- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477665
Effect of Emotional Freedom Techniques on Fatigue, Hopelessness, and Perceived Stigma in Women With Unsuccessful IVF Experience
The Effect of Emotional Freedom Techniques Based on Levine's Conservation Model on Fatigue, Hopelessness, and Perceived Stigma in Women With Unsuccessful IVF Experience: A Randomized Controlled Trial
In this study, it is planned to provide nursing care to women with an experience of unsuccessful IVF treatment by combining Emotional Freedom Technique (EFT) with the principles developed in line with the philosophy of Levine's Conservation Model. Women with an experience of unsuccessful IVF treatment will be evaluated according to the three conservation principles, and these principles will form the basis of the setup statements used in the EFT sessions. When evaluated within the scope of the model, infertility disrupts the individual's energy conservation, leading to increased fatigue; impairs personal integrity, causing feelings of hopelessness; and threatens social integrity, resulting in feelings of stigma and isolation. In line with the integrity principles emphasized in Levine's model, it is considered that EFT may reduce fatigue by regulating the disrupted energy balance, alleviate levels of hopelessness by supporting personal integrity, and reduce the effects of infertility-related stigma by strengthening social integrity.
In this context, this study will be conducted to examine the effects of Emotional Freedom Techniques (EFT), structured in accordance with Levine's Conservation Model, on levels of fatigue, hopelessness, and perceived stigma in women with an experience of unsuccessful IVF treatment. This study will be conducted with 80 women who have experienced unsuccessful IVF treatment and meet the inclusion criteria of the study, including 40 women in the experimental group and 40 women in the control group, at Atatürk University Research Hospital In Vitro Fertilization Center. In the study, pre-test data of women in the experimental and control groups assigned through randomization will be collected using the Participant Information Form, the Visual Analog Scale for Fatigue, the Beck Hopelessness Scale, and the Infertility Stigma Scale. EFT structured in line with Levine's Conservation Model will be applied to the women in the experimental group, while no intervention will be applied to the control group. Post-test data will be collected from women in both the experimental and control groups after the completion of the 4-week EFT sessions. In order to test the effectiveness of EFT over time, repeated measurements will be conducted one month after the last application for each participant, and women in the experimental and control groups will complete the Visual Analog Scale for Fatigue, the Beck Hopelessness Scale, and the Infertility Stigma Scale again. The data of the experimental and control groups, coded as X and Y, will be transferred to a computer environment by an independent statistician, and the data will be analyzed and the findings will be reported.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged between 18 and 45 years,
- Having experienced at least one unsuccessful IVF treatment,
- Able to read and write in Turkish,
- Having no hearing or visual impairment,
- Having no diagnosis of a psychiatric disorder,
- Not using any complementary and alternative therapy methods (such as Reiki, hypnofertility, or acupressure),
- Scoring 4 or higher on the Beck Hopelessness Scale,
- Residing in the province of Erzurum,
- Willing to participate in the study voluntarily.
Exclusion Criteria:
- Receiving any assisted reproductive treatment during the study period,
- Developing a healthy pregnancy after enrollment in the study,
- Being diagnosed with a psychiatric disorder after the start of the study,
- Initiating the use of any complementary and alternative therapy methods during the study period,
- Women who request to withdraw from the study will be excluded from the sample.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants in the experimental group will receive Emotional Freedom Techniques (EFT) structured in line with Levine's Conservation Model.
The intervention will be delivered over a 4-week period through EFT sessions developed according to the three conservation principles of the model.
|
Emotional Freedom Techniques (EFT) is a behavioral mind-body intervention that combines cognitive and somatic components.
In this study, EFT will be structured in line with Levine's Conservation Model and tailored according to the three conservation principles (energy, personal integrity, and social integrity).
The intervention will be delivered by a trained nurse through standardized EFT sessions conducted over a 4-week period.
Each session will include setup statements developed based on the participant's experiences related to unsuccessful IVF treatment and the corresponding conservation principles.
|
|
No Intervention: Control
Participants in the control group will not receive any intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for Fatigue
Time Frame: This form will be administered at baseline. The experimental group will receive EFT for 4 weeks. The form will be re-administered as a post-test after the intervention and as a follow-up test one month later.
|
The scale consists of 18 items.
Items 1, 2, 3, 4, 5, and 11 through 18 constitute the fatigue subscale, while items 6, 7, 8, 9, and 10 constitute the energy subscale.
The scale is presented in the form of a 10-cm visual ruler, with the most positive expression at one end and the most negative expression at the other.
For the fatigue subscale, the most positive expression is scored as 0 and the most negative expression as 10, whereas for the energy subscale, the most negative expression is scored as 0 and the most positive expression as 10.
Items in the fatigue subscale are ordered from the most positive to the most negative, while items in the energy subscale are ordered from the most negative to the most positive.
