NCT06329466

Brief Summary

The most important indicator of the fertility period, which has an important place in a woman's life, is the menstrual cycle, which begins with menarche and continues until menopause. In this natural process that takes place every month physiologically, some women experience significant pain \[1\]. This condition, defined as dysmenorrhea (painful menstruation), is classified in two ways as primary dysmenorrhea (PD) and secondary dysmenorrhea (SD) \[2,3\]. PD is the most common women's health problem, especially in adolescents and young adults (10-20 years of age) \[1,5\]. When studies on the incidence and severity of primary dysmenorrhea are examined, the incidence of PD is seen at rates ranging from 40-90% \[5-8\]. The main goal of the treatment approach to PD, which negatively affects women's quality of life in many ways, is to relieve the woman by reducing the pain. Emotional Freedom Technique (EFT) is one of the non-pharmacological and integrated treatment methods for women with primary dysmenorrhea. This practice, which is also referred to as EFT stroke/touch in most sources, is based on expressing the problem by touching the energy meridian points of the body, as in acupuncture and acupressure. Considering the results of the studies, it can be said that EFT is effective in the management of pain and the negative effects caused by the restrictions in the life of the person (social and daily living activities, etc.) \[27-30\]. Thanks to EFT, it is thought that women will contribute to the reduction of the fear and anxiety of experiencing pain just before menstruation and the anxiety that their life will be limited due to this. Studies investigating the effect of EFT on pain have reported that it is effective in coping with pain \[33-35\]. However, no randomized controlled study was found in the literature search for the application of EFT in high school students with dysmenorrhea. For this reason, it is thought that if EFT is applied in this age period with a high incidence of dysmenorrhea, important findings can be achieved in terms of parameters such as pain intensity and menstrual symptoms, and it will contribute to the literature by shedding light on similar studies. \[36\]. Therefore, in this study, it was aimed to determine the effect of the emotional freedom technique applied to high school students with primary dysmenorrhea on pain severity and menstruation symptoms.

Trial Health

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Trial Health Score

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Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 28, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2.4 years

First QC Date

June 11, 2023

Last Update Submit

March 23, 2024

Conditions

Keywords

Dysmenorrhea PrimaryEmotional Freedom Techniques (EFT)

Outcome Measures

Primary Outcomes (3)

  • Mcgill Pain Scale

    Mcgill Pain Scale Short Form (MAS-SF) The Mcgill Pain Scale Short Form was developed by Ronald Melzack in 1987 to determine the nature, effect, and overall pain intensity of pain \[41\]. In the first part of the Mcgill Pain Scale Short Form, there are 15 word groups describing the sensory/perceptual pain dimension (first 11 words) and emotional/emotional pain dimension (last four words). In the second part of the scale, the severity of the pain at that moment is determined from the patient by using the VAS. In the third part of the scale, a six-point Likert type scale is used to determine the general pain intensity. Scale; It consists of expressive values ranging from 0 = no pain, 1 = mild, 2 = bothersome, 3 = distressing, 4 = terrible, 5 = unbearable pain.

    Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

  • Menstruation Symptom Scale

    Menstruation Symptom Scale (MSI) It was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms \[43\]. The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009 by re-evaluating its factor structure and usability. The MSÖ score is calculated by taking the total mean score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The score obtained from the sub-dimensions in the scale is calculated by taking the total score average of the items in the sub-dimensions. An increase in the mean score for the sub-dimensions indicates an increase in the severity of menstrual symptoms related to that sub-dimension \[45\]. The highest value of the scale is 110 (menstrual problems most) and the lowest value is 22 (menstrual problems least).

    Before the study (Pre-test) 2. End of the application (week 12) 3. Post-test (at the end of the 16. week).

  • VAS pain scale

    Visual Analogue Scale (VAS) Different scales are used in studies to measure the level of pain. In our study, the pain intensity of the participants will be determined by using the Visual Analogue Scale (VAS) in the Determination of Compliance with the Criteria Form. VAS has been developed in order to be able to specify the severity of pain more easily by converting some values that cannot be measured numerically. VAS is a safe, easily applicable measurement tool that has been generally accepted in the world literature for many years. A low score on the VAS indicates low/low pain intensity, and a high score indicates high/severe pain \[39,40\]. The highest value of the scale is 10 (most pain) and the lowest value is 0 (no pain).

    Pre-Study will be applied to determine compliance with the criteria.

Study Arms (2)

Observation

Before starting the application to the adolescents in the study (EFT) group, researcher G.C. Fast and easy application steps will be explained with the demonstration method, supported by visual presentations. Care will be taken to provide a suitable, clean and airy environment in which the participants will feel comfortable. EFT training and applications will be held during the lunch break so that students do not experience problems such as being late for class or absenteeism. It will be taught in groups of 10-11 people in order to be sure that each participant has learned and to easily confirm the accuracy of the application. Researcher G.C. The participants will be asked to do it to themselves at the same time while they are doing it on themselves to teach the hitting points and application principles.

Other: intervention (EFT) group

Control

Students in the control group will not receive any intervention during the EFT application. Participants in the control group will have the MAÖKF and MSQ filled before the first session, at the end of the third cycle and at the end of the fourth cycle without the application. In order to eliminate ethical problems that may occur in the control group, EFT application will be taught to the participants in this group after the data collection process of the research is completed.

Other: intervention (EFT) group

Interventions

It is the group to which EFT is applied.

ControlObservation

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe female just have dysmenhorea
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The High School Female students with primary dysmenorrhea

You may qualify if:

  • between the ages of 14-17,
  • Willing to participate in the research,
  • Open to communication,
  • Having opportunities (computer, internet, etc.) to attend trainings online,
  • Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days),
  • Menstrual pain severity is at least 4 according to the Visual Pain Scale,
  • A score of 60 or more on the Menstruation Symptom Scale,
  • Applying to the obstetrician due to menstrual pain and determined not to have a pathology causing secondary dysmenorrhea,
  • Not using hormonal contraception,
  • Does not have a systemic and chronic disease,
  • EFT will block/limit the application no physical/mental health problems,
  • No psychiatric problems
  • Female students with primary dysmenorrhea studying in the 9th, 10th and 11th grades.

You may not qualify if:

  • under 14 years old and over 17 years old,
  • Those who do not agree to participate in the research,
  • Unable to communicate
  • Do not have opportunities (computer, internet, etc.) to attend trainings online,
  • Not having a regular menstrual period,
  • Menstrual pain severity is less than 4 according to the Visual Pain Scale,
  • A score of 59 or less on the Menstruation Symptom Scale,
  • Applying to the obstetrician due to menstrual pain and determined to have a pathology causing secondary dysmenorrhea,
  • Using hormonal contraception,
  • Having a systemic and chronic disease,
  • EFT will block/limit the application have physical/mental health problems,
  • Having a psychiatric problem,
  • th grade female students without primary dysmenorrhea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Yenişehir, Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Interventions

MethodsPopulation Groups

Intervention Hierarchy (Ancestors)

Investigative TechniquesDemographyPopulation Characteristics

Study Officials

  • Duygu Vefikuluçay Yılmaz, Prof

    Mersin University Faculty of Nursing

    STUDY CHAIR
  • Gülay Coşkun

    Mersin University Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MersinU

Study Record Dates

First Submitted

June 11, 2023

First Posted

March 26, 2024

Study Start

January 28, 2022

Primary Completion

June 25, 2024

Study Completion

July 25, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations