Music Therapy During Pediatric Extubation Readiness Trials (MTPERT)
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Insufficiency
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.
Sites / Locations
- Cohen Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music Therapy
Control
Arm Description
Music Therapy to be provided for pediatric patients undergoing extubation readiness trial
Patients undergoing standard extubation readiness trial
Outcomes
Primary Outcome Measures
Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.
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 sedation bolus requirements.
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 aid in the success of extubation readiness trials as measured by agitation levels.
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 physicians and nurses during the extubation readiness trial.
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.
Music Therapy will reduce anxiety of parents/guardiansduring the extubation readiness trial.
A survey (authored by the PI's) will be provided to parents/guardians rating their anxiety score based on a 5-point Likert scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02845947
Brief Title
Music Therapy During Pediatric Extubation Readiness Trials
Acronym
MTPERT
Official Title
Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2023 (Actual)
Study Completion Date
June 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
Music Therapy to be provided for pediatric patients undergoing extubation readiness trial
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients undergoing standard extubation readiness trial
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention 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 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.
Primary Outcome Measure Information:
Title
Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Music Therapy will aid in the success of extubation readiness trials as measured by sedation bolus requirements.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Music Therapy will aid in the success of extubation readiness trials as measured by agitation levels.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Music Therapy will reduce anxiety of physicians and nurses during the extubation readiness trial.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Music Therapy will reduce anxiety of parents/guardiansduring the extubation readiness trial.
Description
A survey (authored by the PI's) will be provided to parents/guardians rating their anxiety score based on a 5-point Likert scale.
Time Frame
Through study completion, an average of 1 year.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawna N Vernisie, MA
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James B Schneider, MD
Organizational Affiliation
Intensivist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Schafer, BSN
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Silver, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Citation
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Music Therapy During Pediatric Extubation Readiness Trials
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