Ireland
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Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception

NCT06571006 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-05-15
Last updated
2025-08-14

Condition(s) studied

Infant ALL

Investigational drug(s) / intervention(s)

music

music: The musical intervention will start 10 minutes before the lumbar puncture procedure begins and continue for another 20 minutes after the intervention. Babies will be kept away from noise during this study. W.A. It was decided to use the piece "Adagio" from the Violin Concerto No. 3 in G major, KV 216, composed by Mozart. The track will be played through two speakers on opposite sides, 30 cm away from the baby's ears, to optimize sound perception. High quality digital audio will be used to make babies listen. Music will be played at a level that can be heard in high noise pollution (i.e. the noise of incubator operation and the white noise of the recorder), but taking into account the permissible sound level recommended by the American Academy of Pediatrics, i.e. 65-70 dB

Study summary

Bacterial meningitis is a serious infection that is more common in newborns is associated with significant morbidity and mortality. The gold standard for the diagnosis of bacterial meningitis is a positive cerebrospinal fluid (CSF) culture, usually obtained via lumbar puncture (LP). İnfants and children have similar physiological responses to pain as adults has led to greater emphasis on the assessment and management of pain in children. Therefore, management of painful interventions is important. Music may improve oxygen saturation in preterm infants undergoing endotracheal suctioning and may also reduce stress and pain in children undergoing painful medical procedures such as intravenous injections, lumbar punctures, and dental procedures. Although there are studies in the literature examining the effect of music therapy on heel blood collection or intravenous injection, no study has been found examining the effect of music therapy on the baby's pain perception during lumbar puncture. The aim of this study is to examine whether music therapy applied during lumbar puncture affects the baby's reactions to pain.

Eligibility

Sex
ALL
Min age
32 Days
Max age
40 Days
Healthy volunteers
No
Inclusion Criteria: * Having normal brainstem auditory responses * Gestational age between 32-40 * Feeding the baby before the procedure * Implementation of LP initiative Exclusion Criteria: * Having a genetic diagnosis * Having a neurometabolic diagnosis * Congenital malformations, mechanical ventilation, asphyxia, anomalies associated with neurological disorders, use of sedatives, or other comorbid conditions that may affect the response to musical stimuli or data collection

Primary outcome measure(s)

  • pain reduction — 40 minute
    pain relief Neonatal Infant Pain Scale (NIPS), which is a behavioral assessment tool for measuring pain in preterm and term newborns, was developed by Lawrence et al. (1993). Cronbach's alpha value was found to be 0.95 before the procedure, 0.87 during the procedure, and 0.88 after the procedure (Lawrence et al., 1993). Turkish validity and reliability were determined by Akdovan (1999). This scale was created to measure the response of the term or preterm newborn to procedural pain or distress.Parameters include babies' facial expressions, crying, breathing patterns, arm movements, leg movements, and arousal state.The total score varies between 0 and 7. Higher scores indicate higher pain levels. In other words, as the score increases, the severity of pain also increases. 0-2 points indicate no pain/mild pain, 3-4 points indicate mild pain/moderate pain, and \>4 points indicate severe pain.
  • vital signs: O2 Saturation — 40 minute
    O2 Saturation Using an oximeter, arterial oxygen saturation (SaO2) will be measured and recorded from 10 minutes before the procedure until the end of the procedure. Babies' oxygen saturations will be measured with a pulse oximeter placed on the wrist and monitored. All babies in the neonatal intensive care unit are constantly monitored with a monitor device. The will be monitored and recorded using this monitor. The value will be recorded 10 minutes before the transaction, during the transaction, 10 minutes after the transaction and 20 minutes after the transaction.
  • vital signs: Heart rate — 40 minute
    Heart rate (beats per minute) All babies in the neonatal intensive care unit are constantly monitored with a monitor device. The babies' heart rate per minute will be monitored and recorded using this monitor. The value will be recorded 10 minutes before the transaction, during the transaction, 10 minutes after the transaction and 20 minutes after the transaction.
  • baby's crying duration (sec) — 40 minute
    During the procedure, the baby's crying time will be tracked and recorded in seconds.

Trial sites (1)

FacilityCityRegionStatus
Ayşe Metin Erzurum Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06571006 on ClinicalTrials.gov ↗ ← All trials in Turkey