Clinical trial NCT02845947: Music Therapy During Pediatric Extubation Readiness Trials
Official title: Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 17
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.
timeFrame: Through study completion, an average of 1 year.
measure: Music Therapy will aid in the success of extubation readiness trials as measured by sedation bolus requirements.
timeFrame: Through study completion, an average of 1 year.
measure: Music Therapy will aid in the success of extubation readiness trials as measured by agitation levels.
timeFrame: Through study completion, an average of 1 year.
measure: Music Therapy will reduce anxiety of physicians and nurses during the extubation readiness trial.
timeFrame: Through study completion, an average of 1 year.
measure: Music Therapy will reduce anxiety of parents/guardiansduring the extubation readiness trial.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
Study officials:
affiliation: Northwell Health
name: Shawna N Vernisie, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensivist
name: James B Schneider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Mary Schafer, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Peter Silver, MD
role: PRINCIPAL_INVESTIGATOR
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