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

NCT ID: NCT06277726

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intrauterine Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study with pre-test post-test group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
In order to ensure randomization and prevent contamination between groups, data will be collected in a sequence such that emotional freedom technique is collected one week, music is collected one week, and control group data is collected one week. It will be decided by drawing lots which group's data will be collected first.

Study Groups

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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.

Group Type EXPERIMENTAL

Emotional freedom technique group

Intervention Type OTHER

Emotional freedom technique will be applied to women in this group before intrauterine device application.

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.

Group Type EXPERIMENTAL

Music group

Intervention Type OTHER

Women in this group will wear headphones and listen to music throughout the intrauterine device application.

Control group

No intervention will be applied to women in the control group.

Group Type OTHER

Control group

Intervention Type OTHER

No intervention will be applied to women in the control group.

Interventions

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Emotional freedom technique group

Emotional freedom technique will be applied to women in this group before intrauterine device application.

Intervention Type OTHER

Music group

Women in this group will wear headphones and listen to music throughout the intrauterine device application.

Intervention Type OTHER

Control group

No intervention will be applied to women in the control group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ceylan Guzel Inal

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ceylan GÜZEL İNAL, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Şırnak Universty

Sermin TİMUR TAŞHAN, Prof. Dr.

Role: STUDY_DIRECTOR

İnönü Universty

Locations

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Şırnak State Hospital

Şırnak, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ceylan l GÜZEL İNAL, Lecturer

Role: CONTACT

+905432588644

Sermin TİMUR TAŞHAN, Prof. Dr.

Role: CONTACT

+905066047909

Facility Contacts

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Ceylan GÜZEL İNAL, Lecturer

Role: primary

+095432588644

Other Identifiers

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IU-SBE-CGI-01

Identifier Type: -

Identifier Source: org_study_id

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