The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application.
The Effect of Emotional Freedom Technique and Music Recital on Pain and Anxiety Experienced During Intrauterine Device Application
1 other identifier
interventional
168
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 18, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFebruary 26, 2024
February 1, 2024
9 months
February 18, 2024
February 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Study Arms (3)
Emotional freedom technique group
EXPERIMENTALPre-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.
Music group
EXPERIMENTALWomen 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.
Control group
OTHERNo intervention will be applied to women in the control group.
Interventions
Emotional freedom technique will be applied to women in this group before intrauterine device application.
Women in this group will wear headphones and listen to music throughout the intrauterine device application.
Eligibility Criteria
You may qualify if:
- Voluntarily agreeing to participate in the research
- Being between the ages of 18-49
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Şırnak State Hospital
Şırnak, 73000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ceylan GÜZEL İNAL, Lecturer
Şırnak Universty
- STUDY DIRECTOR
Sermin TİMUR TAŞHAN, Prof. Dr.
İnönü Universty
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 18, 2024
First Posted
February 26, 2024
Study Start
July 1, 2023
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
February 26, 2024
Record last verified: 2024-02