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Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02150395
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Description
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Brief Summary:
This study looks at the effects of a protocolized music therapy intervention on state anxiety for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an imaging and diagnostic procedure, has been identified as producing significantly high levels of anxiety in many cancer patients.

Condition or disease Intervention/treatment Phase
Anxiety and Distress Other: music therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Music Therapy on Anxiety in Patients Newly Diagnosed With Cancer & Undergoing Simulation for Radiation Therapy
Study Start Date : July 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: music therapy
pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.
 Other: music therapy
No Intervention: control
no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in state anxiety [ Time Frame: 20 minutes ]
    pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.


Secondary Outcome Measures :
  1. reduced distress [ Time Frame: 20 minutes ]
    pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed patients with breast cancer, and newly diagnosed patients with head and neck cancer.
  • 18 or over.
  • Fluent in English.

Exclusion Criteria:

  • Under 18 years.
  • Pre-existing anxiety disorders.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150395


Locations
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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
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Principal Investigator: Joanne V Loewy, DA Beth Israel Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02150395    
Other Study ID Numbers: IRB 199-13
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders