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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06115850
• Other study ID #: 2022-a-037
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer Patients
• Music Intervention
• Radiation Therapy

Intervention

Procedure:
• Music
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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung City	Taiwan (r.o.c.)

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The physiological indicators - Heart rate	Heart rate (Beat per minute ) were measured by a PHILIPS M1205A noninvasive physiological monitor.	monitored before and after 2 weeks of treatment.
Primary	The physiological indicators - Blood pressure	Blood pressure (mmHg) were measured by a PHILIPS M1205A noninvasive physiological monitor.	monitored before and after 2 weeks of treatment.
Primary	The physiological indicators - Blood oxygen	Blood oxygen (oxygen saturation,SO2 %) were measured by a PHILIPS M1205A noninvasive physiological monitor.	monitored before and after 2 weeks of treatment.
Primary	The anxiety status - Distress Thermometer	Distress Thermometer (DT) which screens for psychological distress in patients with cancer as recommended by the National Comprehensive Cancer Network® (NCCN)	monitored before and after 2 weeks of treatment.
Primary	The anxiety status - Brief Symptom Rating Scale (BSRS-5)	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.	monitored before and after 2 weeks of treatment.
Primary	The anxiety status - Beck Anxiety Inventory (BAI-C)	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).	monitored before and after 2 weeks of treatment.
Primary	The anxiety status - Symptom Distress Thermometer (SDT)	Symptom Distress Thermometer (SDT), a 10-point scale by the NCCN to evaluate distress levels.	monitored before and after 2 weeks of treatment.