NeonatalNCT05828420
The Effect of Music, White Noise and Heart Sound on Neonatal Pain
A study testing White noise, Heart sound and Music in people with Neonatal and Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Infants are exposed to many painful procedures during their stay in the Neonatal Intensive Care Unit (NICU). Some epidemiological studies report that infants experience an average of 7.5-14 painful procedures per day per infant during the first 14 days of their hospitalization. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- What is being tested?
- White noise, Heart sound and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 27 Feb 2023
- 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 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having a 28-42 weeks preterm or term newborn
- No sedative or analgesic given in the last 6 hours
- Parental consent for inclusion in the study in line with participant information and consent form.
Who cannot join
- Presence of intracranial bleeding
- Having cerebral hypoxic ischemia
- Babies whose blood cannot be drawn on the first try
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music the Mother Listened to During Her Pregnancy, White Noise and Heart Sound on Neonatal Pain During Heel Lance
Infants are exposed to many painful procedures during their stay in the Neonatal Intensive Care Unit (NICU). Some epidemiological studies report that infants experience an average of 7.5-14 painful procedures per day per infant during the first 14 days of their hospitalization.
The most significant problem encountered in understanding pain in infants is the lack of verbal expression of pain. Newborns express their pain with nonverbal behavioral expressions. Therefore, any pain assessment is based on the ability to recognize the pain symptoms of others. The pain experienced may cause physiological imbalances and abnormalities in brain development and stress response in infants in the short and long term. It can negatively affect family-infant communication, as well as cause emotional and psychosomatic problems later in life.
Read more
Today, music therapy has positive effects on reducing stress, reducing pain, oxygen saturation level, and peak heart rate values in providing individualized developmental care of the infant in neonatal intensive care units. Heart sound, babies hear the mother's heart sound the most during the intrauterine period in the womb. Therefore, when babies hear the sound, they are familiar with in the womb, they will feel safe and a sense of relaxation will occur in the baby. Several studies have proven that playing heartbeat sounds to newborn babies can positively affect their physiological indicators, feeding, length of hospital stay and pain outcomes. The current literature shows that the presence of rhythmic sound can positively affect the neurobehavioral development of the infant and reduce pain. Rhythmic sounds have healing/positive effects on newborns; listening to white noise reduces preterms' pain scores, stabilizes vital signs, and plays an active role in preterms' sleep-wake period.
In line with all this information, this study was carried out as a randomized controlled experimental study in order to determine the effects of music played during heel spear application, white noise and heart sound in infants.
Read the detailed description
The purpose of the study is to determine the effect of white noise, heart sound, and music on reducing neonatal pain during heel lance.
The design of the study is a randomized controlled experimental design. The sample of the study consisted of 84 infants with a gestational age of 28-42 weeks. The infants were exposed to white noise, heart sounds, or the music that the mother listened to most frequently during pregnancy for 10 minutes before the heel lance, during, and 20 minutes after the procedure. The pain of the infants before, during, and after the procedure was measured using the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). Also, the duration of the procedure and the crying time were evaluated.
- Being tested
- White noise, Heart sound, Music
- Keywords
- Music, Neonatal, pain, white noise, heel lance, heart sound
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White noiseOther
Each baby was listened to white noise 10 minutes before, during and 20 minutes after the painful attempt.
Heart soundOther
Each baby listened to heart sounds at an average rate of 70 beats 10 minutes before, during and 20 minutes after the painful procedure.
MusicOther
Each baby was listened to the music that the mother listened to the most during pregnancy restriction 10 minutes before, during and after the painful attempt.
| Study group | Role | What they receive |
|---|---|---|
| The pain effect of listening to white noise on newborn babies | Experimental | Each baby was listened to white noise 10 minutes before, during and 20 minutes after the painful attempt. Receives: Other: White noise |
| The pain effect of listening to heart sound on newborn babies | Experimental | Each baby listened to heart sounds at an average rate of 70 beats 10 minutes before, during and 20 minutes after the painful procedure. Receives: Other: Heart sound |
| The pain effect of listening to music on newborn babies | Experimental | Each baby was listened to the music that the mother listened to the most during pregnancy restriction 10 minutes before, during and after the painful attempt. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIAPAS pain score
The Neonatal Infant Acute Pain Assessment Scale (NIAPAS) was used to measure the pain of newborns. The score that can be obtained from scoring the indicators is between 0-18. The indicators can be scored with 2 (0,1), 3 (0,1,2) or 4 (0,1,2,3) grades. Painful procedures are evaluated in three stages. Pain intensity is classified as mild (0-5), moderate (6-9), and severe pain (10-18).
