Emotions(EFT)NCT05358392
"Effect of Emotional Freedom Technique "
A study testing emotional freedom technique (EFT) in people with Emotions and Infertility, run by Gonca Karatas Baran at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to investigate the effect of Emotional Freedom Technique (EFT) Application on infertility stress in women undergoing infertility treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotions, Infertility, Stress
- What is being tested?
- emotional freedom technique (EFT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gonca Karataş Baran
Ankara, Eyalet/Yerleşke, 06290
About this study
Official title: "Effect of Emotional Freedom Technique Application on Infertility Stress in Women"
This study will be conducted to investigate the effect of Emotional Freedom Technique (EFT) Application on infertility stress in women undergoing infertility treatment.
Read the 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.
- Conditions
- Emotions, Infertility, Stress
- Being tested
- emotional freedom technique (EFT)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional freedom technique (EFT)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| emotional freedom technique | Experimental | 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. Receives: Other: emotional freedom technique (EFT) |
| control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline ınfertility stress scale score ( approximately 15 days later ınfertility treatment)
Secondary outcomes (2)
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.
Measured: 1,2,3,4,5. times EFT ıntervention (First 15 days of ınfertility treatment)
pregnancy status (positive or negativity according to BHCG value)
BHCG value evaluation in the blood (routinely applied in those who have ınfertility treatment)
Measured: 30 days later of ınfertility treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 May 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonca Karatas Baran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gonca Karatas Baran, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- GONCA K KARATAS BARAN, PHD, Principal investigator, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358392
- Sponsor's protocol ID
- Etlik SagBakHizm
- Acronym
- (EFT)
- Status last verified
- Nov 2024
- First submitted
- 21 Apr 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Emotional Freedom Technique Application on Infertility Stress in Women"
- ClinicalTrials.gov ID
- NCT05358392
- Acronym / sponsor ID
- (EFT) / Etlik SagBakHizm
- Conditions
- Emotions, Infertility, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Gonca Karatas BaranUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| emotional freedom technique | Experimental | Other: emotional freedom technique (EFT)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. |
| control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emotional freedom technique (EFT)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). | Other | emotional freedom technique |
Primary outcome
INFERTILITY STRESS SCALE score
Time frame: change from baseline ınfertility stress scale score ( approximately 15 days later ınfertility treatment)
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.
2 secondary outcomes
Subjective Level of Discomfort
Time frame: 1,2,3,4,5. times EFT ıntervention (First 15 days of ınfertility treatment)
pregnancy status (positive or negativity according to BHCG value)
Time frame: 30 days later of ınfertility treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Related trials for Emotions
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Active, not recruiting
The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol
Autism, Sleep Disturbance
Not yet recruitingPhase 2
Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism
Autism in Children, Autistic Disorder in Children and Adolescents
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GONCA K KARATAS BARAN, PHD principal investigator
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional freedom technique (EFT) in people with Emotions and Infertility, run by Gonca Karatas Baran at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INFERTILITY STRESS SCALE score (time frame: change from baseline ınfertility stress scale score ( approximately 15 days later ınfertility treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.