The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate
Phase: NA
Conditions: Neonatal Disease
Sponsor: Claudia Aristizábal

                                                      
 
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The Effect of Music Therapy as an Adjuvant in Stabilizing the Vital 
Signs of the Neonate: A Randomized Controlled Clinical Trial 
Protocol 
 
 
 
 
 
 
 
 
 
 
 
April 30th, 2024 
 
 
 
 
 

                                                      
 
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Background 
Partial fetal hearing maturity is reached between 24 and 27 weeks of gestational age. At 
this stage of fetal development, the fetus is able to perceive the acoustic parameters of 
speech, such as melody, rhythm, prosody, phonemes, and different tones (1). It is also able 
to hear the sounds produced by the placenta, adjacent organs, and the maternal 
heartbeat, which are rhythmic, low in volume, and low in frequency. The fetus is in a 
protective environment because, in addition, the amniotic fluid and the tissues of the 
adjacent maternal organs act as filters for high-frequency external sounds (1,2). 
However, exposure of a newborn to the extrauterine environment, and especially those 
who require hospitalization in a neonatal intensive care unit (NICU), involves a series of 
events that affect not only the newborn, but also their parents and/or caregivers (3). In 
addition, the reasons for hospitalization include a long hospital stay, which increases the 
exposure of patients and caregivers to stressful situations. For example, neonates are 
constantly exposed to unfamiliar stimuli such as sounds from infusion monitors and 
pumps (auditory), lights (visual), and contact with external elements, as well as painful 
procedures such as intubation and venipuncture (tactile) (1,3,4). 
As a result, during hospitalization, neonates are immersed in an adverse environment 
compared to the intrauterine environment, which triggers a physiological response to 
stress that increases oxygen consumption and caloric expenditure during development 
(5). In addition, the multiple procedures to which they are subjected generate greater 
stress, which translates into alterations in the sleep-wake cycle and anxiety. The latter may 
be manifested by the activation of the sympathetic nervous system, causing an increase 
in the variability of vital signs such as heart rate, respiratory rate, and blood pressure (5). 
In preterm infants, these effects are even more pronounced. Prematurity itself is 
associated with an increased risk of complications and, in addition to overstimulation, 
leads to adverse effects on growth and neurodevelopment, including changes in brain 
structure and function (2). The sounds present in NICUs, which are unpredictable and have 
frequencies reaching peaks of 120 decibels, result in short-term adverse effects on the 
cardiovascular and respiratory systems (6). For example, an increased susceptibility to 
episodes of apnea and hypoxemia has been described (2,6). 
Similarly, caregivers are also exposed to environmental stressors, and observing invasive 
and noninvasive procedures performed on their children and other patients increases this 
exposure. An example of these stressors is the early separation of the binomial and the 
perception of not being able to fully care for the newborn, which leads to a lack of 
autonomy in the role of primary caregiver of the newborn (4). So much so that such an 

                                                      
 
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event can increase the risk of depression and anxiety disorders. It has even been found 
that the postpartum stress experienced by mothers during the hospital stay is negatively 
associated with nutrition, growth and development, and the success of attachment of the 
binomial (3). 
One of the most popular strategies in recent years is music therapy. This is defined as the 
clinical use of music as a therapeutic intervention to achieve individualized goals in 
patients (7). It is an evidence-based, non-pharmacological, non-invasive, dynamic, safe, 
enjoyable, and cost-effective strategy (1-9). In addition, it is a measure that promotes 
socio-cultural activities in health care institutions and reduces financial costs due to its 
ability to minimize pharmacological or invasive interventions to promote the well-being 
of the newborn.   
Studies, including randomized clinical trials, systematic reviews, and meta-analyses, have 
shown beneficial effects on length of hospital stay, neurodevelopment, and normalization 
of vital signs (1,3,7,10-13). It has also been shown to be effective in reducing anxiety in 
mothers of hospitalized neonates (1-3,5,6,12,13,14,16). However, there is heterogeneity 
in the selection of variables studied and small population samples. In addition, it is 
necessary to know if there is a significant difference between the use of live music therapy 
and pre-recorded music that affects neonates, which is why the present study is necessary. 
In addition, this study will allow us to evaluate how music therapy is a non-invasive 
complementary strategy for the stabilization of physiological variables of newborns. 
Research question  
¿What is the effect of an intervention such as music therapy, through an electronic device 
and live, on vital variables in newborns over 32 weeks hospitalized in the Neonatal 
Intensive Care Unit of the Clinica Universitaria Colombia? 
 
