The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application

Pain Clinical Trial

Official title:

The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215183
• Other study ID #: SKOSE
• 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: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction.

Description:

The randomized controlled and experimental study will be conducted with 70 women who apply to a Maternal and Child Health and Family Planning Center to have an Intrauterine Device (IUD). Women in the experimental group (n=35) will listen to music before, during and after the IUD application process, and the control group (n=35) will undergo routine IUD application. Information Form containing sociodemographic information, Situational Anxiety

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Knowing how to read and write,
• Not having had an IUD inserted before,
• Being between the ages of 18-49,
• 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
• Having a history of cervical surgery

Related Conditions & MeSH terms

• Pain
• Reproductive Health
• Women Health

Intervention

Other:
• Music therapy
Women applying for IUD application will receive music therapy for 5 minutes before the procedure, during the IUD application, 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
Sümeyye Köse

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.	30 minütes
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.	30 minütes
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.	30 minütes