Breast CancerNCT06713408
Effects of Music and Affirmation Recital in Women With Breast Cancer
A study testing Experimental (Music) and Experimental (Affirmation) in people with Breast Cancer, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Experimental (Music) and Experimental (Affirmation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2024to 6 Feb 2025
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those diagnosed with breast cancer
- Those who have received at least 1 course of chemotherapy
- Those over the age of 18
- Those who agree to participate in the study
Who cannot join
- Those who are not receiving curative chemotherapy
- Those who do not have a phone to listen to music and affirmations
- Those who do not agree to participate in the study
- Those with mental and neuropsychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music and Affirmation Recital on Symptom Control, Psychological Resilience and Anxiety Levels
The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer.
Read the detailed description
Introduction: Music therapy is attracting attention today because it is a person-centered approach that does not require any special skills and/or significant financial investments.
Method: The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer. This study will be conducted using a randomized controlled trial design. It is planned to include 75 women in total, 25 patients in the music recital group, 25 patients in the music and affirmation group and 25 patients in the control group. Data in the study will be collected using the Introductory Information Form, Edmonton Symptom Diagnostic Scale, State Anxiety Scale and Psychological Resilience Scale.
Conclusion: It is thought that the findings obtained in this study will contribute to the use of music and affirmation, which are cheap, effective and easily applicable methods, in chemotherapy units as a method to help reduce patients' anxiety. The study is expected to reduce the symptoms of breast cancer patients and reduce their anxiety levels
- Conditions
- Breast Cancer
- Being tested
- Experimental (Music), Experimental (Affirmation)
- Keywords
- Chemotherapy, Music
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Music)Other
Audio recordings consisting of pentatonic music and neva makam will be uploaded to the patients' phones by the researcher. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy.
Experimental (Affirmation)Other
Patients in this group will be asked to listen to the audio recording with pentatonic music and neva makam in the background, along with the affirmation sentences provided in the appendix. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Music) | Experimental | Audio recordings consisting of pentatonic music and neva makam will be uploaded to the patients' phones by the researcher. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy. Receives: Other: Experimental (Music) |
| Experimental (Affirmation) | Experimental | Patients in this group will be asked to listen to the audio recording with pentatonic music and neva makam in the background, along with the affirmation sentences provided in the appendix. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy. Receives: Other: Experimental (Affirmation) |
| Control | No intervention | No application will be made to these patients, and standard care practices will be continued. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Diagnostic Scale
This scale is used to measure cancerous voice, youth, medium units, durable, anxiety, sleepiness, excitement, feeling good and shortness of breath. The measurement of the degree of feeling to be measured from the numbers 0 to 10 on a line on the scale. In the scale, 0 represents no hissing of the symptom, 10 represents very strong hissing. The Turkish validity and publication study of the scale was published by Kurt and Unsar and the Cronbach alpha value works as 0.70.
Measured: 1 month
Beck Anxiety Inventory
Beck Anxiety Inventory: Developed by Beck et al. (1988) to determine the level and frequency of anxiety symptoms experienced by an individual. The scale is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The high total score indicates the high level of anxiety experienced by the individual. The score range varies between 0-63. The scale is evaluated as 0-7 points, no anxiety symptoms, 8-15 points, mild anxiety, 16-25 points, moderate anxiety, 26-63 points, severe anxiety symptoms. The validity and reliability study in our country was conducted by Ulusoy et al. (1998) and the Cronbach alpha value of the scale was found to be 0.93.
Measured: 1 month
Brief Resilience Scale
The scale was developed by Smith in 2008, and its Turkish validity and reliability study was conducted by Doğan in 2015. Brief Resilience Scale is a 5-point Likert-type self-report measurement tool consisting of 6 items. The answers are "Not at all appropriate (1), Not appropriate (2), Somewhat appropriate (3), Appropriate (4), Completely appropriate (5)". Items 2, 4, and 6 of the scale are reverse coded. The score obtained from the scale varies between 1 and 30. High scores obtained indicate high psychological resilience. In the validity and reliability study, the Cronbach alpha reliability value of the scale was found to be 0.83.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start31 Oct 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713408
- Sponsor's protocol ID
- AmasyaU-NU-789
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uysal N, Unal Toprak F, Sahingoz Alpargan M. The effect of music and affirmation listening on symptom management, psychological resilience, and anxiety levels in women with breast cancer. Support Care Cancer. 2025 Oct 28;33(11):984. doi: 10.1007/s00520-025-10061-3.
PubMed 41145719
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music and Affirmation Recital on Symptom Control, Psychological Resilience and Anxiety Levels
- ClinicalTrials.gov ID
- NCT06713408
- Acronym / sponsor ID
- AmasyaU-NU-789
- Conditions
- Breast Cancer
- Keywords
- Chemotherapy, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 3 Dec 2024 (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.
The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer.
Detailed description
Introduction: Music therapy is attracting attention today because it is a person-centered approach that does not require any special skills and/or significant financial investments.
Method: The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer. This study will be conducted using a randomized controlled trial design. It is planned to include 75 women in total, 25 patients in the music recital group, 25 patients in the music and affirmation group and 25 patients in the control group. Data in the study will be collected using the Introductory Information Form, Edmonton Symptom Diagnostic Scale, State Anxiety Scale and Psychological Resilience Scale.
Conclusion: It is thought that the findings obtained in this study will contribute to the use of music and affirmation, which are cheap, effective and easily applicable methods, in chemotherapy units as a method to help reduce patients' anxiety. The study is expected to reduce the symptoms of breast cancer patients and reduce their anxiety levels
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental (Music) | Experimental | Other: Experimental (Music)Audio recordings consisting of pentatonic music and neva makam will be uploaded to the patients' phones by the researcher. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy. |
| Experimental (Affirmation) | Experimental | Other: Experimental (Affirmation)Patients in this group will be asked to listen to the audio recording with pentatonic music and neva makam in the background, along with the affirmation sentences provided in the appendix. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy. |
| Control | No intervention | –No application will be made to these patients, and standard care practices will be continued. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those diagnosed with breast cancer
- Those who have received at least 1 course of chemotherapy
- Those over the age of 18
- Those who agree to participate in the study
Key exclusion criteria (4 listed)
- Those who are not receiving curative chemotherapy
- Those who do not have a phone to listen to music and affirmations
- Those who do not agree to participate in the study
- Those with mental and neuropsychiatric diseases
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 |
|---|---|---|
| Experimental (Music)Audio recordings consisting of pentatonic music and neva makam will be uploaded to the patients' phones by the researcher. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy. | Other | Experimental (Music) |
| Experimental (Affirmation)Patients in this group will be asked to listen to the audio recording with pentatonic music and neva makam in the background, along with the affirmation sentences provided in the appendix. Patients will be advised to listen to these music during the period they receive chemotherapy, and they will also be asked to listen to these music in at least 15-20 minute sessions per day and for at least 3 days during the week following chemotherapy. | Other | Experimental (Affirmation) |
Primary outcome
Edmonton Symptom Diagnostic Scale
Time frame: 1 month
This scale is used to measure cancerous voice, youth, medium units, durable, anxiety, sleepiness, excitement, feeling good and shortness of breath. The measurement of the degree of feeling to be measured from the numbers 0 to 10 on a line on the scale. In the scale, 0 represents no hissing of the symptom, 10 represents very strong hissing. The Turkish validity and publication study of the scale was published by Kurt and Unsar and the Cronbach alpha value works as 0.70.
Beck Anxiety Inventory
Time frame: 1 month
Beck Anxiety Inventory: Developed by Beck et al. (1988) to determine the level and frequency of anxiety symptoms experienced by an individual. The scale is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The high total score indicates the high level of anxiety experienced by the individual. The score range varies between 0-63. The scale is evaluated as 0-7 points, no anxiety symptoms, 8-15 points, mild anxiety, 16-25 points, moderate anxiety, 26-63 points, severe anxiety symptoms. The validity and reliability study in our country was conducted by Ulusoy et al. (1998) and the Cronbach alpha value of the scale was found to be 0.93.
Brief Resilience Scale
Time frame: 1 month
The scale was developed by Smith in 2008, and its Turkish validity and reliability study was conducted by Doğan in 2015. Brief Resilience Scale is a 5-point Likert-type self-report measurement tool consisting of 6 items. The answers are "Not at all appropriate (1), Not appropriate (2), Somewhat appropriate (3), Appropriate (4), Completely appropriate (5)". Items 2, 4, and 6 of the scale are reverse coded. The score obtained from the scale varies between 1 and 30. High scores obtained indicate high psychological resilience. In the validity and reliability study, the Cronbach alpha reliability value of the scale was found to be 0.83.
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 10 Feb 2025.
- Derived from this study: PubMed 41145719Uysal N, Unal Toprak F, Sahingoz Alpargan M. The effect of music and affirmation listening on symptom management, psychological resilience, and anxiety levels in women with breast cancer. Support Care Cancer. 2025 Oct 28;33(11):984. doi: 10.1007/s00520-025-10061-3.
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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 Experimental (Music) and Experimental (Affirmation) in people with Breast Cancer, run by Amasya University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 10 Feb 2025. 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 Turkey (Türkiye). 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?
Edmonton Symptom Diagnostic Scale (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713408, which also lists 1 linked publication.
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 10 Feb 2025.