Skip to main content
OpenTrials
Completed

NCT Number: NCT03629145

Music Therapy With Intubated and Sedated Pediatric Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Live Music Therapy

Behavioral

Investigator will begin play live guitar and voice music.

Recorded Music Therapy

Behavioral

Investigator will play recorded music.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.