Music of Choice to Decrease Anxiety During Radiation Treatment

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University of Florida

Status

Completed

Conditions

Cancer
Anxiety

Treatments

Other: Music

Study type

Interventional

Funder types

Other

Identifiers

NCT03527225
IRB201703352
OCR17059 (Other Identifier)

Details and patient eligibility

About

The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.

Full 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.

Enrollment

135 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

135 participants in 2 patient groups

Music
Experimental group
Description:
Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource.
Treatment:
Other: Music
No Music
No Intervention group
Description:
These patient's will have no music playing during the first radiotherapy session.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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