Clinical trial NCT06571006: Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception
Official title: Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Infant ALL
Keywords: lumbar puncture
Infant
pain
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 25
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Bacterial meningitis is a serious infection that is more common in newborns than in other age groups and 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). Clinical suspicion of meningitis is greater in the presence of seizures, fever, swollen fontanelle, and abnormal consciousness, but initial symptoms are often vague in the neonatal period, especially in young infants. The United States and United Kingdom guidelines recommend performing LP in newborns and infants in cases of suspected sepsis and meningitis. There have been significant changes in our understanding of the pathophysiology of pain in children over the last 20 years. There is increasing evidence to suggest that neonates as young as 24 to 25 weeks of gestation have fully developed neural pathways for the transmission and perception of pain. Additionally, exposure to pain early in life can have both immediate and long-term detrimental effects on children. The realization that infants 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. Various studies have proven that listening to music, sounds and heartbeats can positively affect the physiological indicators, nutrition, length of stay and pain outcomes of newborn babies. Listening to music and parents' preferred lullabies can be used to objectively determine the effects of these interventions on premature newborns' heart rate, oxygen saturation, nutrient absorption, and calorie intake. 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 criteria: 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 outcomes:
measure: pain reduction
timeFrame: 40 minute
measure: vital signs: O2 Saturation
timeFrame: 40 minute
measure: vital signs: Heart rate
timeFrame: 40 minute
measure: baby's crying duration (sec)
timeFrame: 40 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ayşe Metin
Study officials:
affiliation: kutuphane@erzurum.edu.tr
name: Ayşe Metin, phd
role: STUDY_CHAIR
References: