The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
135
The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.
University of Florida Health Cancer Center
Gainesville, Florida, United States
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
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.
Time frame: baseline
Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress.
Time frame: baseline
Magnitude change of STAI Score
The magnitude of change in anxiety score of STAI in "high anxiety" patients (pre-treatment STAI ≥ 40) as a result of listening to music during the first radiotherapy session.
Time frame: baseline
Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.
The magnitude of change in anxiety score of SDT in "high anxiety" patients (pre-treatment SDT ≥ 4) as a result of listening to music during the first radiotherapy session. Scale of 0 - 10; with 10 being clinically significant distress.
Time frame: baseline
STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using STAI scores. A score of 39-40 on each subset suggests clinically significant anxiety.
Time frame: baseline
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SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.
The number and percentage of patients who drop from a "high" to "low" anxiety level in both intervention groups using SDT scores. Scale of 0 - 10; with 10 being clinically significant distress.
Time frame: baseline