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

NCT06279169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-04-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Bartın Unıversity

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2025-08-29
Completion
2025-08-29

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279169 on ClinicalTrials.gov