NCT06557070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

July 19, 2024

Last Update Submit

August 29, 2025

Conditions

Keywords

Premenstrual Syndromemenstrual symptomlife qualityemotional freedom techniqueNursing Care

Outcome Measures

Primary Outcomes (1)

  • Personal Information Form

    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.

    Before the EFT application

Secondary Outcomes (1)

  • Premenstrual Syndrome Scale (PMSS)

    Before and 3 months after the EFT application trial

Other Outcomes (2)

  • Menstruation Symptom Scale (MSS)

    Before and 3 months after the EFT application trial

  • Subjective Units of Distress Scale (SUDS)

    Before and 3 months after the EFT application trial

Study Arms (2)

Emotional Freedom Technique (EFT) experimental group

EXPERIMENTAL

A total of 8 sessions of Emotional Freedom Technique (EFT) will be applied to the experimental group, once a week. First, the experimental group was informed about premenstrual syndrome and EFT face to face and EFT application was taught. EFT application was performed every week for 2 cycles. During the application, plans were made to be face-to-face, online, in a group or individually. The posttest was repeated after the application was completed.

Other: The Emotional Freedom Technique

The control group.

NO INTERVENTION

The control group was first given a pre-test, then given information about premenstrual syndrome face to face, no intervention was made, they were asked not to use painkillers, a post-test was performed at the end of 2 cycles, and EFT was taught to the students who wanted it.

Interventions

Emotional freedom technique (EFT) is a method to help manage emotions and troubling thoughts and lower stress and anxiety. EFT is applying by tapping. To do EFT, you tap your fingertips on certain points on your hand, head, and torso which are used in acupuncture.

Emotional Freedom Technique (EFT) experimental group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenstrual syndrome is a disorder that affects women and especially adolescent girls, reducing their quality of life and negatively affecting their educational achievement and work life. Reducing these symptoms is a positive attempt to empower women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Faculty of Nursing

Izmir, İzmir, 35140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hande Yagcan, Assoc Prof

    Dokuz Eylul University Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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. Only, the control group will be taught the EFT technique at the end of the experiment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A single-blind randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 16, 2024

Study Start

November 1, 2023

Primary Completion

January 17, 2025

Study Completion

January 17, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations