Music Therapy for Patients Being Weaned From Mechanical Ventilation - Full Text View

Sponsor:	University of Rochester
Collaborator:	Arthur Flager Fultz Research Fund
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00178139

Purpose

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	Intervention	Phase
Respiratory Insufficiency	Behavioral: Music Therapy	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects. [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures [ Time Frame: prospective ] [ Designated as safety issue: No ]
- decreased use of anxiolytic, antidepressant and antipsychotic agents. [ Time Frame: prospective ] [ Designated as safety issue: No ]

Enrollment:	77
Study Start Date:	April 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Music Therapy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Anxiety
weaning sessions less than 8 hours

Exclusion Criteria:

weaning trials greater than 8 hours

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Bryan Hunter, PhD, Nazareth College
ClinicalTrials.gov Identifier:	NCT00178139 History of Changes
Other Study ID Numbers:	10243
Study First Received:	September 12, 2005
Last Updated:	August 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Music Therapy
Mechanical ventilation
Weaning from mechanical ventilation
complementary and alternative therapy

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2012