Infant ALLNCT06571006
Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception
A study testing music in people with Infant ALL, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 32 to 40 days
- Conditions the study is for
- Infant ALL
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 40 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having normal brainstem auditory responses
- Gestational age between 32-40
- Feeding the baby before the procedure
- Implementation of LP initiative
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception: Randomized Controlled Study
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.
Read the 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
- Being tested
- music
- Keywords
- lumbar puncture, Infant, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
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 group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | 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. Receives: Other: music |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 40 minute
baby's crying duration (sec)
During the procedure, the baby's crying time will be tracked and recorded in seconds.
Measured: 40 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start15 May 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Metin, Erzurum Technical University
- Investigators
- Ayşe Metin, phd, Study chair, kutuphane@erzurum.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571006
- Sponsor's protocol ID
- 227
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06571006
- Acronym / sponsor ID
- 227
- Conditions
- Infant ALL
- Keywords
- lumbar puncture, Infant, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Other: musicThe 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 | –no intervention |
Who may qualify
- Ages
- 32 to 40 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Having normal brainstem auditory responses
- Gestational age between 32-40
- Feeding the baby before the procedure
- Implementation of LP initiative
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musicThe 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 | Other | experiment group |
Primary outcome
pain reduction
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 40 minute
During the procedure, the baby's crying time will be tracked and recorded in seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Metin, phd study chair
kutuphane@erzurum.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Infant ALL, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain reduction (time frame: 40 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.