1.1. Proyect rationale 
Prematurity is a public health problem, requiring special high-risk perinatal care provided 
by trained professionals, which implies a high socioeconomic cost (1). About 15 million 
children are born preterm each year, corresponding to a rate of more than 1 preterm birth 
for every 10 live births. This pathology is on the rise and is directly linked to a higher 
presence of morbidity and mortality and associated complications, and therefore to a 
higher rate of hospitalizations in NICUs (12,15). Thanks to advances in health systems, the 
survival rate has improved. However, the short-, medium- and long-term effects linked to 
prematurity, such as neurodevelopment, are still present (4,14). 

                                                      
 
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Multiple efforts have been made to identify and develop strategies to counteract the 
negative effects of the environment in NICUs and improve the well-being of the pair. This 
is where the concepts of Developmental Care and Family-Centered Neonatal Care arise, 
both examples of the methods used to promote the humanization of health services. The 
first is defined as the use of medical and basic care interventions, in order to reduce the 
stress of neonates in NICUs (8). This consists of restructuring the environment, modifying 
elements such as the intensity of the lights and the reduction of sounds. It also includes 
improved neonatal posture, decreased body manipulation, and pain management. The 
second is an approach that promotes parental involvement in caring for the child's 
emotional, social, and developmental needs. In the latter, communication between the 
family and health personnel is encouraged, as well as the improvement of elements in the 
environment such as individualized spaces and the attitude of NICU professionals (9). 
One of these strategies is music therapy, a health profession dedicated to humanized care 
based on the use of both live and recorded music, in order to positively impact health in 
the field of neonatology and the well-being of caregivers(12,16). This study will allow us 
to evaluate how music therapy is a non-invasive complementary strategy for the 
stabilization of the physiological variables of newborns. This then implies a possible 
reformulation of institutional and public health policies, promoting the realization of 
socio-cultural activities in the different organizations of the Keralty group. 
Primary Objective:  
To determine the effect of live and pre-recorded music therapy on vital variables in 
newborns older than 32 weeks hospitalized in the Neonatal Intensive Care Unit of the 
Clinica Universitaria Colombia (CUC). 
Secondary objectives  
• To describe the demographic and clinical characteristics of study participants. 
• To analyze the effect of live and pre-recorded music therapy on the vital signs (heart 
rate, respiratory rate, and oxygen saturation) of study participants. 
• To categorize the stressful events, present in neonatal intensive care units according 
to their origin, namely auditory, tactile, and visual. 
Methodology 
Study Design 
 

                                                      
 
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A prospective analytical, pragmatic clinical trial-type study will be conducted to provide 
evidence on the benefits of health interventions in real-world settings (in routine clinical 
practice). The study will be conducted at the Neonatal Intensive Care Unit of the CUC in 
Bogotá D.C. during the period from May 1st to June 30th, 2024. 
Study Population 
The study will include newborns who are older than 32 weeks gestational age at birth 
and who are hospitalized in the Neonatal Intensive Care Unit of the CUC. 
 
Inclusion criteria  
All newborns who meet the following inclusion criteria will be included: 
- 
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. 
 
