Neonatal DiseaseNCT06408064
The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate
A study testing Music therapy in people with Neonatal Disease, run by Claudia Aristizábal at 1 site in Colombia.
Trial summary
The admission of a newborn to the neonatal intensive care unit (NICU) represents a potentially harmful sound environment coupled with multiple stressful events. However, a strategy such as music therapy (delivered by a trained music therapist) appears to be a non-invasive, safe, and cost-effective alternative that… Read more about this study
- Who is it for?
- Ages 32 to 40 weeks
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteColombia
- Study dates
- 3 May 2024to 18 Jul 2024
- 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 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with gestational age at birth greater than or equal to 32 weeks.
- Birth weight greater than or equal to 1500 grams.
- Be at least 72 hours of postnatal age.
Who cannot join
- Respiratory disturbances in the last 48 hours such as: Apnea or Brief Resolved Unexplained Events (BRUE), need for invasive mechanical ventilation
- Hemodynamic alterations in the last 48 hours such as: Hypotension (systolic, diastolic, or mean BP < P5) or hypertension (systolic, diastolic, or mean BP > P95), bradycardia (HR < 100/min), shock of any etiology, requirement for volume expanders, infusion of inotropics, vasodilators and/or prostaglandin E1.
- Neurological alterations such as: Perinatal asphyxia at birth manifested by the need for resuscitation, APGAR < 3 at 5 minutes and/or ≤ 5 at 10 minutes, and metabolic acidosis in cord gases with a potential of hydrogen (pH) < 7 and base excess (BE) < -12, hypoxic-ischemic encephalopathy, seizure syndrome for up to 48 hours after the last clinical event or alteration of the brain pattern, interventricular hemorrhage in preterm infants in the first week of diagnosis.
- Management with Extracorporeal membrane oxygenation (ECMO) and/or nitric oxide
- Temperature less than 36.5 C or greater than 37.5 C.
- Patient under pharmacological sedation or use of beta-blockers.
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- Congenital heart disease, operated on or not.
- Congenital malformations
- Surgical emergencies or recovery from a surgical procedure performed within the last 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
The admission of a newborn to the neonatal intensive care unit (NICU) represents a potentially harmful sound environment coupled with multiple stressful events. However, a strategy such as music therapy (delivered by a trained music therapist) appears to be a non-invasive, safe, and cost-effective alternative that assists newborns in their physiological self-regulation with a beneficial effect on stabilizing neonatal vital signs, so it can be used as a complementary strategy to medical management. The aim of this study is to determine the effect of live and pre-recorded music therapy on vital sign variables in newborns older than 32 weeks hospitalized in the neonatal intensive care unit of a high-complexity health institution in Colombia.
Read the detailed description
A parallel, controlled randomized clinical trial will be conducted.
Study Population: Newborns older than 32 weeks gestational age at birth hospitalized in the Neonatal Intensive Care Unit of a high-complexity health institution who meet the inclusion criteria.
Outcomes: Heart rate will be primary outcome. Respiratory rate and oxygen saturation will be secondary outcomes. The patient monitor will be utilized to measure the heart rate, respiratory rate, and oxygen saturation.
Standardization of measurements:
First, the trademarks of the medical equipment manufacturers of each of the tools that will be used (vital sign monitor and pulse oximeter) will be verified to ensure that they correspond to the same commercial brand. Since different brands may exhibit variability in standard calibration measurements within the critical range, it is important to verify that the tools are of the same brand. Secondly, it will be verified that each medical tool used has been calibrated within the previous six months, with the date of the last calibration recorded so that the device can be used during the study. Subsequently, the professional in charge of the music company will verify that the guitar to be used during the live music is in tune and suitable for use. A decibel regulator will be employed during the implementation of both pre-recorded and live music, adjusting the volume of the emitted sound. This will ensure that the decibels emitted by each research subject remain within the permitted range of 70 decibel (dB). Vital variables will be recorded at minute 0, from minute 0 to minute 10 continuously, and at 30 minutes after the intervention.
- Conditions
- Neonatal Disease
- Being tested
- Music therapy
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Music therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded instrumental lullabies music.The volume control will be conducted within the groups through the use of a decibel regulator, with a maximum volume of 70 dB. During the intervention and for a period of 30 minutes following its conclusion, singing will be prohibited by the music therapist or the parents. Both live and pre-recorded music will be instrumental in nature, lacking any lyrics.
| Study group | Role | What they receive |
|---|---|---|
| Live music | Experimental | It is performed by a music therapist using the guitar as the only musical instrument. Instrumental lullabies are used, selected by the patient's legal guardian. Receives: Other: Music therapy |
| Pre-recorded music | Experimental | Pre-recorded music of the lullaby genre, instrumental type, using a speaker placed inside the patient's incubator. Receives: Other: Music therapy |
| Control | No intervention | There will be no musical intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
The measurement will be continuously quantified in terms of number of pulsations per minute continuously.
Measured: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
Secondary outcomes (2)
Respiratory rate
The measurement will be continuously quantified in terms of the number of breaths per minute.
Measured: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
Oxygen saturation
The measurement will be continuously quantified in terms of proportion per minute.
