NCT05499000

Brief Summary

Objective: This study was conducted to evaluate the Effect of Emotional Freedom Technique on Premenstrual Syndrome. Methodology: The research will be conducted as a randomized controlled trial. The research will be carried out with students studying at the Department of Midwifery, Faculty of Health Sciences, İnönü University, between September and October 2022. The sample size of the study was calculated as 102 people with an effect size of 0.80 and a power of 0.95. Premenstrual syndrome scale will be applied to all students participating in the research first and those who score 110 and above will be listed. Experimental and control groups will be determined by randomization. Personal information form, subjective experience unit scale and premenstrual syndrome scale will be used to collect data. SPSS 22.0 package program will be used in the evaluation of the data. The independent variable of the research is the emotional liberation technique. The dependent variable of the study is the mean scores of the participants from the subjective experience unit scale and premenstrual syndrome scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

August 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

August 7, 2022

Last Update Submit

March 28, 2024

Conditions

Keywords

Emotional Freedom TechniquePremenstruel SendromMidwifery

Outcome Measures

Primary Outcomes (1)

  • Subjective Units of Experience- (SUE)

    The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables.

    Each participant will be evaluated for 1 week.

Secondary Outcomes (2)

  • Descriptive Data- (KBF)

    It will be obtained in 1 week at the beginning of the research.

  • Premenstrual Syndrome Scale- (PMSS)

    It will take an average of 1 month to obtain the data. Measured PMSS scale data will be reported within 2 weeks at the end of the study.

Study Arms (2)

Experimental group

EXPERIMENTAL

Emotional freedom technique will be applied online with the researcher in 2 sessions, 3 days apart. KBF, SUE, PMSS pre-tests will be applied before the intervention, SUE will be applied before and after each session, At the end of the second session, post-test data will be obtained with SUE, PMSS.

Behavioral: Emotional freedom technique

Control group

NO INTERVENTION

KBF, SUE and PMSS pre-tests will be applied to the participants, SUE, PMSS and post-test data will be obtained simultaneously with the experimental group.

Interventions

Emotional freedom technique will be applied online with the researcher in 2 sessions, 3 days apart. KBF, SUE, PMSS tests will be applied before the intervention, SUE will be applied before and after each session, At the end of the 2nd session, post-test data will be taken with SUE, PMSS.

Experimental group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be between 18-25,
  • Single,
  • Not to use anything pharmacological or non-pharmacological during the research,
  • Not having a diagnosed psychiatric disease such as epilepsy.

You may not qualify if:

  • Willingness to leave during research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Health Sciences

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zeliha OZSAHİN, PhD

    https://www.inonu.edu.tr/akademik/zeliha.ozsahin

    STUDY DIRECTOR
  • Yeşim AKSOY DERYA, PhD

    https://www.inonu.edu.tr/akademik/yesim.aksoy

    STUDY CHAIR
  • Çiğdem KARAKAYALI AY, PhD

    https://saglikbilimleri.ozal.edu.tr/?page_id=7732

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 12, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Data will be obtained by Personal Information Form, Subjective Experience Units (SUE), Premenstrual Syndrome Scale (PMSS).

Locations