ClinicalTrials.gov
ClinicalTrials.gov Menu

Music Therapy for Patients Being Weaned From Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00178139
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Arthur Flager Fultz Research Fund
Information provided by (Responsible Party):
University of Rochester

Brief Summary:
The purpose of the study is to determine whether Music Therapy interventions can be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management.Music used is varied according to subject's preferences.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Behavioral: Music Therapy Phase 1

Detailed Description:
Music therapy interventions will be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management. The intervention will consist of 40 - 50 minutes of active music therapy and improvisation in which the music is used as a distraction from the hospital setting and the procedure taking place. The intervention will end with 5 to 10 minutes of discussion of music activities/selections to be used between music therapy sessions. The intervention is individualized and can be modified accordingly to the subject's preferences.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Music Therapy as an Adjunctive Treatment in the Management of Stress for Patients Being Weaned From Mechanical Ventilation
Study Start Date : April 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Intervention Details:
  • Behavioral: Music Therapy
    Music Therapy


Primary Outcome Measures :
  1. Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects. [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures [ Time Frame: prospective ]
  2. - decreased use of anxiolytic, antidepressant and antipsychotic agents. [ Time Frame: prospective ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anxiety
  • weaning sessions less than 8 hours

Exclusion Criteria:

weaning trials greater than 8 hours


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178139


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Arthur Flager Fultz Research Fund
Investigators
Principal Investigator: Olle Jane Z Sahler, MD University of Rochester

Publications of Results:
Oliva R, Hunter BC, Sahler OJZ, Gaisser D, Salipante DM. (2009). The Use of Music Therapy for Patients Being Weaned from Mechanical Ventilation: A Pilot Study. In Azoulay R & Loewy J (eds). Music, the Breath and Health: Advances in Integrative Music Therapy. New York: Satchnote Press.

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00178139     History of Changes
Other Study ID Numbers: 10243
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by University of Rochester:
Music Therapy
Mechanical ventilation
Weaning from mechanical ventilation
complementary and alternative therapy

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases