The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated
Phase: NA
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Children's Healthcare of Atlanta

 
 
 
 
 
The Effect of Live Music Therapy Interventions with Pediatric Patients who are Mechanically 
Ventilated and Sedated 
 
November 20th, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol and Statistical Analysis  
The music therapist will introduce self to the patient’s caregiver at bedside to discuss 
study.  After obtaining consent, the caregiver-patient dyad will be assigned to either the live 
music therapy group or control group in an block randomization.  Caregivers in both groups will 
be asked to complete the Parental Beliefs Scale for Hospitalized Children (PBS) prior to the 
intervention and baseline child measures (HR, MAP, RR) will be collected.  Both interventions 
will be provided at bedside and post intervention child measures will be collected immediately 
following the intervention.  The participants will be thanked for participation in the study and 
provided with a CD as well as ways to incorporate music at home to support development for 
their participation in the study.  Child measures will also be collected 30 minutes and 60 minutes 
post intervention for both groups in their electronic medical record.  Caregivers will be asked to 
complete the PBS 60 minutes following the intervention.   
Both interventions will be conducted in the child’s primary language (English or 
Spanish).  Spanish songs were identified by hospital employed medical interpreters.  The control 
group CD will be recorded by the principal investigator utilizing guitar and voice with the exact 
songs utilized in the live music therapy intervention.  The recording will be completed at a music 
studio in Atlanta to assure a high quality recording for the control group.   
Data Analysis Procedures 
Patients will be measured at 4 time points: prior to intervention, immediately post 
intervention, and 30 minutes and 60 minutes later.  Because each subject is measured multiple 
times,the data will be analyzed using a repeated measures analysis of variance model.  Each 
condition will be compared to baseline to determine the relative effectiveness and sustainability 
of the intervention (i.e., effect at 1 hour). Changes in parental efficacy will be determined using 

paired t-tests of Wilcoxon signed rank tests.  Data will be described using means and standard 
deviations, counts and percentages or medians and ranges, as appropriate. Difference in means 
between time points will be further quantified using 95% confidence intervals. Analysis will be 
conducted using SAS v. 9.4 and statistical significance will be assessed at the 0.05 level.  Given 
the sample size of 24, there is sufficient power (>80%) to detect at least a 5 point decrease in HR 
and MAP from baseline.