Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-12-31

Brief Summary

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The study is designed to analyze the use of music therapy to decrease pain and agitation in intubated ICU patients.

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Detailed Description

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This is a randomized, prospective single-blinded placebo-controlled study of consecutive intubated ICU patients requiring anxiolytics and analgesic medications. Patients will be randomized into two groups: one group will receive music (MUSIC), whereas the other group (CONTROL) will wear headphones, but hear an audio loop of recorded ICU sounds (vent alarms, ambient noise, talking, etc). The two groups will then be analyzed for sedation and analgesia requirements; Ramsay sedation score, ICP in brain injured patients, ventilator days, ICU length of stay, hospital length of stay, mean arterial blood pressure (MAP).

Conditions

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Music Therapy for Pain and Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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With Music

This randomized group will receive music

Group Type EXPERIMENTAL

provide headphones with music playing

Intervention Type OTHER

Participants will be provided with music through headphones

Control Arm

Will not receive music but will receive audio loop of recorded ICU sounds

Group Type PLACEBO_COMPARATOR

Sounds

Intervention Type OTHER

recorded ICU sounds will be provided to participants through headphones

Interventions

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provide headphones with music playing

Participants will be provided with music through headphones

Intervention Type OTHER

Sounds

recorded ICU sounds will be provided to participants through headphones

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics