NCT06222684

Brief Summary

This study was planned to determine the effect of music listened to during mammography screening on pain, anxiety and satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

January 9, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

mammographypainmusic therapy

Outcome Measures

Primary Outcomes (2)

  • Anxiety

    Data will be collected using the State Anxiety Inventory. The answer options collected in four classes on the State Anxiety Inventory scale are: (1) Not at all, (2) A little, (3) A lot and (4) Completely; The options on the trait anxiety scale are (1) Rarel, (2) Sometimes, (3) A lot of the time, and (4) Almost always. The higher the score obtained from the scales, the higher the person's anxiety is. The total score obtained from the scale varies between 20-80, and 20-39 indicates a mild anxiety level, 40-59 indicates a medium anxiety level, 60-79 indicates a high anxiety level, and 80 points indicates a panic anxiety level.

    20 minutes

  • Pain Level

    Data will be collected using the Visual Analogue Scale. Pain can be given a score between 0 and 10 on the scale.The higher the scale score, the greater the pain.

    20 minutes

Secondary Outcomes (1)

  • Satisfaction Level

    20 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Women in the intervention group applying for mammography screening will listen to music for 5 minutes before, during and after the procedure.

Other: Music therapy

Control Group

NO INTERVENTION

Women in the control group applying for mammography screening will not receive any intervention other than routine mammography screening.

Interventions

Women applying for mammography screening will receive music therapy for 5 minutes before the procedure, during the mammography scan and for 5 minutes after the procedure.

Intervention Group

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knowing how to read and write,
  • Not having had a mammogram before,
  • Being between the ages of 40-69,
  • No hearing-related problems,
  • Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
  • Voluntarily participating in the study,

You may not qualify if:

  • \- The woman has a cognitive and auditory problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pendik District Health Directorate Maternal Child Health and Family Planning Center

Istanbul, Pendik, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsPainAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The evaluation was made by the participants in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 25, 2024

Study Start

February 1, 2024

Primary Completion

April 20, 2024

Study Completion

April 30, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations