NCT06307236

Brief Summary

The aim of the study is to determine the effect of EFT application on the level of dysmenorrhea and stress perception in women with dysmenorrhea. For this purpose, EFT will be applied to women with dysmenorrhea with high stress perception assigned to the experimental and control groups, and their stress perceptions and dysmenorrhea levels will be re-evaluated after the application. Perceived Stress Scale (PSS) and Visual Analog Scale (VAS) will be used in the research.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

February 27, 2024

Last Update Submit

March 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • EFT application

    Perceived stress scale, VAS

    12 weeks

  • Control

    Perceived stress scale, VAS

    12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Group to be applied EFT

Behavioral: Emotional Freedom Techniques

Control

NO INTERVENTION

No application will be made

Interventions

Emotional Freedom Technique (EFT), which is included in the energy psychotherapy similar to the cognitive behavioral therapy method, is an easily applicable method that is used to relieve mental problems such as anxiety and stress and has positive results, which has just started to be used in the world and in our country. EFT can be applied safely to all ages and groups.

Experimental

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince dysmenorrhea is seen only in women, our study will be conducted with women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be between 18-49 years old and single,
  • Must be literate and willing to participate in the study,
  • There should be no wounds, scars or infections in the area where EFT will be applied.
  • The perceived stress level must be high and they must be experiencing dysmenorrhea

You may not qualify if:

  • There should be no change in menstrual cycle in the last six months,
  • There must be no communication problems or illnesses that may prevent work.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

Study Officials

  • Elif Tuğçe ÇİTİL

    Kütahya Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 12, 2024

Study Start

December 15, 2023

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations