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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00178139
Other study ID # 10243
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated August 26, 2015
Start date April 2004
Est. completion date July 2006

Study information

Verified date August 2015
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Anxiety

- weaning sessions less than 8 hours

Exclusion Criteria:

weaning trials greater than 8 hours

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Music Therapy
Music Therapy

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Arthur Flager Fultz Research Fund

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Thera

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects. prospective No
Secondary Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures prospective No
Secondary - decreased use of anxiolytic, antidepressant and antipsychotic agents. prospective No
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