Exclusion criteria 
All newborns who meet at least one of the following criteria will be excluded:   
- 
Respiratory disturbances in the last 48 hours such as:  
o Apnea or Brief Resolved Unexplained Events (BRUE). 
o Need for invasive mechanical ventilation.  
- 
Hemodynamic alterations in the last 48 hours such as:   
o Hypotension (systolic, diastolic, or mean BP < P5) or hypertension 
(systolic, diastolic, or mean BP > P95). 
o Bradycardia (HR < 100/min). 
o Shock of any etiology 
o Requirement for volume expanders, infusion of inotropic, vasodilators 
and/or prostaglandin E1 
- 
Neurological alterations such as:  
o 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 pH < 7 and BE < -12. 
o Hypoxic-ischemic encephalopathy. 
o Seizure syndrome for up to 48 hours after the last clinical event or 
alteration of the brain pattern. 
o 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. 
Sample size  
The sample size was determined using the G*Power 3.1.9.7 program, with a 
confidence level of 95%, statistical power of 90%, mean difference in heart rate 
between the live music therapy group (140 bpm), prerecorded music therapy group 
(127 bpm), and the control group (147 bpm). A total sample size of 45 was calculated, 
with a ratio of 1:1:1 between groups. This equates to 15 participants in each group. 
Sample Selection  
Stratified random sampling will be used, with two strata according to gestational age 
defined as follows: stratum 1 neonates <37 weeks and stratum 2 neonates ≥37 weeks. 
Blocked randomization (block of size 3) will be used for each stratum and for the 
allocation of participants to each of the intervention and control groups (1:1:1).  The 
allocation sequence will be generated by Microsoft Excel®.  
 
The random assignment will be concealed through the use of opaque envelopes, 
which will be sealed and numbered sequentially. These envelopes will be carried out 
by the operational coordinator of the project. The carbon paper inside the envelope 
will transfer the details of the random number and the group to which it will be 
assigned (A, B or C). This will ensure that the envelope is not permeable to intense 
light. The envelopes will be sealed with tamper-evident security tape and will be 
opened sequentially only after the participant, meeting the eligibility criteria, has 
received the envelope. The envelopes will be kept in a folder that will be kept on a 
locked shelf within each unit, which will be in the custody of the project's operational 
coordinator. 
 
Blinding 
It is not possible to blind the participants or the music therapist from randomization 
due to the nature of the intervention. 
 
 
Variable Matrix 
Variable name 
Operational Definition 
Nature and Scale of 
Measurement. 
Unit of 
measurement 
Date of birth 
Time in which he was born. 
Quantitative – 
Discrete 
Day/Month/Year 

                                                      
 
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Sex 
Biological characteristics that 
determine whether it is female 
or male. 
Qualitative – 
Nominal – 
Dichotomous 
1: Female 
2: Male 
Gestational age at 
birth 
Number of weeks gestation at 
the time of birth. 
Quantitative – 
Continuous  
Weeks and days of 
gestational age 
Postnatal age at 
study entry 
Age in hours or days since birth. Quantitative – 
Discrete  
Hours or days 
Birth weight 
Weight determined by a 
calibrated neonatal scale. 
Quantitative – 
Continuous 
Grams 
Classification 
according to birth 
weight 
Birth weight classification. 
Qualitative – 
Nominal – Polytomic  
1: Extreme low 
birth weight 
newborn (< 1000 
grams) 
2: Very low birth 
weight newborn (< 
1500 grams) 
3: Low birth 
weight newborn (< 
2500 grams) 
Birth Weight 
Percentile 
Relationship between age, 
height, head circumference and 
weight.  
Quantitative – 
Discrete 
Percentile Value 
Clustered Birth 
Weight Percentile 
Comparison of the weight of the 
newborn with the rest of the 
same age and sex. 
Quantitative – 
Discrete 
1: Birth weight 
below the 10th 
percentile 
2: Birth weight 
between the 10th 
and 90th 
percentile 
3: Birth weight 
above the 90th 
percentile 
Weight-for-
gestational-age 
classification 
Classification of weight in 
relation to gestational age at 
birth. 
Qualitative – Ordinal 
– Polytomic  
1: Small for 
gestational age 
2: Suitable for 
gestational age 
3: Great for 
Gestational Age 
APGAR Score 
A clinical visual examination 
performed on the newborn one 
minute and 5 minutes after 
birth to assess physiological 
adaptation to the extrauterine 
environment. 
Quantitative – 
Discrete  
Score from 0 to 10  

                                                      
 
