Cancer PatientsNCT06115850
Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy
A study testing Music in people with Cancer Patients and Anxiety, run by Chung Shan Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients, Anxiety, Music Intervention
- What is being tested?
- Music
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Patients, Anxiety, Music Intervention, Radiation Therapy
- Being tested
- Music
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
The physiological indicators - Heart rate
Heart rate (Beat per minute ) were measured by a PHILIPS M1205A noninvasive physiological monitor.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: monitored before and after 2 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115850
- Sponsor's protocol ID
- 2022-a-037
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06115850
- Acronym / sponsor ID
- 2022-a-037
- Conditions
- Cancer Patients, Anxiety, Music Intervention, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: MusicAnxiety 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicIn 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. | Procedure or surgery | Music intervention |
Primary outcome
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.
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.
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.
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)
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Cancer Patients
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Cancer Patients and Anxiety, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The physiological indicators - Heart rate (time frame: monitored before and after 2 weeks of treatment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.