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

NCT06279169 | Recruiting

• 1 other identifier: 2023-BRT-SBF-113355
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Acute; Newborn; Vitality

Keywords

Pain; Acute Pain

Outcome Measures

Primary Outcomes (1)

• The Newborn Infant Pain Scale (NIPS)

  Used to assess behavioral and physiological pain responses of preterm and term infants. The Neonatal Infant Pain Scale is a Likert-type scale consisting of 6 parameters including facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; moaning, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0; relaxed-free, 1; flexion-extension), leg (0; relaxed-free, 1; flexion-extension) and sleep-wakefulness (0; sleep-wakefulness peaceful, 1; restless). According to the scale, 7 is interpreted as the highest level of pain and 0 as the lowest level of pain. A high score indicates greater severity of pain.

  15 minutes

Secondary Outcomes (3)

• oxygen saturation

  15 minutes

• heart rate

  15 minutes

• Crying Time

  15 minutes

Study Arms (3)

Heart sound group

EXPERIMENTAL

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.

Behavioral: Heart Sound

White noise group

EXPERIMENTAL

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.

Behavioral: White Noise

Control

NO INTERVENTION

Newborns in the control group will not receive any intervention other than Hepatitis B vaccination.

Interventions

Heart Sound BEHAVIORAL

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

Heart sound group

White Noise BEHAVIORAL

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.

White noise group

Eligibility Criteria

• Age: 2 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

Bartın University

Bartın, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Heart Sounds

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Fatma Dinc, Asst.Prof

CONTACT

+905383555685; fatmadinc@bartin.edu.tr

Aylin Kurt, Asst.Prof

CONTACT

+905382087211; aylinkurt67@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 26, 2024
• Study Start: April 24, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)