- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06713408
Effects of Music and Affirmation Recital in Women With Breast Cancer
Music and Affirmation Recital on Symptom Control, Psychological Resilience and Anxiety Levels
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Amasya, Turkey
- Amasya University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
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|
Experimental: 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.
|
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.
|
|
No Intervention: Control
No application will be made to these patients, and standard care practices will be continued.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1 month
|
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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.
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1 month
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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.
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1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AmasyaU-NU-789
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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