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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 days
Maximum Age: 28 days
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Bartın University
RECRUITING
Bartın
Contact Information
Primary
Fatma Dinc, Asst.Prof
fatmadinc@bartin.edu.tr
+905383555685
Backup
Aylin Kurt, Asst.Prof
aylinkurt67@gmail.com
+905382087211
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2025-08-29
Participants
Target number of participants: 99
Treatments
Experimental: Heart sound group
In the heart sound group, the heart sound with an average heart rate of 70 beats is transmitted to the loudspeaker via an Mp3 player. Two small 200 W loudspeakers (SONY®)/JBL brand loudspeakers are used, placed on either side of the newborn's head, 30 cm from the newborn's ears.
Experimental: White noise group
In the white noise group, the mother of the baby is told that the white noise to be used in the study will be used for pain relief. For the white noise, the musician Osman Orhan's colic album, which was released by the production and often used in the literature. The song Bebeğiniz Ağlamasın Pt-3 from the album Kolik will be used (permission to use it in this work has been granted by ON Music Production). The volume is set to 45 db. The JBL loudspeaker is placed on the newborn's toe 5 minutes before the procedure, about 30 cm from the newborn's ear, and white noise is played 5 minutes before, during (at the 1st minute) and 5 minutes after the administration of the Hep B vaccine.
No_intervention: Control
Newborns in the control group will not receive any intervention other than Hepatitis B vaccination.
Sponsors
Leads: Bartın Unıversity

This content was sourced from clinicaltrials.gov