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

May 12, 2025 updated by: Sümeyye Köse
This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pendik
      • Istanbul, Pendik, Turkey, 34890
        • Pendik District Health Directorate Maternal Child Health and Family Planning Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Women in the intervention group applying for IUD application will listen to music for 5 minutes before, during and after the procedure.
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.
No Intervention: Control Group
Women in the control group applying for IUD application will not be subjected to any intervention other than routine IUD insertion procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 30 minütes
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
Pain Level
Time Frame: 30 minütes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction Level
Time Frame: 30 minütes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sümeyye Köse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SKOSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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