MTPERT: Music Therapy During Pediatric Extubation Readiness Trials

Sponsor
Northwell Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02845947
Collaborator
(none)
140
1
2
71
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music Therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study
Actual Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures. [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.

  2. Music Therapy will aid in the success of extubation readiness trials as measured by sedation bolus requirements. [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.

  3. Music Therapy will aid in the success of extubation readiness trials as measured by agitation levels. [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.

  4. Music Therapy will reduce anxiety of physicians and nurses during the extubation readiness trial. [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.

  5. Music Therapy will reduce anxiety of parents/guardiansduring the extubation readiness trial. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cohen Children's Medical Center New Hyde Park New York United States 11040

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shawna N. Vernisie, Licensed Creative Arts Therapist - Music Therapist, Northwell Health
ClinicalTrials.gov Identifier:
NCT02845947
Other Study ID Numbers:
  • HS16-0478
First Posted:
Jul 27, 2016
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2021