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"Effect of Emotional Freedom Technique " ((EFT))

Primary Purpose

Emotions, Infertility, Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
emotional freedom technique (EFT)
Sponsored by
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Emotions

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:(For the intervention and control group):

  • Women who have applied to the IVF clinic for primary infertility treatment,
  • in the initial stage of IVF/ICSI treatment,
  • literate in Turkish,
  • have no chronic disease,
  • have no diagnosed psychiatric disease,
  • between the ages of 18-40,
  • agree to participate in the study.

Exclusion Criteria:

  • Women with a diagnosis of secondary infertility who do not meet the conditions for inclusion in the study (for the intervention and control group),
  • Women want to leave the study (for the intervention group) before the implementation phases are completed.

Sites / Locations

  • Gonca Karataş Baran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

emotional freedom technique

control

Arm Description

5 sessions of EFT* will be applied to this group on the first day of the treatment, 1st Control, 2nd Control, before the OPU procedure and before the embryo transfer. Subjective discomfort level will be measured with SUD** before and after each application.

No application will be made to this group. Infertility stress scale will be filled in the case and control group at the beginning of the treatment and after the embryo transfer.

Outcomes

Primary Outcome Measures

INFERTILITY STRESS SCALE score
This scale, which will be applied to evaluate the stress experienced by infertile women.The scale has three sub-dimensions related to "personal", "marriage" and "social" fields and consists of 14 items in total.

Secondary Outcome Measures

Subjective Level of Discomfort
It is the subjective rating of discomfort felt by the patient. Before starting the application in energy therapies, it is requested to evaluate the severity of the discomfort caused by the problem on a graded measurement called Subjective Units of Disturbance-SUD, which was used by Wolpe before. During this subjective evaluation, the client considers the discomfort he feels as 10 unbearable discomfort, 0 no discomfort, and scores it on a scale of 0-10. By means of this scoring, the severity of the discomfort felt by the individual at that moment is determined.
pregnancy status (positive or negativity according to BHCG value)
BHCG value evaluation in the blood (routinely applied in those who have ınfertility treatment)

