The Effect of Music on Pain, Anxiety and Satisfaction During Mammography

Breast Cancer Clinical Trial

Official title:

The Effect of Music on Pain, Anxiety and Satisfaction During Mammography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222684
• Other study ID #: SumeyyeKose
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: Saglik Bilimleri Universitesi
• Contact: Sumeyye Kose
• Phone: 2163961630
• Email: sumeyyekose28[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The randomized controlled and experimental study will be conducted with 70 women who apply to the Cancer Early Diagnosis, Screening and Training Center for mammography screening. Women in the experimental group (n=35) will listen to music before, during and after mammography screening, and women in the control group (n=35) will undergo routine mammography screening. Information Form Containing Sociodemographic Information and Situational Anxiety Inventory will be used to collect data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 30, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• The woman has a cognitive and auditory problem

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Breast Cancer
• Pain

Intervention

Other:
• Music therapy
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.

Locations

Country	Name	City	State
Turkey	Pendik District Health Directorate Maternal Child Health and Family Planning Center	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Satisfaction Level	Data will be collected using the Visual Analog Scale. Satisfaction can be given a score between 0 and 10 on the scale. The higher the scale score, the higher the satisfaction level.	20 minutes