RECRUITINGINTERVENTIONAL

The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection

The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection in Newborns: A Randomized Controlled Trial

About This Trial

It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design.

Who May Be Eligible (Plain English)

Who May Qualify: - Gestational age of 38-41 weeks, - Newborn birth weight \>2500 g - Stable vital signs before the procedure, - Postanatal age between 2-28 days, - No contraindications to the administration of hepatitis B vaccine - Delivery of the newborn to the mother after birth - Consent of the parents of the newborn to participate in the study - Fasting less than 3 hours/30 minutes before feeding - A valid score on the newborn hearing screening test - Newborn not crying before vaccination Who Should NOT Join This Trial: - Newborn babies requiring respiratory support, - Newborns with any neurological disorder (seizures) - Newborns taking opiates or born to mothers taking opiates - Newborns receiving muscle relaxants, sedatives, analgesics - Babies with major congenital anomalies - Neonates with an APGAR score of less than 7 at 5 minutes - Neonates who have undergone surgery - Newborns with birth trauma (especially rapid delivery) - Conditions that may prevent communication with parents (e.g. speech problem) - Hearing impairment - Newborns who will be transferred to another hospital Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Gestational age of 38-41 weeks, * Newborn birth weight \>2500 g * Stable vital signs before the procedure, * Postanatal age between 2-28 days, * No contraindications to the administration of hepatitis B vaccine * Delivery of the newborn to the mother after birth * Consent of the parents of the newborn to participate in the study * Fasting less than 3 hours/30 minutes before feeding * A valid score on the newborn hearing screening test * Newborn not crying before vaccination Exclusion Criteria: * Newborn babies requiring respiratory support, * Newborns with any neurological disorder (seizures) * Newborns taking opiates or born to mothers taking opiates * Newborns receiving muscle relaxants, sedatives, analgesics * Babies with major congenital anomalies * Neonates with an APGAR score of less than 7 at 5 minutes * Neonates who have undergone surgery * Newborns with birth trauma (especially rapid delivery) * Conditions that may prevent communication with parents (e.g. speech problem) * Hearing impairment * Newborns who will be transferred to another hospital

Treatments Being Tested

BEHAVIORAL

Heart Sound

In the Heart sound group, this sound will be played to the newborn 5 minutes before Hep B vaccine administration, during the procedure (at 1 minute) and 5 minutes after Hep B vaccine administration

BEHAVIORAL

White Noise

Musician Osman Orhan's song "Bebeğiniz Ağlamasın" from his album Kolik will be used for white noise. The volume will be set to 45 db.

Locations (1)

Bartın University

Bartın, Turkey (Türkiye)