- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000579
The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students
June 24, 2024 updated by: Hafize Dağ Tüzmen, KTO Karatay University
The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students: A Randomized Controlled
PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms.
The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan.
It was detected in the range of 92% in India and 14.3%-74.4% in India.
Common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes.
In addition to physical symptoms, studies indicate that individuals reporting PMS experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations.
Studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression.
It is thought that modulating many PMS symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future PMS interventions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Konya, Turkey, 42000
- KTO Karatay University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Persons with amenorrhea,
- pregnancy,
- menstrual irregularity,
- chronic disease,
- mental disorders,
- psychiatric disorders,
- polycystic ovarian syndrome,
- those who have received training on EFT before and those who have communication problems will not be included in the study.
Exclusion Criteria:
- Female students between the ages of 18-25,
- who scored 111 or higher on the Premenstrual Syndrome Scale (PMSS)
- participated in the study voluntarily will be included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
EFT will be applied to individuals with premenstrual syndrome.
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Each student will be asked to voluntarily give their phone number and last menstrual cycle date, and the day will be determined for the first session.
Then, the first EFT session will be made by the researchers by calling 14 days before the menstruation date.
In the 2nd and 3rd sessions, a total of 3 sessions of EFT will be applied face-to-face by the researchers 14 days before menstruation.
After each student completes three menstrual cycles, the researchers will meet with the student and PMSS will be applied as a post-test.
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No Intervention: Control Group
Individuals in the control group will not be interfered with.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
premenstrual syndrome and emotional freedom technique
Time Frame: 3 month Wıll Be Followed.
|
This outcome is assessed with the premenstrual syndrome scale.
The lower the score on the scale, the lower the premenstrual syndrome.
|
3 month Wıll Be Followed.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: MERVE YAZAR, merve.yazar@karatay.edu.tr
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2023
Primary Completion (Actual)
August 17, 2023
Study Completion (Actual)
September 11, 2023
Study Registration Dates
First Submitted
June 4, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 24, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MrvHfz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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