NCT06000579

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 4, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 4, 2023

Last Update Submit

June 24, 2024

Conditions

Premenstrual Syndrome

Keywords

Emotional Regulation, Premenstrual Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 month Wıll Be Followed.

Study Arms (2)

Experimental Group

EXPERIMENTAL

EFT will be applied to individuals with premenstrual syndrome.

Other: EFT

Control Group

NO INTERVENTION

Individuals in the control group will not be interfered with.

Interventions

EFTOTHER

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.

Experimental Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenstrual syndrome is seen in women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeEmotional Regulation

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorBehavior

Study Officials

  • MERVE YAZAR

    merve.yazar@karatay.edu.tr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

June 4, 2023

First Posted

August 21, 2023

Study Start

July 15, 2023

Primary Completion

August 17, 2023

Study Completion

September 11, 2023

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)