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

NCT06115850 | Completed

• 1 other identifier: 2022-a-037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Patients; Anxiety; Music Intervention; Radiation Therapy

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

No Music intervention

NO INTERVENTION

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.

Music intervention

EXPERIMENTAL

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.

Procedure: Music

Interventions

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.

Music intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

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

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 3, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)