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

Intrauterine Devices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277726
• Other study ID #: IU-SBE-CGI-01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Inonu University
• Contact: Ceylan l GÜZEL INAL, Lecturer
• Phone: +905432588644
• Email: cylngzl[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Devices

Intervention

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

Locations

Country	Name	City	State
Turkey	Sirnak State Hospital	Sirnak

Sponsors (2)

Lead Sponsor	Collaborator
Inonu University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	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.
Primary	State Anxiety Inventory	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.