Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception
NCT Number: NCT06571006
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infant ALL
Interventions: OTHER: music
Sponsor: Erzurum Technical University
Sex: ALL
Age: CHILD
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-15
Completion Date: 2024-11-01
Locations: Ayşe Metin, Erzurum, 25010, Turkey

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.

Primary Outcome Measures: pain reduction, 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., 40 minute|vital signs: O2 Saturation, 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., 40 minute|vital signs: Heart rate, 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., 40 minute|baby's crying duration (sec), During the procedure, the baby's crying time will be tracked and recorded in seconds., 40 minute