Clinical trial NCT05358392: "Effect of Emotional Freedom Technique "
Official title: "Effect of Emotional Freedom Technique Application on Infertility Stress in Women"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotions
Infertility
Stress
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: INFERTILITY STRESS SCALE score
timeFrame: change from baseline ınfertility stress scale score ( approximately 15 days later ınfertility treatment)
Secondary outcomes:
measure: Subjective Level of Discomfort
timeFrame: 1,2,3,4,5. times EFT ıntervention (First 15 days of ınfertility treatment)
measure: pregnancy status (positive or negativity according to BHCG value)
timeFrame: 30 days later of ınfertility treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gonca Karataş Baran
state: Eyalet/Yerleşke
Study officials:
affiliation: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
name: GONCA K KARATAS BARAN, PHD
role: PRINCIPAL_INVESTIGATOR
References: