Back to resultsImpact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy
Primary Purpose
Anxiety and Distress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
music therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety and Distress
Eligibility 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.
Sites / Locations
- Beth Israel Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
music therapy
control
Arm Description
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.
no intervention
Outcomes
Primary Outcome Measures
Reduction in state anxiety
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
reduced distress
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02150395
Brief Title
Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy
Official Title
The Impact of Music Therapy on Anxiety in Patients Newly Diagnosed With Cancer & Undergoing Simulation for Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
music therapy
Primary Outcome Measure Information:
Title
Reduction in state anxiety
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
reduced distress
Description
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.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne V Loewy, DA
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy
We'll reach out to this number within 24 hrs