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The Effect of Emotional Freedom Technique on Premenstrual Syndrome

Primary Purpose

Premenstrual Syndrome, Emotional Problem

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Emotional freedom technique
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premenstrual Syndrome focused on measuring Emotional Freedom Technique, Premenstruel Sendrom, Midwifery

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • To be between 18-25,
  • Single,
  • Not to use anything pharmacological or non-pharmacological during the research,
  • Not having a diagnosed psychiatric disease such as epilepsy.

Exclusion Criteria:

  • Willingness to leave during research.

Sites / Locations

  • Inonu University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Emotional freedom technique will be applied online with the researcher in 2 sessions, 3 days apart. KBF, SUE, PMSS pre-tests will be applied before the intervention, SUE will be applied before and after each session, At the end of the second session, post-test data will be obtained with SUE, PMSS.

KBF, SUE and PMSS pre-tests will be applied to the participants, SUE, PMSS and post-test data will be obtained simultaneously with the experimental group.

Outcomes

Primary Outcome Measures

Subjective Units of Experience- (SUE)
The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables.

Secondary Outcome Measures

Descriptive Data- (KBF)
The personal information form prepared by the researcher in line with the literature consists of socio-demographic (age, education and employment status, income status, family type and place of residence), obstetric (age of menarche, menstrual cycle duration), psycho-social and medical history questions.
Premenstrual Syndrome Scale- (PMSS)
The reliability and validity study of the Premenstrual Syndrome Scale was performed by Gençdoğan (2006). The scale used to determine premenstrual symptoms and their severity is a 5-point Likert type and consists of 44 items. The scale has nine sub-dimensions: depressive affect, anxiety, irritability, fatigue, depressive thoughts, pain, changes in appetite and bloating. The lowest score that can be obtained from these nine sub-dimensions is 44, and the highest score is 220. A high score indicates that the intensity of premenstrual symptoms is high. The Cronbach alpha coefficient of the scale was found to be 0.75 (Gencdogan, 2006).

Full Information

First Posted
August 7, 2022
Last Updated
September 25, 2023
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05499000
Brief Title
The Effect of Emotional Freedom Technique on Premenstrual Syndrome
Official Title
The Effect of Emotional Freedom Technique on Premenstrual Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: This study was conducted to evaluate the Effect of Emotional Freedom Technique on Premenstrual Syndrome. Methodology: The research will be conducted as a randomized controlled trial. The research will be carried out with students studying at the Department of Midwifery, Faculty of Health Sciences, İnönü University, between September and October 2022. The sample size of the study was calculated as 102 people with an effect size of 0.80 and a power of 0.95. Premenstrual syndrome scale will be applied to all students participating in the research first and those who score 110 and above will be listed. Experimental and control groups will be determined by randomization. Personal information form, subjective experience unit scale and premenstrual syndrome scale will be used to collect data. SPSS 22.0 package program will be used in the evaluation of the data. The independent variable of the research is the emotional liberation technique. The dependent variable of the study is the mean scores of the participants from the subjective experience unit scale and premenstrual syndrome scale.
Detailed Description
Menstruation is an important process accompanied by physiological and psychological fluctuations covering a long part of a woman's life. Premenstrual syndrome (PMS) is characterized by cyclical repetition of physical, psychological and behavioral symptoms that start one week before menstruation, gradually increasing in severity, and end with menstruation [1-3]. Presence of at least one of six affective symptoms (anger outburst, depression, anxiety, confusion, irritability, and social withdrawal) and one of four somatic symptoms (abdominal swelling, headache, breast tenderness, and swelling in the extremities) according to the American Association of Obstetricians and Gynecologists (ACOG). It states that if the symptoms disappear 4 days after the onset of the disease, and if it recurs cyclically, it meets the diagnostic criteria of PMS [4]. In studies conducted on PMS in various societies, its prevalence was determined to be in the range of 10-98% [5-8]. Although the etiology is not known exactly, the most common view is in the direction of serotonergic dysregulation. It is thought that the level of serotonin negatively affects the severity and intensity of PMS symptoms, and also triggers or exacerbates symptoms such as anxiety, appetite change and restlessness with the decrease in beta endorphin levels [9,10]. According to the severity level in PMS treatment; lifestyle changes (regular exercise, stress avoidance, regular sleep, etc.), combined oral contraceptives, serotonin selective inhibitors and cognitive behavioral therapies can be used [3, 11]. ACOG recommends using non-pharmacological treatments rather than pharmacological treatments for mild symptoms with psychological predominance [4]. Although it has a history of thousands of years in eastern cultures, it argues that the methods of energy psychology that we have encountered in the last 40 years in western societies and that psychological problems are related to disturbances in the energy fields of the body. According to energy psychology, people are physiological, emotional, mental and behavioral whole and in harmony. When the harmony is disturbed, psychological symptoms occur, and treatment is aimed by regulating the energy frequency by taking initiatives for this [12, 13]. In this context, Emotional Freedom Technique (EFT) is a psychophysiological method that provides easy and fast results to manage the normal energy flow on the energy body of the person [14, 15]. The main purpose of EFT is; It is to transform the negative energy frequency of the person into a positive one by clearing the negative emotions and thoughts that the person has subconsciously created or carried from the past by himself or environmental influences [14]. In the 1980s, thought field therapy, which was applied with strokes/touches to human meridian points with a complex algorithmic order, was simplified by Craig and started to apply with a single algorithmic order, thus EFT emerged [16, 17]. EFT is applied with strokes/touches as a somatic stimulus applied to meridian points, which includes stimulating the subconscious as in cognitive behavioral therapies, accepting a negative situation or emotion as in exposure therapy. It is frequently used in the treatment of psychological symptoms in current studies because it is easy to apply in opening the blockages in the energy body or converting the negative frequency to positive and has a quick result [18]. There are studies showing that EFT has positive effects on variables such as anxiety [14], phobias [15], posttraumatic stress disorder [16] and depression [17]. In the field of women's health, the effects of EFT studies on psychological development and cortisol levels in pregnant women with prenatal loss [18], fear of childbirth [19], dysmenorrhea [20] and postpartum depression [21] The results are extremely positive. In this context, it is thought that the research will contribute to the literature due to the insufficiency of studies examining the effect of EFT application on premenstrual syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Emotional Problem
Keywords
Emotional Freedom Technique, Premenstruel Sendrom, Midwifery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Emotional freedom technique will be applied online with the researcher in 2 sessions, 3 days apart. KBF, SUE, PMSS pre-tests will be applied before the intervention, SUE will be applied before and after each session, At the end of the second session, post-test data will be obtained with SUE, PMSS.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
KBF, SUE and PMSS pre-tests will be applied to the participants, SUE, PMSS and post-test data will be obtained simultaneously with the experimental group.
Intervention Type
Behavioral
Intervention Name(s)
Emotional freedom technique
Intervention Description
Emotional freedom technique will be applied online with the researcher in 2 sessions, 3 days apart. KBF, SUE, PMSS tests will be applied before the intervention, SUE will be applied before and after each session, At the end of the 2nd session, post-test data will be taken with SUE, PMSS.
Primary Outcome Measure Information:
Title
Subjective Units of Experience- (SUE)
Description
The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables.
Time Frame
Each participant will be evaluated for 1 week.
Secondary Outcome Measure Information:
Title
Descriptive Data- (KBF)
Description
The personal information form prepared by the researcher in line with the literature consists of socio-demographic (age, education and employment status, income status, family type and place of residence), obstetric (age of menarche, menstrual cycle duration), psycho-social and medical history questions.
Time Frame
It will be obtained in 1 week at the beginning of the research.
Title
Premenstrual Syndrome Scale- (PMSS)
Description
The reliability and validity study of the Premenstrual Syndrome Scale was performed by Gençdoğan (2006). The scale used to determine premenstrual symptoms and their severity is a 5-point Likert type and consists of 44 items. The scale has nine sub-dimensions: depressive affect, anxiety, irritability, fatigue, depressive thoughts, pain, changes in appetite and bloating. The lowest score that can be obtained from these nine sub-dimensions is 44, and the highest score is 220. A high score indicates that the intensity of premenstrual symptoms is high. The Cronbach alpha coefficient of the scale was found to be 0.75 (Gencdogan, 2006).
Time Frame
It will take an average of 1 month to obtain the data. Measured PMSS scale data will be reported within 2 weeks at the end of the study.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be between 18-25, Single, Not to use anything pharmacological or non-pharmacological during the research, Not having a diagnosed psychiatric disease such as epilepsy. Exclusion Criteria: Willingness to leave during research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeliha OZSAHİN, PhD
Organizational Affiliation
https://www.inonu.edu.tr/akademik/zeliha.ozsahin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yeşim AKSOY DERYA, PhD
Organizational Affiliation
https://www.inonu.edu.tr/akademik/yesim.aksoy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Çiğdem KARAKAYALI AY, PhD
Organizational Affiliation
https://www.inonu.edu.tr/akademik/cigdem.karakayali
Official's Role
Study Chair
Facility Information:
Facility Name
Inonu University Faculty of Health Sciences
City
Malatya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be obtained by Personal Information Form, Subjective Experience Units (SUE), Premenstrual Syndrome Scale (PMSS).

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The Effect of Emotional Freedom Technique on Premenstrual Syndrome

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