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Completed

NCT Number: NCT06713408

Effects of Music and Affirmation Recital in Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amasya University

Amasya, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study title

Music and Affirmation Recital on Symptom Control, Psychological Resilience and Anxiety Levels

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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