The Effect of Emotional Freedom Technique on Premenstrual Syndrome

Not Applicable

Completed

• Conditions: Premenstrual Syndrome; Nursing Caries; Emotional Freedom Technique

• Registration Number: NCT06557070
• Lead Sponsor: Dokuz Eylul University

Brief Summary

Introduction: Premenstrual Syndrome (PMS) is a condition that occurs in the luteal phase of the menstrual cycle and affects women's lives physically, psychologically and behaviorally, starting approximately five days before menstruation and decreasing spontaneously a few days later.

Purpose: This research is planned to examine the effect of the Emotional Freedom Technique on the experience of premenstrual syndrome and menstrual symptoms and the quality of life of nursing students with premenstrual syndrome.

Method: The research will be conducted with first, second, third and fourth year female students studying at Dokuz Eylül University Faculty of Nursing. Diagnostic information form, premenstrual syndrome scale, menstruation symptom scale, SF-12 quality of life scale and subjective danger units will be collected via Google form. SUD Scale will be applied. The research is designed with experimental and control groups, and it is found that a total of 70 female students are needed, 35 in the experimental group and 35 in the control group. PMSS analysis will be performed and students who score over 132 points and meet the inclusion criteria will be numbered in the order of filling out the survey, and randomization will be done using the "Random Sequence Generator" through www.random.org, which provides computer-assisted randomization, and experimental and control groups will be created. Simple randomization will be applied to keep the control and experimental groups equal. To ensure blinding in the study, randomization will be carried out by someone other than the researchers. A total of 8 sessions of Emotional Freedom Technique (EFT) will be applied to the experimental group, once a week. No application other than the scales will planned for the control group.

Detailed Description

Premenstrual Syndrome (PMS) is a condition that occurs during the luteal phase of the menstrual cycle and begins approximately five days before menstruation, subsiding spontaneously a few days later. It affects women's lives physically, psychologically, and behaviourally. PMS is a common health issue among menstruating women, with a has a global prevalence of 47.8%, while its prevalence in Turkey is 52.2%. Although the exact aetiology of PMS is unknown, it is thought to be influenced by factors such as excess or deficiency of oestrogen, aldosterone and renin-angiotensin imbalance, progesterone deficiency, and thyroid dysfunction.

The Emotional Freedom Technique (EFT) is used to improve conditions such as anger, sadness, anxiety, and depression, where the individual's physical or psychological awareness is focused on a specific issue. EFT is based on the existence of an energy system (meridian system) that surrounds the physical body like a network. It involves tapping, pressing, and stimulating selected acupuncture points, particularly on the head and upper body, using the fingertips along these meridians. While applying pressure with the fingertips, a specific phrase related to the problem is recited. Each point is tapped at least seven times. Completing the specific phrase and taps is called an 'EFT round'.

A review of the literature reveals that PMS and its symptoms negatively impact women's lives in physical, psychological, and behavioural terms. This negative impact is also thought to adversely affect the individual's comfort and reduce their quality of life. As a coping method, EFT is effective in managing symptoms due to its low cost, reliability, absence of side effects, and ease of self administration. According to Clond (2016), more studies are needed to determine the effectiveness and level of evidence of EFT. This need can be met by increasing the number of randomised controlled trials and meta-analyses. This need can be met by increasing the number of randomised controlled trials and meta-analyses. We anticipate that our study, which was initiated for this purpose, will contribute to both the literature and practice. Furthermore, a review of the literature reveals that education, acupressure, and yoga methods are commonly used in studies on coping with PMS. One RCT study using the EFT method was found, but there was a lack of clarity on issues such as on which day of the menstrual cycle EFT was started, who performed the application, and whether the students performed the application or not. Differences were also found between the scales used in that study and our study. In this study, our aim is to improve the quality of life of nursing students experiencing PMS by reducing their premenstrual syndrome and menstrual symptoms through the application of EFT.

Inclusion Criteria;

* Scoring 132 or above on the Premenstrual Syndrome Scale (achieving 50% of the scale's total points),

* Aged 18 years or older,

* With a menstrual cycle length within normal limits (every 21-35 days) for the past three months,

* Voluntarily participating in the study,

* Possessing a smartphone and internet access, female students were included.

Exclusion Criteria:

* Receiving psychiatric treatment,

* Having started antidepressants in the last three months,

* Using oral contraceptives were excluded from the study. The G.Power 3.1 programme was used to determine the numbers of the experimental and control groups for the study. The calculation was made by referring to the study by Bakır, Irmak Vural and Körpe (2021) and 35 experimental groups and 35 control groups, totalling 70 students, were calculated at 80% power and 95% confidence interval.

To prevent potential data loss, 80 female students who met the inclusion criteria were grouped into 40 experimental and 40 control groups.

In an experimental study, keeping losses below 10% or 15% is considered important in reducing bias, and it is emphasised that increasing the sample size is useful in controlling bias associated with losses.

The groups included in the study were divided into two groups: the experimental group and the control group. A simple random method was used to select participants for the study. The pre-test measurements of the participants to be included in the study were collected by the researchers, and an independent statistician assigned IDs and sequence numbers to the relevant individuals. The experimental and control groups were determined blindly by an independent statistician using a lottery. The randomisation results obtained using Randomizer.org . The students included in the study did not know which group they were in. Furthermore, the analysis of the study was conducted by an independent statistician. The study is registered on ClinicalTrials.gov (Id No: NCT06557070). The study was conducted according to the Updated Guidelines for Reporting Randomised Parallel Group Studies (Consolidated Standards of Reporting Trials-CONSORT).

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Primary Completion: 2025-01-17
• Study Completion: 2025-01-17
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Scoring over 132 on the premenstrual syndrome scale
• Over 18 years old
• Having had a regular menstrual cycle for the last three months (21-35)
• Owner of a smartphone and internet
• Agreeing to participate in the research

Exclusion Criteria

• Psychiatric treatment and antidepressant medication in the last three months who have started,
• Who are pregnant,
• Who have given birth,
• Who use oral contraceptives,
• Who have difficulty accessing the internet
• Who did not participate in the post-test will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Personal Information Form	Before the EFT application	The Personal Information Form is a form consisting of 22 questions regarding socio-demographic characteristics, lifestyle and menstrual history, created by the researcher using the relevant literature in order to obtain the data of the female students to be included in the research and to perform randomization effectively.

Secondary Outcome Measures

Name	Time	Method
Premenstrual Syndrome Scale (PMSS)	Before and 3 months after the EFT application trial	It is a scale that aims to describe premenstrual symptoms and measure the severity of symptoms. Answers to the items on the scale are marked taking into account the situation of "being within the week before menstruation" as stated in the instructions. Scale, depressive affect , anxiety , fatigue , irritability , depressive thoughts , pain , appetite changes , It consists of nine subscales: sleep changes and bloating . The scale score is determined by the score obtained from the sub-dimensions. This score is called the "PMSÖ total score" and the lowest score that can be obtained is 44 and the highest score is 220. Increasing the scale score means increasing symptoms.

Trial Locations

Locations (1)

Dokuz Eylul University Faculty of Nursing; Izmir, İzmir, Turkey (Türkiye)