Music Therapy for Patients Being Weaned From Mechanical Ventilation - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 11, 2008

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects.

Change History

Complete list of historical versions of study NCT00178139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures
- decreased use of anxiolytic, antidepressant and antipsychotic agents.

Descriptive Information

Brief Title ^ICMJE

Music Therapy for Patients Being Weaned From Mechanical Ventilation

Official Title ^ICMJE

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

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.

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Respiratory Insufficiency

Intervention ^ICMJE

Behavioral: Music Therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Anxiety
weaning sessions less than 8 hours

Exclusion Criteria:

weaning trials greater than 8 hours

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Olle Jane Z Sahler, MD

585-275-3882

OJ_Sahler@urmc.rochester.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00178139

Responsible Party

Bryan Hunter, PhD, Nazareth College

Study ID Numbers ^ICMJE

10243

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Arthur Flager Fultz Research Fund

Investigators ^ICMJE

Principal Investigator:

Olle Jane Z Sahler, MD

University of Rochester

Information Provided By

University of Rochester

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP