- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06115850
Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy
October 30, 2023 updated by: Chung Shan Medical University
Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy: A Randomized Clinical Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taiwan (r.o.c.)
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Taichung City, Taiwan (r.o.c.), Taiwan, 408025
- Chung Shan Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No Music 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.
|
|
Experimental: Music 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
monitored before and after 2 weeks of treatment.
|
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.
|
monitored before and after 2 weeks of treatment.
|
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.
|
monitored before and after 2 weeks of treatment.
|
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)
|
monitored before and after 2 weeks of treatment.
|
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.
|
monitored before and after 2 weeks of treatment.
|
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).
|
monitored before and after 2 weeks of treatment.
|
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.
|
monitored before and after 2 weeks of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
October 26, 2023
First Submitted That Met QC Criteria
October 30, 2023
First Posted (Estimated)
November 3, 2023
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-a-037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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