A higher score on the fatigue subscale and a lower score on the energy subscale indicate greater severity of fatigue.
|
This form will be administered at baseline. The experimental group will receive EFT for 4 weeks. The form will be re-administered as a post-test after the intervention and as a follow-up test one month later.
|
|
Beck Hopelessness Scale
Time Frame: This form will be administered at baseline. The experimental group will receive EFT for 4 weeks. The form will be re-administered as a post-test after the intervention and as a follow-up test one month later.
|
The scale consists of three subscales: Loss of Motivation, comprising 8 items (2, 4, 9, 12, 14, 16, 17, and 20); Feelings and Expectations About the Future, comprising 5 items (1, 3, 7, 11, and 18); and Hope, comprising 7 items (5, 6, 8, 10, 13, 15, and 19).
The total score obtainable from the scale ranges from 0 to 20.
Scoring is based on binary responses, with a score of 1 assigned for a "No" response on items 1, 3, 5, 6, 8, 10, 12, 13, 15, and 19, and for a "Yes" response on items 2, 4, 7, 9, 11, 14, 16, 17, 18, and 20.
The total score constitutes the participant's hopelessness score, with higher scores indicating greater levels of hopelessness.
Scores of 0-3 indicate no hopelessness, 4-8 indicate low hopelessness, 9-14 indicate moderate hopelessness, and 15-20 indicate high levels of hopelessness.
|
This form will be administered at baseline. The experimental group will receive EFT for 4 weeks. The form will be re-administered as a post-test after the intervention and as a follow-up test one month later.
|
|
Infertility Stigma Scale
Time Frame: This form will be administered at baseline. The experimental group will receive EFT for 4 weeks. The form will be re-administered as a post-test after the intervention and as a follow-up test one month later.
|
The Infertility Stigma Scale consists of 27 items rated on a 5-point Likert scale.
It includes four subscales: self-devaluation (7 items), social withdrawal (5 items), public stigma (9 items), and family stigma (6 items).
Total scores range from 27 to 135, with higher scores indicating greater perceived stigma.
|
This form will be administered at baseline. The experimental group will receive EFT for 4 weeks. The form will be re-administered as a post-test after the intervention and as a follow-up test one month later.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B.30.2.ATA.0.01.00/802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emotional Freedom Technique
-
Inonu UniversityRecruitingMental Well-being | Virtual Reality | Fear of Childbirth | Attachment | Emotional Freedom Technique | Primiparous Pregnant WomenTurkey
-
Necmettin Erbakan UniversityRecruitingEmotional Freedom Technique | Pre-Exam AnxietyTurkey
-
Yantai Yuhuangding HospitalCompletedAnxiety | Day Surgery | Preoperative Nursing Care | Emotional Freedom TechniqueChina
-
Kahramanmaras Sutcu Imam UniversityCompletedThe Effect of Emotional Freedom Technique on Anxiety, Pain, and Vital SignsTurkey (Türkiye)
-
Dokuz Eylul UniversityCompletedNursing Caries | Premenstrual Syndrome | Emotional Freedom TechniqueTurkey (Türkiye)
-
Saglik Bilimleri UniversitesiCompletedAnxiety | Emotional Freedom TechniquesTurkey (Türkiye)
-
Bitlis Eren UniversityCompletedComplementary Therapies | Bariatric Surgery | Kinesiophobia | Pressure Sore | Emotional Freedom TechniqueTurkey (Türkiye)
-
Ondokuz Mayıs UniversitySamsun Education and Research HospitalCompletedSurgery (Cardiac) | Coronary Arterial Disease (CAD) | Emotional Freedom TechniqueTurkey (Türkiye)
-
Kutahya Health Sciences UniversityEnrolling by invitationStress | Dysmenorrhea Primary | Emotional FreedomTurkey
-
Hatice BalcıNot yet recruitingCoronary Artery Bypass Graft (CABG) | Effects of Emotional Freedom Techniques (EFT)Turkey (Türkiye)
Clinical Trials on Emotional Freedom Technique
-
Bingol UniversityActive, not recruitingCesarean Section | Preoperative AnxietyTurkey (Türkiye)
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Soul Medicine InstituteCompletedStress Disorders, Post-TraumaticUnited States
-
Uşak UniversityRecruiting
-
Bitlis Eren UniversityCompletedAnxiety | Compliance, Patient | Complication,Postoperative | Limb Injury | Complication Diabetic | Limb IschemiaTurkey (Türkiye)
-
Inonu UniversityCompletedAnxiety | Nausea Gravidarum | Emotion Regulation | Vomiting of PregnancyTurkey
-
Saglik Bilimleri UniversitesiNot yet recruitingPreoperative Anxiety | Thyroid Surgery | Fear and AnxietyTurkey (Türkiye)
-
Marmara UniversityActive, not recruitingAnxiety | Nursing Caries | EFTsTurkey
-
Istanbul Saglik Bilimleri UniversityCompleted
-
Necmettin Erbakan UniversityRecruitingEmotional Freedom Technique | Pre-Exam AnxietyTurkey