Full Information

First Posted
April 21, 2022
Last Updated
September 7, 2023
Sponsor
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05358392
Brief Title
"Effect of Emotional Freedom Technique "
Acronym
(EFT)
Official Title
"Effect of Emotional Freedom Technique Application on Infertility Stress in Women"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will be conducted to investigate the effect of Emotional Freedom Technique (EFT) Application on infertility stress in women undergoing infertility treatment.
Detailed Description
Emotional Freedom Technique (EFT) is an easy-to-apply therapy, one of the types of energy psychotherapy. EFT gives effective and successful results in clinical problems. Personal energy level and balance are very important, as Gary Craig, the inventor of the technique, stated, "The cause of all negative emotions is due to the disorder in the body's energy system." Because any disruption or blockage in the energy flow brings with it physical and psychological disorders. For this reason, first of all, the negative emotion that causes the negative situation should be eliminated. When the energy flow in the meridians is balanced, the emotional intensity or negative/negative emotion also disappears. Thus, the person starts to feel good. In energy psychology applications, while the individual is in a relaxed and relaxed state, the electrical energy flow in the meridian system is also comfortable and regular. Emotional reactions such as anger, sadness, stress, disappointment create sudden obstacles in this flow. By focusing on the emotional reactions that hinder the individual, the stimulations on the meridian system (often by touch) regulate the energy flow and provide the individual to relax. The fact that the flow in the meridian system is not interrupted provides relief in the mind, body and emotion areas of the individual. EFT works on the cognitive and energetic levels. While it is ensured that the individual is conscious and aware of a disturbing symptom or disorder, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release. EFT is applied safely for stress management. It can be safely applied to individuals of all ages, including the elderly, pregnant and children. EFT was applied in 51 studies, 18 of which were randomized controlled and positive results were obtained with clinical measurements. With EFT, the energy flow can be regulated safely and consciously, contributing to the individual's "better" feeling. Positive results in past applications reveal the reliability of the method. Since the application procedure is easy, the application areas are versatile and it does not show side effects, it is recommended that EFT be widespread in different clinical areas and evidence-based studies should be increased.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotions, Infertility, Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Since there is no reference study on this subject, the effect width will be calculated for the main research question by making a preliminary application (9 cases, 9 controls) and the sample will be calculated with 90 power and 0.05 margin of error in the effect width obtained. Block randomization (3 blocks as male infertility, female infertility and unexplained infertility) for the pre-application intervention and control groups was performed through the Randomization Sofcare Allocation program. In the main application, this program will be made according to the number of samples and the intervention and control groups will be assigned. Pre-application data will be included in the research analysis. The Patient Follow-up Form consists of 3 parts. In the first part, there are data on socio-demographic and obstetric characteristics. The second part includes the infertility stress scale (pre-test) and the third part includes the infertility stress scale (post-test).
Masking
Participant
Masking Description
: Women who applied to Etlik Zübeyde Hanım Gynecology Training and Research Hospital IVF/ICSI unit for IVF/ICSI treatment. who meet the criteria for inclusion in the study will be informed about the study, and the women who accept the study will be assigned to the groups determined by randomization.After participating in the study, the participants will know which group they are in.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
emotional freedom technique
Arm Type
Experimental
Arm Description
5 sessions of EFT* will be applied to this group on the first day of the treatment, 1st Control, 2nd Control, before the OPU procedure and before the embryo transfer. Subjective discomfort level will be measured with SUD** before and after each application.
Arm Title
control
Arm Type
No Intervention
Arm Description
No application will be made to this group. Infertility stress scale will be filled in the case and control group at the beginning of the treatment and after the embryo transfer.
Intervention Type
Other
Intervention Name(s)
emotional freedom technique (EFT)
Intervention Description
EFT is an energy psychotherapy derivative application, consisting of cognitive and somatic components, used to heal personal negative emotions and related emotional and physical disorders. Stress hormones are secreted in response to the stress response in the person, and then the amygdala and other cerebral parts that respond to stress are activated. There are basic steps to be followed in EFT application; By giving a message to the emotional body (subconscious) with suggestion sentences, clicks are made on the twelve energy meridian endpoints (acupressure points).
Primary Outcome Measure Information:
Title
INFERTILITY STRESS SCALE score
Description
This scale, which will be applied to evaluate the stress experienced by infertile women.The scale has three sub-dimensions related to "personal", "marriage" and "social" fields and consists of 14 items in total.
Time Frame
change from baseline ınfertility stress scale score ( approximately 15 days later ınfertility treatment)
Secondary Outcome Measure Information:
Title
Subjective Level of Discomfort
Description
It is the subjective rating of discomfort felt by the patient. Before starting the application in energy therapies, it is requested to evaluate the severity of the discomfort caused by the problem on a graded measurement called Subjective Units of Disturbance-SUD, which was used by Wolpe before. During this subjective evaluation, the client considers the discomfort he feels as 10 unbearable discomfort, 0 no discomfort, and scores it on a scale of 0-10. By means of this scoring, the severity of the discomfort felt by the individual at that moment is determined.
Time Frame
1,2,3,4,5. times EFT ıntervention (First 15 days of ınfertility treatment)
Title
pregnancy status (positive or negativity according to BHCG value)
Description
BHCG value evaluation in the blood (routinely applied in those who have ınfertility treatment)
Time Frame
30 days later of ınfertility treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:(For the intervention and control group): Women who have applied to the IVF clinic for primary infertility treatment, in the initial stage of IVF/ICSI treatment, literate in Turkish, have no chronic disease, have no diagnosed psychiatric disease, between the ages of 18-40, agree to participate in the study. Exclusion Criteria: Women with a diagnosis of secondary infertility who do not meet the conditions for inclusion in the study (for the intervention and control group), Women want to leave the study (for the intervention group) before the implementation phases are completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GONCA K KARATAS BARAN, PHD
Organizational Affiliation
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gonca Karataş Baran
City
Ankara
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
06290
Country
Turkey

12. IPD Sharing Statement

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"Effect of Emotional Freedom Technique "

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