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Music Therapy With Intubated and Sedated Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03629145
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hannah Ivey, Children's Healthcare of Atlanta

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Behavioral: Live Music Therapy Behavioral: Recorded Music Therapy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated
Actual Study Start Date : January 16, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Live Music Therapy
Twenty minutes of live, preferred music played on guitar and voice
 Behavioral: Live Music Therapy
Investigator will begin play live guitar and voice music.
Placebo Comparator: Recorded Music
Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator
 Behavioral: Recorded Music Therapy
Investigator will play recorded music.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate [ Time Frame: up to sixty minutes post intervention. ]
    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.

  2. Respiratory Rate [ Time Frame: up to sixty minutes post intervention. ]
    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.

  3. Blood Pressure [ Time Frame: up to sixty minutes post intervention. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629145


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Healthcare of Atlanta
  Study Documents (Full-Text)

Documents provided by Hannah Ivey, Children's Healthcare of Atlanta:
Study Protocol and Statistical Analysis Plan  [PDF] November 20, 2017
Informed Consent Form  [PDF] January 11, 2018

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Hannah Ivey, Music Therapist, Board-Certified, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT03629145    
Other Study ID Numbers: MUSIC02
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections