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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Visual Analog Scale for Fatigue
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Emotional Freedom Technique (Behavioral)
Control
Participants in the control group will not receive any intervention during the study period.
结局指标
主要结局
Visual Analog Scale for Fatigue
时间窗: 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.
Beck Hopelessness Scale
时间窗: 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.
Infertility Stigma Scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Aslı SİS ÇELİK
Professor
Ataturk University