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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279169
• Other study ID #: 2023-BRT-SBF-113355
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2024
• Est. completion date: August 29, 2025

Study information

• Verified date: April 2024
• Source: Bartin University
• Contact: Fatma Dinc, Asst.Prof
• Phone: +905383555685
• Email: fatmadinc[@]bartin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The research hypotheses are H1: Neonates in the heart sound group will have lower procedural pain scores than neonates in the control group. H2: Neonates in the white noise group will have lower procedural pain scores than neonates in the control group. H3: Neonates in the heart sound group have lower procedural heart rate peak values than neonates in the control group. H4: Neonates in the white noise group have lower procedure-related peak heart rates than neonates in the control group. H5: Neonates in the heart sound group have higher procedural oxygen saturation values than neonates in the control group. H6: Neonates in the white noise group have higher procedural oxygen saturation values than neonates in the control group.

Methods The study was designed as a randomized controlled trial. The population of this study will consist of newborns who are followed up at Bartın Maternity and Children's Hospital. Statistical power, type I error, effect size, and study design will be taken into account when calculating the sample size. The study will be designed to have a power of at least 80% and a type I error rate of 5%. As there is no similar study evaluating the effect of heart tones and white noise on pain and physiological parameters during hepatitis B vaccination in children, the effect size of the study will be aimed at medium (0.25) to determine the sample size. Based on a medium effect size (f: 0.25), 80% (1 - β error) power and 95% (α error) confidence level, and taking into account data loss, it was calculated that the sample size should be increased by 10%, and the sample size of 33 newborns in each group should consist of 99 newborns in total G*Power 3.1.9.7.

Before starting the study, mothers will be informed about the purpose of the study and the heart sound and white noise applications to be applied and their written informed consent will be obtained. After written informed consent has been obtained from the mothers, the newborns will be randomised to 3 groups (heart sound, white noise, control group) by a statistician independent of the study (www. randomize.org) using a computer program. All newborns will receive a standardised approach. Standardised approach: All Hep B vaccine administration will be performed by a nurse during the morning shift and administered intramuscularly through the vastus lateralis muscle at a 90-degree angle using a 1-inch 23-gauge needle to infants in all three groups. All conditions such as room temperature (25°C), light, injection procedure will be the same in all three groups. Neonates will be fed at least 30 minutes before the procedure. Care will be taken to avoid non-nutritive sucking, touching or swaddling the baby during the procedure to avoid confusion with other pain relief methods. Aseptic techniques are observed during all procedures.

During the implementation of the measurement tools, the researcher will go to the relevant facility herself and the data collection forms will be applied face to face. The researcher and the nurse will not use any aromatic substances in the baby monitoring room during the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: August 29, 2025
• Est. primary completion date: August 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Hepatitis B
• Newborn; Vitality
• Pain, Acute

Intervention

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
• White Noise
Musician Osman Orhan's song "Bebeginiz Aglamasin" from his album Kolik will be used for white noise. The volume will be set to 45 db.

Locations

Country	Name	City	State
Turkey	Bartin University	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	oxygen saturation	In each group, oxygen saturation of the newborns to be included in the study will be performed by the same researcher with the same calibrated pulseoximeter device in the infant monitoring unit.	15 minutes
Secondary	heart rate	The heart rate measurements of the newborns to be included in the study in each group will be performed by the same researcher with the same calibrated device in the infant monitoring unit.	15 minutes
Secondary	Crying Time	During the Hep B vaccination procedure, a stopwatch will be started from the moment the newborn starts crying. "Samsung" brand "Note 10" model phone stopwatch will be used for the stopwatch. During the procedure, the stopwatch will be turned on when the baby cries, and the stopwatch will be stopped when the crying stops.	15 minutes