The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application.

February 18, 2024 updated by: Ceylan Guzel Inal, Inonu University

The Effect of Emotional Freedom Technique and Music Recital on Pain and Anxiety Experienced During Intrauterine Device Application

The purpose of this study is to determine the effect of emotional freedom technique and music, which are effective in relieving pain and anxiety, on the pain and anxiety that occur during intrauterine device application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intrauterine devices, which are considered one of the most effective contraceptive methods, can be effective up to 99% when used correctly. While 17% of women of reproductive age around the world use intrauterine devices, 13.7% of women in our country prefer intrauterine devices as a contraceptive method. Intrauterine devices have many benefits such as being easy to use, returning fertility when removed, being able to be used for a long time, and being low in cost. Intrauterine devices are recommended to women as the first choice by medical institutions due to their high effectiveness rates. However, anxiety and pain experienced during the intrauterine device placement procedure may prevent women from choosing intrauterine devices as a birth control method. Music and emotional liberation techniques can be used as alternative methods to relieve pain and anxiety. In this research, the effects of emotional freedom technique and music, which are effective on pain and anxiety, on pain and anxiety during intrauterine device application will be investigated. Additionally, it will be tested whether the emotional liberation technique and music are superior to each other in relieving the pain and anxiety that occur during intrauterine device application. Additionally, no research has been found in the literature examining the effects of emotional liberation technique and music recital on the pain and anxiety experienced during intrauterine device application. With this research, the gap in the field will be eliminated and new research and applications will be structured.

Study Type

Interventional

Enrollment (Estimated)

168

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 Contact

Study Contact Backup

  • Name: Sermin TİMUR TAŞHAN, Prof. Dr.
  • Phone Number: +905066047909
  • Email: setimur@gmail.com

Study Locations

  • Turkey
      • Şırnak, Turkey, 73000
        • Recruiting
        • Şırnak State Hospital
        • Contact:

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:

  • Voluntarily agreeing to participate in the research
  • Being between the ages of 18-49

Exclusion Criteria:

  • Having a verbal communication problem
  • Being medically diagnosed with a psychiatric disorder
  • Presence of wounds, scars and infections in the areas touched in the emotional freedom technique
  • Having a hearing problem
  • Having had an intrauterine device (IUD) inserted before
  • Being exposed to domestic violence
  • Being diagnosed with any medical condition (hypertension, diabetes, etc.)
  • Having used analgesics seven hours before the procedure
  • Having a gynecological examination just before IUD application

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emotional freedom technique group
Pre-test data will be collected after women are informed about the emotional freedom technique. After the pre-test data is collected, the emotional liberation technique will be applied to the women. After the emotional liberation technique session is completed, the intrauterine device (IUD) will be applied. Post-test data will be collected within 10 minutes after IUD application is completed.
Other: Emotional freedom technique group
Emotional freedom technique will be applied to women in this group before intrauterine device application.
Experimental: Music group
Women in the music group will be informed about the procedure steps before intrauterine device (IUD) application and pre-test data will be collected. After the pre-test data is collected, the music list prepared by the women and researchers will be shown and the women will be asked to choose a piece. Women who do not want to listen to any music on this list will be allowed to listen to the music they prefer. The music concert will be performed with headphones, and women will be asked to listen to the music until the IUD application process is completed. Post-test data will be collected within 10 minutes after IUD application.
Other: Music group
Women in this group will wear headphones and listen to music throughout the intrauterine device application.
Other: Control group
No intervention will be applied to women in the control group.
Other: Control group
No intervention will be applied to women in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: It will be used for 10 months, which is the data collection period. It will be used before and ten minutes after intrauterine device application.
A visual analog scale will be used to measure the pain caused by intrauterine device application. It is a two-ended scale that is used to measure the intensity of pain and is graded on a horizontal line, with one end starting from 0 and the other end ending at 10. The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The numerical value marked by the patient indicates the severity of pain. A VAS value of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-9 indicates severe pain, and 10 indicates unbearable pain.
It will be used for 10 months, which is the data collection period. It will be used before and ten minutes after intrauterine device application.
State Anxiety Inventory
Time Frame: It will be used for 10 months, which is the data collection period. It will be used before and ten minutes after intrauterine device application.
State anxiety inventory; It is a scale consisting of 20 questions that include the options of (1) not at all, (2) a little, (3) quite a bit, (4) completely, depending on the severity of the emotions at that moment, so that the individual can describe how he feels at a certain moment. Accordingly, the total score obtained from the scale can vary between 20 and 80. A high score from the scale indicates a high level of anxiety.
It will be used for 10 months, which is the data collection period. It will be used before and ten minutes after intrauterine device application.

Collaborators and Investigators

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

Sponsor

Inonu University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Ceylan GÜZEL İNAL, Lecturer, Şırnak Universty
  • Study Director: Sermin TİMUR TAŞHAN, Prof. Dr., İnönü Universty

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)

July 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IU-SBE-CGI-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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