Using heart sounds and white noise to reduce pain during hepatitis B vaccination in newborns
The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection in Newborns: A Randomized Controlled Trial
This study is testing if playing heart sounds and white noise can help reduce pain for newborns getting their hepatitis B vaccine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 2 Days to 28 Days |
| Sex | All |
| Sponsor | Bartın Unıversity Academic / other |
| Locations | 1 site (Bartın) |
| Trial ID | NCT06279169 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of heart sounds and white noise on pain and physiological responses in newborns receiving the hepatitis B vaccine. It is a randomized controlled trial that compares the pain scores and physiological parameters, such as heart rate and oxygen saturation, between newborns exposed to these auditory stimuli and a control group. The study aims to determine if these interventions can effectively reduce pain and improve vital signs during vaccination procedures. The trial will be conducted at Bartın Maternity and Children's Hospital, with careful consideration of sample size and statistical power.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy newborns aged 2-28 days with stable vital signs and no contraindications to the hepatitis B vaccine.
Not a fit: Newborns requiring respiratory support or those with neurological disorders or significant congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the overall vaccination experience for newborns.
How similar studies have performed: This study is novel as there are no similar studies evaluating the effects of heart sounds and white noise on pain during hepatitis B vaccination in newborns.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bartın
- Bartın University — Bartın, Turkey (Recruiting)
Study contacts
- Study coordinator: Fatma Dinc, Asst.Prof
- Email: fatmadinc@bartin.edu.tr
- Phone: +905383555685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.