跳至主要内容
临床试验/NCT06329466
NCT06329466进行中(未招募)不适用

The Effect of Emotional Freedom Technique (EFT) on Pain Intensity and Menstruation Symptoms in High School Students With Primary Dysmenorea: A Single Blind Randomized Control Study

Gulay Coskun1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
48
试验地点
1
主要终点
Menstruation Symptom Scale

研究概览

简要总结

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.

详细描述

Between 26 December 2022 and 26 June 2023, data will be collected from 48 female students who meet the inclusion and exclusion criteria. 9th, 10th and 11th grade female students in the randomized controlled experimental study, whose menstrual pain severity was less than 4, menstrual symptom score was 60 and above, who met all the other inclusion criteria of the study and who declared that they were willing to participate in the study. planned with. Permission approval will also be obtained from the parents of the students who volunteer. Whether or not female students experience primary dysmenorrhea in the study will be determined by the questions in the Determination of Conformity to the Criteria Form (Annex-1), which is the first part of the data collection form.

Purpose and Type of Research The study was planned as a prospective, single-blind randomized controlled experimental study to determine the effect of emotional freedom technique (EFT) on pain level and menstrual symptoms in high school students with primary dysmenorrhea. This randomized controlled trial will be reported according to CONSORT guidelines and registered on ClinicalTrials.gov [37].

The universe of the research; The population of the research will be female students between the ages of 14-17 at secondary schools in Ankara between 26 December 2022 and 25 June 2023.

The sample of the research; The sample of the study will consist of 48 female students aged 14-17 in a secondary school in Ankara between 26 December 2022 and 26 May 2023.

In order to determine the high school where the research will be conducted, public high schools located in the central districts of Ankara will be listed. A high school will be determined by simple random sampling method. The number of female students between the ages of 14-17 studying at the determined high school will be determined by the Stratified Sampling Method according to the class [38].

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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,
  • 12th grade female students without primary dysmenorrhea.

结局指标

主要结局

Menstruation Symptom Scale

时间窗: 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 (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).

VAS pain scale

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

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).

Mcgill Pain Scale

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

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.

次要结局

未报告次要终点

研究者

发起方
Gulay Coskun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gulay Coskun

MersinU

Mersin University

研究点 (1)

Loading locations...

相似试验