Clinical trial NCT05499000: The Effect of Emotional Freedom Technique on Premenstrual Syndrome
Official title: The Effect of Emotional Freedom Technique on Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Emotional Problem
Keywords: Emotional Freedom Technique
Premenstruel Sendrom
Midwifery
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Subjective Units of Experience- (SUE)
timeFrame: Each participant will be evaluated for 1 week.
Secondary outcomes:
measure: Descriptive Data- (KBF)
timeFrame: It will be obtained in 1 week at the beginning of the research.
measure: Premenstrual Syndrome Scale- (PMSS)
timeFrame: 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.
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Faculty of Health Sciences
Study officials:
affiliation: https://www.inonu.edu.tr/akademik/zeliha.ozsahin
name: Zeliha OZSAHİN, PhD
role: STUDY_DIRECTOR
affiliation: https://www.inonu.edu.tr/akademik/yesim.aksoy
name: Yeşim AKSOY DERYA, PhD
role: STUDY_CHAIR
affiliation: https://saglikbilimleri.ozal.edu.tr/?page_id=7732
name: Çiğdem KARAKAYALI AY, PhD
role: STUDY_CHAIR
References: