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临床试验/NCT02845947
NCT02845947已完成不适用

Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study

Northwell Health2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawna N. Vernisie

Licensed Creative Arts Therapist - Music Therapist

Northwell Health

研究点 (2)

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