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Completed

NCT Number: NCT06115850

Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy

This prospective randomized trial evaluated the effect of music interventions on anxiety and nervousness during 10 consecutive days in individuals undergoing their first radiation therapy session.

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Key information

Conditions

Cancer Patients Anxiety Anxiety Disorders Mental Disorders Music Intervention Radiation Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, Taiwan (r.o.c.), 408025, Taiwan

About this study

A total of 100 participants were enrolled and randomly assigned to either the music group or nonmusic group (n = 50 each). Investigators ensured an equal distribution of men and women, without considering the cancer type. To minimize confounding factors and prevent shared learning experiences or communication between the two groups, the participants in the experimental and control groups were scheduled for treatment at different times throughout the year (from January 1, 2022 to December 31, 2022). Anxiety assessment questionnaires were administered before the treatment began and after 2 weeks of treatment. Physiological parameters, including heart rate, systolic and diastolic blood pressure, and blood oxygen levels, were monitored before and after 2 weeks of treatment. In the music intervention group, the patients received music intervention during RT for 10 consecutive days and listened to music for approximately 10-15 minutes in each session. The music period was then followed by a 10-day period without music during treatment to evaluate the differences in the same individuals. In contrast, the control group did not receive music intervention throughout their entire RT period. Investigators observed the music intervention group for 2 weeks to ascertain any differences.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing RT for cancer for the first time
  • patients with clear consciousness and normal hearing
  • patients willing to respond to the questionnaire after the research process and purpose were explained to them.

Exclusion criteria

  • patients who had previously undergone RT
  • patients with diminished mental capacity or inability to satisfactorily participate in this study
  • patients with moderate to severe hearing impairment.

Treatment and study plan

Music

Procedure

In the music intervention group, the patients received music intervention during RT for 10 consecutive days and listened to music for approximately 10-15 minutes in each session.

Primary outcomes

  1. The physiological indicators - Heart rate

    Time frame: monitored before and after 2 weeks of treatment.

    Heart rate (Beat per minute ) were measured by a PHILIPS M1205A noninvasive physiological monitor.

  2. The physiological indicators - Blood pressure

    Time frame: monitored before and after 2 weeks of treatment.

    Blood pressure (mmHg) were measured by a PHILIPS M1205A noninvasive physiological monitor.

  3. The physiological indicators - Blood oxygen

    Time frame: monitored before and after 2 weeks of treatment.

    Blood oxygen (oxygen saturation，SO2 %) were measured by a PHILIPS M1205A noninvasive physiological monitor.

  4. The anxiety status - Distress Thermometer

    Time frame: monitored before and after 2 weeks of treatment.

    Distress Thermometer (DT) which screens for psychological distress in patients with cancer as recommended by the National Comprehensive Cancer Network® (NCCN)

  5. The anxiety status - Brief Symptom Rating Scale (BSRS-5)

    Time frame: monitored before and after 2 weeks of treatment.

    Brief Symptom Rating Scale (BSRS-5) or "Mood Thermometer," a 5-point Likert scale for assessing symptoms of emotional distress over 1 week. The total score ranges from 0 to 20.

  6. The anxiety status - Beck Anxiety Inventory (BAI-C)

    Time frame: monitored before and after 2 weeks of treatment.

    Beck Anxiety Inventory (BAI-C, a 21-item self-reported questionnaire to assess anxiety symptoms on a 4-point scale, which has shown excellent internal consistency and test-retest reliability).

  7. The anxiety status - Symptom Distress Thermometer (SDT)

    Time frame: monitored before and after 2 weeks of treatment.

    Symptom Distress Thermometer (SDT), a 10-point scale by the NCCN to evaluate distress levels.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2023
Registry last updated
Nov 3, 2023

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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