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

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 I

MedlinePlus related topics:

Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	Music Therapy as an Adjunctive Treatment in the Management of Stress for Patients Being Weaned From Mechanical Ventilation

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 ]

Estimated Enrollment:	40
Study Start Date:	April 2004

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

Contacts


Contact: Olle Jane Z Sahler, MD	585-275-3882	OJ_Sahler@urmc.rochester.edu

Locations


United States, New York
	University of Rochester	Recruiting
	Rochester, New York, United States, 14642
	Contact: D'Arcy J Gaisser, RN 585-275-3882 D'Arcy_Gaisser@urmc.rochester.edu
	Contact: RoseMary Oliva, MT-BC 585-273-2098 Rosemary_Oliva@urmc.rochester.edu
	Principal Investigator: Olle Jane Z. Sahler, MD

Sponsors and Collaborators

University of Rochester

Arthur Flager Fultz Research Fund

Investigators


Principal Investigator:	Olle Jane Z Sahler, MD	University of Rochester

More Information

Responsible Party:	Nazareth College ( Bryan Hunter, PhD )
Study ID Numbers:	10243
First Received:	September 12, 2005
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00178139
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

Study placed in the following topic categories:

Respiratory Insufficiency

Respiratory Tract Diseases

Respiration Disorders

Stress

ClinicalTrials.gov processed this record on September 04, 2008

Sponsors and Collaborators:	University of Rochester Arthur Flager Fultz Research Fund
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00178139