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

April 24, 2024 updated by: Fatma Dinç, Bartın Unıversity

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
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.
No Intervention: Control
Newborns in the control group will not receive any intervention other than Hepatitis B vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Newborn Infant Pain Scale (NIPS)
Time Frame: 15 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crying Time
Time Frame: 15 minutes
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
oxygen saturation
Time Frame: 15 minutes
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
heart rate
Time Frame: 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bartın Unıversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Estimated)

August 29, 2025

Study Completion (Estimated)

August 29, 2025

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-BRT-SBF-113355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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