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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Premenstrual Syndrome, Emotional Problem
- 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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: Emotional freedom technique |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem GUVEN Santur, Inonu University
- Investigators
- Zeliha OZSAHİN, PhD, Study director, https://www.inonu.edu.tr/akademik/zeliha.ozsahinYeşim AKSOY DERYA, PhD, Study chair, https://www.inonu.edu.tr/akademik/yesim.aksoyÇiğdem KARAKAYALI AY, PhD, Study chair, https://saglikbilimleri.ozal.edu.tr/?page_id=7732
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).
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique on Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT05499000
- Acronym / sponsor ID
- Faculty of Health Science
- Conditions
- Premenstrual Syndrome, Emotional Problem
- Keywords
- Emotional Freedom Technique, Premenstruel Sendrom, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Emotional freedom techniqueEmotional 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Willingness to leave during research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional freedom techniqueEmotional 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. | Behavioural | Experimental group |
Primary outcome
Subjective Units of Experience- (SUE)
Time frame: Each participant will be evaluated for 1 week.
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.
2 secondary outcomes
Descriptive Data- (KBF)
Time frame: It will be obtained in 1 week at the beginning of the research.
Premenstrual Syndrome Scale- (PMSS)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No. Data will be obtained by Personal Information Form, Subjective Experience Units (SUE), Premenstrual Syndrome Scale (PMSS).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha OZSAHİN, PhD study director
https://www.inonu.edu.tr/akademik/zeliha.ozsahin
Yeşim AKSOY DERYA, PhD study chair
https://www.inonu.edu.tr/akademik/yesim.aksoy
Çiğdem KARAKAYALI AY, PhD study chair
https://saglikbilimleri.ozal.edu.tr/?page_id=7732
1 site in 1 country: see every site and its status.
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.