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APGAR Rating 
Classification of neonatal 
adaptation to the extrauterine 
environment, given by the score 
in the APGAR criteria. 
Qualitative – 
Nominal – Polytomic  
1: Normal (7-10 
points) 
2: Moderate 
depression (4-6 
points) 
3: Severe 
depression (0-3 
points) 
Presence of 
comorbidities in the 
neonate 
Presence or absence of 
associated diseases. 
Qualitative – 
Nominal – 
Dichotomous 
1: Yes 
2: No 
Name of the 
associated 
pathology 
The medical term referring to 
the disease that the individual 
presents.  
Qualitative – 
Nominal  
Name of the 
disease 
Perinatal history 
Presence of important events 
during pregnancy. 
Qualitative – 
Nominal  
Background Name 
Number of visits  
Number of Parent Visits During 
the Day 
Quantitative - 
discrete 
Number  
Singing 
Emission of sounds or musical 
compositions by parents or legal 
guardian up to 30 minutes prior 
to the intervention.  
Qualitative – 
Nominal – 
Dichotomous  
1: Yes 
2: No 
Heart rate 
Number of heartbeats 
measured at minute 0, from 
minute 0 to 30 minutes after 
the procedure continuously and 
30 minutes after the 
intervention. 
Quantitative – 
Discrete  
Beats per minute 
(bpm) 
Respiratory rate 
Number of breaths measured at 
minute 0, from minute 0 to 30 
minutes after the intervention 
continuously and at 30 minutes 
after the intervention. 
Quantitative – 
Discrete 
Breaths Per 
Minute (rpm) 
Oxygen saturation 
Measurement of the 
percentage of oxygen 
availability in the blood, 
measured at minute 0, from 
minute 0 to 30 minutes after 
the intervention continuously 
and at 30 minutes after the 
intervention. 
Quantitative – 
Discrete 
Percentage of 
SaO2 (SaO2%) 

                                                      
 
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Description of interventions 
Music therapy is a non-pharmacological therapeutic intervention that will be 
implemented through two modalities: live and pre-recorded music. Group A will be 
comprised of patients who have been 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.  
 
The patient will be placed in an incubator, monitored with a vital sign monitor and 
pulse oximetry, and under the supervision of a research assistant. The research 
assistant will be responsible for recording the variables at minute 0, from minute 0 
to minute 10, and 30 minutes after the completion of music therapy or non-
intervention. The volume will be controlled in the three groups by means 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, in the case of groups A and B, by 
the parents. This prohibition will be implemented in the same manner in group C, 
which will be devoid of any form of music exposure in order to prevent the 
introduction of confounding variables. Both live and pre-recorded music will be 
instrumental in nature, lacking any lyrics. In accordance with the protocol for 
admission to the neonatal unit, the use of electronic devices is restricted. 
Consequently, patients will not be exposed to auditory stimuli of this nature. 
Sources of information 
The source of information will be primary. Demographic and clinical data will be 
obtained from the medical record.  The vital signs data such as heart rate, respiratory 
rate and oxygen saturation will be obtained from the records of the monitors of the 
intensive care units, at the established times, which are: at minute 0, from minute 0 
to minute 10 continuously and at 30 minutes after the intervention. 
Standardization of measurements 
For the standardization of measurements of the different physiological variables, 
several elements will be considered. First, the trademark of the medical equipment 
manufacturer of each of the tools that will be used (vital sign monitor and pulse 
oximeter) will be verified, verifying that they correspond to the same commercial 
brand since they are different brands, there may be variability between the standard 
calibration measurements considered within the critical range. Second, it will be 
verified that each medical tool used has been calibrated in the last 6 months, 
recording the date of last calibration so that the device can be used during the study. 

                                                      
 
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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 used during the implementation of the pre-recorded and live music, 
which will adjust the volume of the sound emitted. to ensure the same decibels per 
research subject, with a maximum allowable of 70 dB. Vital variables will be recorded 
at minute 0, from minute 0 to minute 10 and at 30 minutes after the intervention. 
 
Primary Outcome 
The primary outcome of this study is the heart rate (HR), which will be measured 
through pulse oximetry every minute, beginning at minute 0 (prior to the 
intervention), then from minute 0 to minute 30 (during the intervention), and finally 
at 30 minutes after the intervention. 
 