Measured: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start3 May 2024
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Music therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded music. Group A will be that of patients exposed to live music, which will be carried out by a music therapist using the guitar as the only musical instrument. Instrumental lullabies will be used, which will be selected by the patients' legal guardians. Group B corresponds to patients who will be exposed to pre-recorded music, of the genre of lullabies, instrumental type, using a speaker that will be placed inside the patient's incubator. Group C will be those patients in whom no musical intervention will be performed.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- Sanitas University
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
- Investigators
- Johana Benavides, MSc, Study director, Unisanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408064
- Sponsor's protocol ID
- CEIFUS 470-24
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the study ends, individual participant data could be shared with the approval of the research ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate
- ClinicalTrials.gov ID
- NCT06408064
- Acronym / sponsor ID
- CEIFUS 470-24
- Conditions
- Neonatal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- Sanitas University
- Study start
- 3 May 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 9 May 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.
The admission of a newborn to the neonatal intensive care unit (NICU) represents a potentially harmful sound environment coupled with multiple stressful events. However, a strategy such as music therapy (delivered by a trained music therapist) appears to be a non-invasive, safe, and cost-effective alternative that assists newborns in their physiological self-regulation with a beneficial effect on stabilizing neonatal vital signs, so it can be used as a complementary strategy to medical management. The aim of this study is to determine the effect of live and pre-recorded music therapy on vital sign variables in newborns older than 32 weeks hospitalized in the neonatal intensive care unit of a high-complexity health institution in Colombia.
Detailed description
A parallel, controlled randomized clinical trial will be conducted.
Study Population: Newborns older than 32 weeks gestational age at birth hospitalized in the Neonatal Intensive Care Unit of a high-complexity health institution who meet the inclusion criteria.
Outcomes: Heart rate will be primary outcome. Respiratory rate and oxygen saturation will be secondary outcomes. The patient monitor will be utilized to measure the heart rate, respiratory rate, and oxygen saturation.
Standardization of measurements:
First, the trademarks of the medical equipment manufacturers of each of the tools that will be used (vital sign monitor and pulse oximeter) will be verified to ensure that they correspond to the same commercial brand. Since different brands may exhibit variability in standard calibration measurements within the critical range, it is important to verify that the tools are of the same brand. Secondly, it will be verified that each medical tool used has been calibrated within the previous six months, with the date of the last calibration recorded so that the device can be used during the study. Subsequently, the professional in charge of the music company will verify that the guitar to be used during the live music is in tune and suitable for use. A decibel regulator will be employed during the implementation of both pre-recorded and live music, adjusting the volume of the emitted sound. This will ensure that the decibels emitted by each research subject remain within the permitted range of 70 decibel (dB). Vital variables will be recorded at minute 0, from minute 0 to minute 10 continuously, and at 30 minutes after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Music therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded music. Group A will be that of patients exposed to live music, which will be carried out by a music therapist using the guitar as the only musical instrument. Instrumental lullabies will be used, which will be selected by the patients' legal guardians. Group B corresponds to patients who will be exposed to pre-recorded music, of the genre of lullabies, instrumental type, using a speaker that will be placed inside the patient's incubator. Group C will be those patients in whom no musical intervention will be performed.
| Arm | Type | Receives |
|---|---|---|
| Live music | Experimental | Other: Music therapyIt is performed by a music therapist using the guitar as the only musical instrument. Instrumental lullabies are used, selected by the patient's legal guardian. |
| Pre-recorded music | Experimental | Other: Music therapyPre-recorded music of the lullaby genre, instrumental type, using a speaker placed inside the patient's incubator. |
| Control | No intervention | –There will be no musical intervention. |
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns with gestational age at birth greater than or equal to 32 weeks.
- Birth weight greater than or equal to 1500 grams.
- Be at least 72 hours of postnatal age.
Key exclusion criteria (9 listed)
- Respiratory disturbances in the last 48 hours such as: Apnea or Brief Resolved Unexplained Events (BRUE), need for invasive mechanical ventilation
- Hemodynamic alterations in the last 48 hours such as: Hypotension (systolic, diastolic, or mean BP < P5) or hypertension (systolic, diastolic, or mean BP > P95), bradycardia (HR < 100/min), shock of any etiology, requirement for volume expanders, infusion of inotropics, vasodilators and/or prostaglandin E1.
- Neurological alterations such as: Perinatal asphyxia at birth manifested by the need for resuscitation, APGAR < 3 at 5 minutes and/or ≤ 5 at 10 minutes, and metabolic acidosis in cord gases with a potential of hydrogen (pH) < 7 and base excess (BE) < -12, hypoxic-ischemic encephalopathy, seizure syndrome for up to 48 hours after the last clinical event or alteration of the brain pattern, interventricular hemorrhage in preterm infants in the first week of diagnosis.
- Management with Extracorporeal membrane oxygenation (ECMO) and/or nitric oxide
- Temperature less than 36.5 C or greater than 37.5 C.
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 |
|---|---|---|
| Music therapyMusic therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded instrumental lullabies music.The volume control will be conducted within the groups through the use of a decibel regulator, with a maximum volume of 70 dB. During the intervention and for a period of 30 minutes following its conclusion, singing will be prohibited by the music therapist or the parents. Both live and pre-recorded music will be instrumental in nature, lacking any lyrics. | Other | Live music, Pre-recorded music |
Primary outcome
Heart rate
Time frame: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
The measurement will be continuously quantified in terms of number of pulsations per minute continuously.
2 secondary outcomes
Respiratory rate
Time frame: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
Oxygen saturation
Time frame: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
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 19 Sep 2024.
- Individual participant dataSharing planned: No. When the study ends, individual participant data could be shared with the approval of the research ethics committee.
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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.
Johana Benavides, MSc study director
Unisanitas
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 therapy in people with Neonatal Disease, run by Claudia Aristizábal at 1 site in Colombia.
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 9 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 19 Sep 2024. 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 Colombia. 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?
Heart rate (time frame: The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.). 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 19 Sep 2024.