Measured: 2 year
Secondary outcomes (1)
Crying time
Infant's crying time were calculated by watching the video recordings. Pain assessment of the infants was performed by two independent neonatal nurses, different from the researcher, by watching the video recordings.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Oct 2020
- Primary completion30 Jan 2021
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatalStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birsen Mutlu, Istanbul University - Cerrahpasa
- Investigators
- Birsen Mutlu, Principal investigator, İstanbul Universty-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828420
- Sponsor's protocol ID
- bdonmez@iuc.edu.tr
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music the Mother Listened to During Her Pregnancy, White Noise and Heart Sound on Neonatal Pain During Heel Lance
- ClinicalTrials.gov ID
- NCT05828420
- Acronym / sponsor ID
- bdonmez@iuc.edu.tr
- Keywords
- Music, Neonatal, pain, white noise, heel lance, heart sound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 25 Apr 2023 (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.
Infants are exposed to many painful procedures during their stay in the Neonatal Intensive Care Unit (NICU). Some epidemiological studies report that infants experience an average of 7.5-14 painful procedures per day per infant during the first 14 days of their hospitalization.
The most significant problem encountered in understanding pain in infants is the lack of verbal expression of pain. Newborns express their pain with nonverbal behavioral expressions. Therefore, any pain assessment is based on the ability to recognize the pain symptoms of others. The pain experienced may cause physiological imbalances and abnormalities in brain development and stress response in infants in the short and long term. It can negatively affect family-infant communication, as well as cause emotional and psychosomatic problems later in life.
Today, music therapy has positive effects on reducing stress, reducing pain, oxygen saturation level, and peak heart rate values in providing individualized developmental care of the infant in neonatal intensive care units. Heart sound, babies hear the mother's heart sound the most during the intrauterine period in the womb. Therefore, when babies hear the sound, they are familiar with in the womb, they will feel safe and a sense of relaxation will occur in the baby. Several studies have proven that playing heartbeat sounds to newborn babies can positively affect their physiological indicators, feeding, length of hospital stay and pain outcomes. The current literature shows that the presence of rhythmic sound can positively affect the neurobehavioral development of the infant and reduce pain. Rhythmic sounds have healing/positive effects on newborns; listening to white noise reduces preterms' pain scores, stabilizes vital signs, and plays an active role in preterms' sleep-wake period.
In line with all this information, this study was carried out as a randomized controlled experimental study in order to determine the effects of music played during heel spear application, white noise and heart sound in infants.
Detailed description
The purpose of the study is to determine the effect of white noise, heart sound, and music on reducing neonatal pain during heel lance.
The design of the study is a randomized controlled experimental design. The sample of the study consisted of 84 infants with a gestational age of 28-42 weeks. The infants were exposed to white noise, heart sounds, or the music that the mother listened to most frequently during pregnancy for 10 minutes before the heel lance, during, and 20 minutes after the procedure. The pain of the infants before, during, and after the procedure was measured using the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). Also, the duration of the procedure and the crying time were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The pain effect of listening to white noise on newborn babies | Experimental | Other: White noiseEach baby was listened to white noise 10 minutes before, during and 20 minutes after the painful attempt. |
| The pain effect of listening to heart sound on newborn babies | Experimental | Other: Heart soundEach baby listened to heart sounds at an average rate of 70 beats 10 minutes before, during and 20 minutes after the painful procedure. |
| The pain effect of listening to music on newborn babies | Experimental | Other: MusicEach baby was listened to the music that the mother listened to the most during pregnancy restriction 10 minutes before, during and after the painful attempt. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Having a 28-42 weeks preterm or term newborn
- No sedative or analgesic given in the last 6 hours
- Parental consent for inclusion in the study in line with participant information and consent form.
Key exclusion criteria (3 listed)
- Presence of intracranial bleeding
- Having cerebral hypoxic ischemia
- Babies whose blood cannot be drawn on the first try
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 |
|---|---|---|
| White noiseEach baby was listened to white noise 10 minutes before, during and 20 minutes after the painful attempt. | Other | The pain effect of listening to white noise on newborn babies |
| Heart soundEach baby listened to heart sounds at an average rate of 70 beats 10 minutes before, during and 20 minutes after the painful procedure. | Other | The pain effect of listening to heart sound on newborn babies |
| MusicEach baby was listened to the music that the mother listened to the most during pregnancy restriction 10 minutes before, during and after the painful attempt. | Other | The pain effect of listening to music on newborn babies |
Primary outcome
NIAPAS pain score
Time frame: 2 year
The Neonatal Infant Acute Pain Assessment Scale (NIAPAS) was used to measure the pain of newborns. The score that can be obtained from scoring the indicators is between 0-18. The indicators can be scored with 2 (0,1), 3 (0,1,2) or 4 (0,1,2,3) grades. Painful procedures are evaluated in three stages. Pain intensity is classified as mild (0-5), moderate (6-9), and severe pain (10-18).
1 secondary outcome
Crying time
Time frame: 2 year
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 25 Apr 2023.
- 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.
Birsen Mutlu principal investigator
İstanbul Universty-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White noise, Heart sound and Music in people with Neonatal and Pain, run by Istanbul University - Cerrahpasa 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 3 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 25 Apr 2023. 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?
NIAPAS pain score (time frame: 2 year). 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 25 Apr 2023.