Music of Choice to Decrease Anxiety During Radiation Treatment

Not Applicable

Completed

• Conditions: Cancer; Anxiety
• Interventions: Other: Music

• Registration Number: NCT03527225
• Lead Sponsor: University of Florida

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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.

Read More

Exclusion Criteria

• Prior history of radiation therapy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music	Music	Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource.

Primary Outcome Measures

Name	Time	Method
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.	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 Outcome Measures

Name	Time	Method
Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.	baseline	Percentage change in mean anxiety score as measured with the Symptom Distress Thermometer (SDT). Scale of 0 - 10; with 10 being clinically significant distress.
Magnitude change of STAI Score	baseline	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.
Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.	baseline	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.
STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.	baseline	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.
SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.	baseline	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.

Trial Locations

Locations (1)

University of Florida Health Cancer Center; 🇺🇸 Gainesville, Florida, United States