Music Therapy With Intubated and Sedated Pediatric Patients

Study Overview
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Brief Summary
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The study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. The experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. Caregivers will take a pre and post survey.

Detailed Description
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Data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. Caregivers will take the Parental Belief Scale for Hospitalized Children prior to intervention and 60 minutes poster intervention.

Official Title
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The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Behavioral: Live Music Therapy
* Behavioral: Recorded Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu mechanically ventilated sedated Patients with underlying diagnosis accepted unless listed below Patients must have a primary caregiver present Exclusion Criteria: Patients who are oscillating have a previous diagnosis of severe or profoundly deaf have a suspicion of child abuse in custody of the state.

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live Music Therapy<br>Twenty minutes of live, preferred music played on guitar and voice | Behavioral: Live Music Therapy<br>* Investigator will begin play live guitar and voice music.<br>|
| Placebo Comparator: Recorded Music<br>Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator | Behavioral: Recorded Music Therapy<br>* Investigator will play recorded music.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Describe the effect of a live music therapy intervention on HR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU. | up to sixty minutes post intervention. | 
| Respiratory Rate | Describe the effect of a live music therapy intervention on RR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU. | up to sixty minutes post intervention. | 
| Blood Pressure | Describe the effect of a live music therapy intervention on BP in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU. | up to sixty minutes post intervention. |