Music of Choice to Decrease Anxiety During Radiation Treatment

Cancer Clinical Trial

Official title:

A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527225
• Other study ID #: IRB201703352
• Secondary ID: OCR17059
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer

Intervention

Other:
• Music
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.

Locations

Country	Name	City	State
United States	University of Florida Health Cancer Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Secondary	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.	baseline
Secondary	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.	baseline
Secondary	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.	baseline
Secondary	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.	baseline
Secondary	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.	baseline