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

NCT ID: NCT06571006

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2025-11-01

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.

Conditions

Infant ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

experiment group

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.

Group Type: EXPERIMENTAL

music

Intervention Type: OTHER

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

control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 32 Days
• Maximum Eligible Age: 40 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erzurum Technical University

OTHER

Sponsor Role: lead

Responsible Party

Ayşe Metin

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe Metin, phd

Role: STUDY_CHAIR

kutuphane@erzurum.edu.tr

Locations

Ayşe Metin

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

227

Identifier Type: -

Identifier Source: org_study_id