NCT06713408

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

November 27, 2024

Last Update Submit

February 6, 2025

Conditions

Keywords

ChemotherapyMusic

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1 month

Study Arms (3)

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.

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.

Other: Experimental (Affirmation)

Control

NO INTERVENTION

No application will be made to these patients, and standard care practices will be continued.

Interventions

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 (Music)

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.

Experimental (Affirmation)

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 3, 2024

Study Start

October 31, 2024

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations