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Completed

NCT Number: NCT03527225

Music of Choice to Decrease Anxiety During Radiation Treatment

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

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Key information

Conditions

Anxiety Anxiety Disorders Cancer Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Health Cancer Center

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

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.

Primary outcomes

  1. 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

  1. Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.

    Time frame: 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.

  2. Magnitude change of STAI Score

    Time frame: 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.

  3. Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.

    Time frame: 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.

  4. STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.

    Time frame: 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.

  5. SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 17, 2018
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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