Music Therapy During Pediatric Extubation Readiness Trials (MTPERT)

September 11, 2023 updated by: Shawna N. Vernisie, Northwell Health

Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study

This study seeks to research the effects of music therapy during pediatric extubation readiness trials. Amount of sedation, physiological measures, and parent/staff satisfaction surveys will be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The music therapy intervention offered during the time of the patient's extubation readiness trial (ERT) will consist of live music using a multitude of instruments and patient-preferred and improvised music. The start time and duration of the session will be initiated by the attending physician, and the length of music therapy intervention provided will not exceed two and a half hours. The music therapy intervention will continue for 30 minutes post extubation. This time frame was determined in accordance with the institution's weaning trial protocol. Family members involved in the trial, as well as the nurse and physician, will complete a post-procedural survey about the music therapy intervention.

The music therapy interventions will always include the use of live music, including guitar, keyboard, voice, ocean drum, reverie harp, and/or various percussive instruments. The music therapist will use a tablet to understand how to play patient-preferred songs. To ensure patient safety, the music therapist will adhere to the infection control policies set forth by the institution. The following are the intended goals of the Music therapy intervention: facilitating relaxation, alleviation of anxiety, and successful utilization of new coping skills.

Before the weaning trial, the music therapist will meet with the patient's family to obtain the musical preferences of the patient. During the two hour ERT, the music therapist will play patient-preferred songs on a variety of different instruments to bring about a sense of interpersonal connectedness, normalization, and to enhance adaptive coping. In order to maximize coping and minimize stress/anxiety, the music therapy intervention will be malleable and patient/family centered, responding to the changing needs that present throughout the procedure/weaning process. If the patient becomes more alert throughout the weaning process, the music therapist will adapt the music making based on patient's preferences; at this time, the patient may be able to answer yes/no questions when asked. The music therapist will adjust the volume, timbre, and tempo of the music according to the patient's respiratory rhythms throughout the weaning process and after extubation.

When the live music therapy intervention has completed, the music therapist will follow up with the family members immediately. The investigator will administer and collect the survey from the family, and the music therapist will administer and collect the survey from the nurse and physician.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Cohen Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 0-18 years of age admitted to the pediatric intensive care unit, regardless of cognitive status
  • Patients admitted receiving endotracheal mechanical ventilation

Exclusion Criteria:

  • Patients receiving extubation for withdrawal of care, patients with known/documented hearing loss/deafness.
  • Patients on mechanical ventilation not scheduled for planned ERT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy
Music Therapy to be provided for pediatric patients undergoing extubation readiness trial
Behavioral: Music Therapy
The music therapy intervention offered during the time of the patient's extubation readiness trial (ERT) will consist of live music using a multitude of instruments and patient-preferred and improvised music. The music therapy interventions will always include the use of live music, including guitar, keyboard, voice, ocean drum, reverie harp, and/or various percussive instruments. The music therapist will use a tablet to understand how to play patient-preferred songs. To ensure patient safety, the music therapist will adhere to the infection control policies set forth by the institution. The following are the intended goals of the Music therapy intervention: facilitating relaxation, alleviation of anxiety, and successful utilization of new coping skills.
No Intervention: Control
Patients undergoing standard extubation readiness trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.
Time Frame: Through study completion, an average of 1 year.
A data collection tool (created by the PI's) will be used to record physiological signs (heart rate and blood pressure) by a Registered Nurse (RN) every 15 minutes. The heart rate will be captured from an Intensive Care Unit monitor and the blood pressure will be measured by a blood pressure cuff administered by a RN.
Through study completion, an average of 1 year.
Music Therapy will aid in the success of extubation readiness trials as measured by sedation bolus requirements.
Time Frame: Through study completion, an average of 1 year.
A data collection tool (created by the PI's) will be used to record sedation bolus requirements (mcg/kg) every 15 minutes throughout the length of the extubation readiness trial. This will be administered and recorded by an RN.
Through study completion, an average of 1 year.
Music Therapy will aid in the success of extubation readiness trials as measured by agitation levels.
Time Frame: Through study completion, an average of 1 year.
A data collection tool (created by the PI's) will be used to record agitation levels (using the State Behavioral Scale for Mechanically Ventilated Patients) every 15 minutes throughout the length of the extubation readiness trial.
Through study completion, an average of 1 year.
Music Therapy will reduce anxiety of physicians and nurses during the extubation readiness trial.
Time Frame: Through study completion, an average of 1 year.
A survey (authored by the PI's) will be provided to physicians and nurses rating their anxiety score based on a 5-point Likert scale.
Through study completion, an average of 1 year.
Music Therapy will reduce anxiety of parents/guardiansduring the extubation readiness trial.
Time Frame: Through study completion, an average of 1 year.
A survey (authored by the PI's) will be provided to parents/guardians rating their anxiety score based on a 5-point Likert scale.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Shawna N Vernisie, MA, Northwell Health
  • Principal Investigator: James B Schneider, MD, Intensivist
  • Principal Investigator: Mary Schafer, BSN, Northwell Health
  • Principal Investigator: Peter Silver, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 23, 2016

First Posted (Estimated)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS16-0478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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