Medical Use of Song In Critical Care (MUSIC)

NCT01763736 | Terminated

• 1 other identifier: 2012-P-002287
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research study is to assess the effects of music on patients' experience in the Intensive Care Unit (ICU). The hypothesis of this study is that patients who receive music therapy will report a reduction in negative recollections and experiences while on mechanical ventilation and will require fewer pharmacologic agents to maintain their sedation.

Conditions

Stress; Anxiety; Sleep

Outcome Measures

Primary Outcomes (1)

• Response on ICU Stressful Experiences Questionnaire

  A 32-item, previously validated, ICU Stressful Experiences Questionnaire with the addition of a few questions specific to their recall and experience with the music while critically ill will be administered. Responses will be used to determined subject recall of the ICU and music intervention.

  After discharge from the ICU, while still in hospital (expected 5-10 days after hospital admission)

Secondary Outcomes (2)

• Change in vital signs

  Pre-music intervention and during music intervention

• Change in Vital Signs

  Before music intervention and after intervention

Study Arms (1)

Music

EXPERIMENTAL

Everyone enrolled with receive music sessions.

Behavioral: Music

Interventions

Music BEHAVIORAL

playlist per patient preference

Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥ 18 yrs of age
• Admitted to Medical Intensive Care Unit (MICU) (3B and 3C) or Surgical Intensive Care Unit (SICU) (8C, 8D, 11C)
• Expected to receive mechanical ventilation ≥ 24hr
• Surrogate present to provide informed consent

You may not qualify if:

• Intubated at a transferring hospital for \> 24 hr before arrival to Brigham and Women's Hospital (BWH)
• Chronically ventilator dependent before admission to the hospital
• Transplant candidate or recipient
• Non-English speaking as the questionnaire has not been translated
• Prisoner

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gerald Weinhouse, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 9, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)