Music Therapy for Patients Being Weaned From Mechanical Ventilation
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Music Therapy, Mechanical ventilation, Weaning from mechanical ventilation, complementary and alternative therapy
Eligibility Criteria
Inclusion Criteria: Anxiety weaning sessions less than 8 hours Exclusion Criteria: weaning trials greater than 8 hours -
Sites / Locations
- University of Rochester
Outcomes
Primary Outcome Measures
Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects.
Secondary Outcome Measures
Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures
- decreased use of anxiolytic, antidepressant and antipsychotic agents.
Full Information
NCT ID
NCT00178139
First Posted
September 12, 2005
Last Updated
August 26, 2015
Sponsor
University of Rochester
Collaborators
Arthur Flager Fultz Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00178139
Brief Title
Music Therapy for Patients Being Weaned From Mechanical Ventilation
Official Title
Music Therapy as an Adjunctive Treatment in the Management of Stress for Patients Being Weaned From Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
Collaborators
Arthur Flager Fultz Research Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Music Therapy, Mechanical ventilation, Weaning from mechanical ventilation, complementary and alternative therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
Music Therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures
Time Frame
prospective
Title
- decreased use of anxiolytic, antidepressant and antipsychotic agents.
Time Frame
prospective
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anxiety
weaning sessions less than 8 hours
Exclusion Criteria:
weaning trials greater than 8 hours
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olle Jane Z Sahler, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
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Music Therapy for Patients Being Weaned From Mechanical Ventilation
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