A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- University of Florida
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.
Detailed Description
Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled to receive radiotherapy for malignant tumor
- •ECOG Performance Status 0-4
- •Fluent in English Language
- •Inclusion in this study will not be based on race or ethnicity
- •Patients must be deemed able to comply with the treatment plan.
- •Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria
- •Prior history of radiation therapy
Outcomes
Primary Outcomes
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Time Frame: baseline
Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety.
Secondary Outcomes
- Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)
- Magnitude change of STAI Score(baseline)
- Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)
- STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)
- SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)