NCT07477665

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Feb 2026Dec 2026

Study Start

First participant enrolled

February 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 13, 2026

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale for Fatigue

    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

    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

    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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Emotional Freedom Technique

Control

NO INTERVENTION

Participants in the control group will not receive any intervention during the study period.

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 17, 2026

Study Start

February 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share