusively breastfed for the first three months and pass a hearing test. Mothers participating in the study should not have any major health issues, work during the first three months after birth, or have sleep problems. If eligible, families can expect to help with recording their baby's sleep patterns while using the lullabies and sounds. This study could provide valuable insights into improving sleep for newborns and their families.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported