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Premenstrual SyndromeNCT05499000

The Effect of Emotional Freedom Technique on Premenstrual Syndrome

A study testing Emotional freedom technique in people with Premenstrual Syndrome and Emotional Problem, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Premenstrual Syndrome, Emotional Problem
What is being tested?
Emotional freedom technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2022to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Willingness to leave during research.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Inonu University Faculty of Health Sciences

    Malatya

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Emotional freedom technique
Keywords
Emotional Freedom Technique, Premenstruel Sendrom, Midwifery
Medical subject headings
Premenstrual Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional freedom techniqueBehavioural

    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.

Study groups in NCT05499000
Study groupRoleWhat they receive
Experimental groupExperimentalEmotional 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.
Receives: Behavioral: Emotional freedom technique
Control groupNo interventionKBF, 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Each participant will be evaluated for 1 week.

Secondary outcomes (2)
  1. 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.

    Measured: It will be obtained in 1 week at the beginning of the research.

  2. 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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499000
Sponsor's protocol ID
Faculty of Health Science
Status last verified
Mar 2024
First submitted
7 Aug 2022
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be obtained by Personal Information Form, Subjective Experience Units (SUE), Premenstrual Syndrome Scale (PMSS).

Questions about this trial

What is this clinical trial studying?

A study testing Emotional freedom technique in people with Premenstrual Syndrome and Emotional Problem, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Units of Experience- (SUE) (time frame: Each participant will be evaluated for 1 week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.

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