 
Secondary Outcomes 
• Respiratory rate (RR) will be measured through pulse oximetry every minute, 
beginning at minute 0 (prior to the intervention), then from minute 0 to 
minute 30 (during the intervention), and finally at 30 minutes after the 
intervention. 
• Oxygen saturation (SO) will be measured through pulse oximetry every 
minute, beginning at minute 0 (prior to the intervention), then from minute 0 
to minute 30 (during the intervention), and finally at 30 minutes after the 
intervention. 
Analysis of information 
A descriptive analysis of the variables will be performed using absolute and relative 
frequencies for the qualitative variables, as well as measures of central tendency and 
dispersion for the quantitative variables according to their normal distribution 
evaluated through the Kolmogorov-Smirnov test.  To compare the data between the 
groups, one-way ANOVA or Kruskal-Wallis and chi-square ANOVA will be used. To 
determine the effect of music therapy on vital signs, repeated measures ANOVA or 
the Friedman test, if applicable, will be used. Assumptions of normality, 
homoscedasticity and residual distribution will be evaluated. Post-hoc comparisons 
are performed to determine significant differences between groups using the Student 
t-test. The level of significance for statistical tests will be p=<0.05.  
A multivariate logistic regression will be performed to evaluate the effect of music 
therapy on respiratory rate, heart rate and pulse oximetry, considering confounding 
variables such as the number of visits, parental singing prior to the intervention, 
admission diagnosis, gestational age, comorbidities and gender. 

                                                      
 
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Ethical Considerations 
This research will adhere to the ethical guidelines developed by the CIOM and the 
WHO, as well as the stipulations of the Declaration of Helsinki for research involving 
human subjects. This will ensure the respect and protection of human rights, as well 
as the protection of the life, health, privacy, and dignity of the study subjects (24). 
Furthermore, this research is founded upon the tenets of bioethics, with the objective 
of promoting and ensuring justice, beneficence, non-maleficence, and patient 
autonomy, as outlined in the Belmont report from 1979 (25). Additionally, this 
research will have a social and scientific value, as its findings could potentially 
enhance the health of subjects and transform the manner in which care is delivered 
through the generation of reliable and valid results derived from a clinical trial. The 
researchers are highly qualified for the development of this research due to their 
expertise in pediatric and neonatal medicine, as well as epidemiology. For the 
administration of the interventions, a company with a high trajectory and experience 
in these interventions will be hired.  
 
In accordance with the provisions of Resolution 8430 of 1993 (26) of Colombia, as the 
population of this study is minors, who in this case are newborns who, due to their 
neurocognitive development, cannot exercise the principle of autonomy per se, this 
will be delegated to their guardian or legal representative through the completion of 
informed consent. The objectives and methodology of the research will be clearly 
explained to the legal representative of the neonate, including the type of music to 
be used, the daily duration of each session, the time of exposure, and the data to be 
collected. Conversely, the legally appointed representative will be permitted to 
observe the child's participation in the study as it progresses, provided that this does 
not result in any direct alteration of the results through manipulation or direct contact 
with the patient. This is to ensure that the principle of autonomy is not violated. 
Furthermore, the legal representative of the newborn will have the option to 
withdraw from the study at any time, without affecting the medical care of the 
newborn. This study is classified as a research study with a higher than minimum risk 
because the intervention can modify the physiological variables of the newborn. 
However, based on previous studies conducted nationally and internationally, it can 
be determined that the use of music therapy is at least as safe and advantageous, in 
light of the foreseeable risks and benefits, as any other established effective 
alternative.  
 
In order to guarantee the privacy and confidentiality of the information of the subjects 
involved in the study, the provisions of the Habeas Data Law (Law 1581 of 2012) and 
Resolution 1995 of 1999 will be taken into account. An alphanumeric code will be 
used to identify the study subjects. Only the researchers will have access to the 
databases, and the data will be safeguarded for up to one year after the publication 
of the results. No sensitive information will be disclosed in the publication or in other 

                                                      
 
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documents drafted during the investigation. The results of this research will only be 
used to provide new knowledge and encourage new studies.   
 
This research project will be presented to the research committee and the research 
ethics committee of the Fundación Universitaria Sanitas, where full compliance with 
ethical principles and quality standards will be taken into account for approval. 
Currently, there are no conflicts of interest declared by the principal investigator, the 
co-investigators, or the methodological advisor for the development of the research.   
 
 
 
 

                                                      
 
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