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EFFECT OF EMOTIONAL FREEDOM TECHNIQUE ON PREMENSTRUAL SYNDROME

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EFT
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Emotional Regulation, Premenstrual Syndrome

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

EFT will be applied to individuals with premenstrual syndrome.

Individuals in the control group will not be interfered with.

Outcomes

Primary Outcome Measures

premenstrual syndrome and emotional freedom technique
This outcome is assessed with the premenstrual syndrome scale. The lower the score on the scale, the lower the premenstrual syndrome.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2023
Last Updated
September 11, 2023
Sponsor
KTO Karatay University
Collaborators
EMEL EGE, KAMİLE ALTUNTUĞ, Merve YAZAR
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1. Study Identification

Unique Protocol Identification Number
NCT06000579
Brief Title
EFFECT OF EMOTIONAL FREEDOM TECHNIQUE ON PREMENSTRUAL SYNDROME
Official Title
EFFECT OF EMOTIONAL FREEDOM TECHNIQUE ON PREMENSTRUAL SYNDROME: A RANDOMIZED CONTROLLED STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
September 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University
Collaborators
EMEL EGE, KAMİLE ALTUNTUĞ, Merve YAZAR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Emotional Regulation, Premenstrual Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
EFT will be applied to individuals with premenstrual syndrome.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Individuals in the control group will not be interfered with.
Intervention Type
Other
Intervention Name(s)
EFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
premenstrual syndrome and emotional freedom technique
Description
This outcome is assessed with the premenstrual syndrome scale. The lower the score on the scale, the lower the premenstrual syndrome.
Time Frame
3 month Wıll Be Followed.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Premenstrual syndrome is seen in women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MERVE YAZAR
Organizational Affiliation
merve.yazar@karatay.edu.tr
Official's Role
Study Chair
Facility Information:
Facility Name
KTO Karatay University
City
Konya
ZIP/Postal Code
42000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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EFFECT OF EMOTIONAL FREEDOM TECHNIQUE ON PREMENSTRUAL SYNDROME

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