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

NCT06571006 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-14

No results posted yet for this 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.

Conditions

  • Infant ALL

Interventions

OTHER

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

Sponsors & Collaborators

  • Erzurum Technical University

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
32 Days
Max Age
40 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2025-11-01
Completion
2025-11-01

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 NCT06571006 on ClinicalTrials.gov