Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-06-11
Brief Title:
The Effect of Emotional Freedom Technique EFT on Pain Intensity and Menstruation Symptoms
Sponsor:
Gulay Coskun
Organization:
Mersin University
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFT
Brief Summary:
The most important indicator of the fertility period which has an important place in a womans 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 23 PD is the most common womens health problem especially in adolescents and young adults 10-20 years of age 15
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 womens 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 stroketouch 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
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 womens 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 stroketouch 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
Detailed Description:
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 ClinicalTrialsgov 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
Location and Features of the Research The research is planned to be carried out in a high school providing secondary education in Ankara After obtaining the approval of the ethics committee a list of public high schools located in nine central districts of Ankara Provincial Directorate of National Education Altındağ Çankaya Etimesgut Gölbaşı Keçiören Mamak Pursaklar Sincan and Yenimahalle will be created and a high school will be determined by simple random sampling method It is planned to hold an information meeting in the conference hall of the high school to be determined
Students will be taught the EFT application in the meeting room or empty classroom within the high school In the first second and third cycles students will be able to do their applications at school lunch breakafter school or at home by determining the days and hours suitable for them under the control of the researcher
Identification of Participants In order to determine the participants in the research an information meeting about the research will be held in the conference hall of the school for female students between the ages of 14-17 who are studying at high school At the end of the meeting a list of students who volunteered to participate in the research will be made These students will be given informed voluntary consent forms for both themselves and their legal representatives to sign The next day the signed documents will be taken by going to the school A Compliance Determination Form will then be applied to identify students who experience primary dysmenorrhea in other words pain during menstrual periods Accordingly students with a menstrual pain severity of at least 4 according to the Visual Pain Scale a score of 60 or higher on the Menstruation Symptom Scale and meeting other selection criteria will be selected for inclusion in the study
Randomization 48 students from the 9th 10th and 11th grades of the high school will be included in the study First of all the number of students entering each stratum will be determined according to the stratified random sampling method Then in the assignment process of the students to be taken from these classes to the experimental and control groups block randomization will be applied in order to eliminate the selection bias and to keep the number of individuals between the groups in balance
blinding In the research EFT will not be blinded as it will be done face to face by the researcher However the participants will practice and be blinded without knowing whether they are in the study group or the control group Thus the research will be carried out as a single-blind randomized controlled trial When the research is completed the data of the study EFT and control groups coded as A or B will be transferred to the computer environment by an independent researcher and the data will be analyzed by a statistician and the findings will be reported
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 ClinicalTrialsgov 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
Location and Features of the Research The research is planned to be carried out in a high school providing secondary education in Ankara After obtaining the approval of the ethics committee a list of public high schools located in nine central districts of Ankara Provincial Directorate of National Education Altındağ Çankaya Etimesgut Gölbaşı Keçiören Mamak Pursaklar Sincan and Yenimahalle will be created and a high school will be determined by simple random sampling method It is planned to hold an information meeting in the conference hall of the high school to be determined
Students will be taught the EFT application in the meeting room or empty classroom within the high school In the first second and third cycles students will be able to do their applications at school lunch breakafter school or at home by determining the days and hours suitable for them under the control of the researcher
Identification of Participants In order to determine the participants in the research an information meeting about the research will be held in the conference hall of the school for female students between the ages of 14-17 who are studying at high school At the end of the meeting a list of students who volunteered to participate in the research will be made These students will be given informed voluntary consent forms for both themselves and their legal representatives to sign The next day the signed documents will be taken by going to the school A Compliance Determination Form will then be applied to identify students who experience primary dysmenorrhea in other words pain during menstrual periods Accordingly students with a menstrual pain severity of at least 4 according to the Visual Pain Scale a score of 60 or higher on the Menstruation Symptom Scale and meeting other selection criteria will be selected for inclusion in the study
Randomization 48 students from the 9th 10th and 11th grades of the high school will be included in the study First of all the number of students entering each stratum will be determined according to the stratified random sampling method Then in the assignment process of the students to be taken from these classes to the experimental and control groups block randomization will be applied in order to eliminate the selection bias and to keep the number of individuals between the groups in balance
blinding In the research EFT will not be blinded as it will be done face to face by the researcher However the participants will practice and be blinded without knowing whether they are in the study group or the control group Thus the research will be carried out as a single-blind randomized controlled trial When the research is completed the data of the study EFT and control groups coded as A or B will be transferred to the computer environment by an independent researcher and the data will be analyzed by a statistician and the findings will be reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None