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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ceylan GÜZEL İNAL, Lecturer, Şırnak Universty
  • Study Director: Sermin TİMUR TAŞHAN, Prof. Dr., İnonü 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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