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Clinical Trials/NCT02845947
NCT02845947
Completed
Not Applicable

Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study

Northwell Health1 site in 1 country17 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
Northwell Health
Enrollment
17
Locations
1
Primary Endpoint
Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
June 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shawna N. Vernisie

Licensed Creative Arts Therapist - Music Therapist

Northwell Health

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Study Sites (1)

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