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

Not Applicable

Completed

• Conditions: Anxiety; Music Intervention; Radiation Therapy; Cancer Patients
• Interventions: Procedure: Music

• Registration Number: NCT06115850
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music intervention	Music	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.

Primary Outcome Measures

Name	Time	Method
The physiological indicators - Blood pressure	monitored before and after 2 weeks of treatment.	Blood pressure (mmHg) were measured by a PHILIPS M1205A noninvasive physiological monitor.
The physiological indicators - Blood oxygen	monitored before and after 2 weeks of treatment.	Blood oxygen (oxygen saturation，SO2 %) were measured by a PHILIPS M1205A noninvasive physiological monitor.
The physiological indicators - Heart rate	monitored before and after 2 weeks of treatment.	Heart rate (Beat per minute ) were measured by a PHILIPS M1205A noninvasive physiological monitor.
The anxiety status - Distress Thermometer	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)
The anxiety status - Brief Symptom Rating Scale (BSRS-5)	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.
The anxiety status - Beck Anxiety Inventory (BAI-C)	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).
The anxiety status - Symptom Distress Thermometer (SDT)	monitored before and after 2 weeks of treatment.	Symptom Distress Thermometer (SDT), a 10-point scale by the NCCN to evaluate distress levels.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung City, Taiwan (r.o.c.), Taiwan