Music Therapy With Intubated and Sedated Pediatric Patients

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629145
• Other study ID #: MUSIC02
• Status: Completed
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Behavioral:
• Live Music Therapy
Investigator will begin play live guitar and voice music.
• Recorded Music Therapy
Investigator will play recorded music.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

References & Publications (3)

Austin D. The psychophysiological effects of music therapy in intensive care units. Paediatr Nurs. 2010 Apr;22(3):14-20. Review. — View Citation

Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010 Apr;19(7-8):978-87. doi: 10.1111 — View Citation

Hetland B, Lindquist R, Chlan LL. The influence of music during mechanical ventilation and weaning from mechanical ventilation: A review. Heart Lung. 2015 Sep-Oct;44(5):416-25. doi: 10.1016/j.hrtlng.2015.06.010. Epub 2015 Jul 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.