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

Anxiety and Distress Clinical Trial

Official title:

The Impact of Music Therapy on Anxiety in Patients Newly Diagnosed With Cancer & Undergoing Simulation for Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150395
• Other study ID #: IRB 199-13
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: May 28, 2014
• Start date: July 2011
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety and Distress
• Anxiety Disorders

Intervention

Other:
• music therapy

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 minutes	No
Secondary	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.	20 minutes	No