The Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Fertility Awareness Scale
研究概览
简要总结
The goal of this two-group parallel randomized controlled study is to determine the effect of a web-based mind-body-based awareness program based on Meleis Transition Theory on fertility awareness and readiness levels in women receiving infertility treatment.
详细描述
Improving fertility awareness in women undergoing infertility treatment may facilitate changes in lifestyle behaviors that can enhance fertility. Increasing fertility awareness among infertile individuals may improve the likelihood of pregnancy and the chance of achieving a healthy pregnancy. It may also positively influence general health and reproductive health and support the modification of negative lifestyle behaviors that could affect the infertility treatment process. Fertility awareness may contribute to fertility readiness, which in turn may have a positive impact on treatment outcomes.
This study will be conducted as a two-group parallel randomized controlled trial to determine the effect of a web-based mind-body awareness program based on Meleis Transition Theory on fertility awareness and fertility readiness levels in women undergoing infertility treatment. The study will be carried out with women receiving infertility treatment at the In Vitro Fertilization Unit of Hacettepe University Faculty of Medicine.
The sample will consist of women who voluntarily agree to participate in the study, have initiated the infertility treatment process, have undergone a maximum of two IVF attempts, are able to speak and understand Turkish, have at least a primary school education, are not participating in any psychological or social support group, and have not completed or are not currently participating in any mind-body program related to fertility.
The sample size was determined in consultation with a statistician. Based on a review of the literature, particularly a study examining the effects of progressive muscle relaxation exercises on mental health and treatment outcomes in women undergoing IVF, a power analysis was conducted to determine the required sample size. The power analysis indicated that, for a power of 90%, a 95% confidence level, an effect size of f = 0.198, two groups (intervention and control), and three repeated measurements, a total sample size of 48 participants was required.
Considering the anticipated attrition resulting from the transition from chemical pregnancy to clinical pregnancy and the potential losses inherent in the IVF treatment process, the calculated sample size was inflated by 60%. Accordingly, the study sample was planned as 78 participants in total, with 39 in the intervention group and 39 in the control group. After randomization, no new participants will be added to replace those who withdraw or are excluded from the study for any reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Volunteering to participate in research
- •Being diagnosed with primary infertility
- •Starting the infertility treatment process
- •Having attempted IVF at most twice before
- •Being able to speak and understand Turkish
- •Being at least a primary school graduate
- •Not taking part in any psychological or social support group.
- •Not having completed or currently participating in any mind/body program for fertility.
排除标准
- •Women applying for frozen embryo transfer without ovarian stimulation
- •Being diagnosed with secondary infertility
- •Having a diagnosis of a chronic disease
- •Having communication problems (vision, hearing)
研究组 & 干预措施
Web-based mind-body awareness program
Participants in the intervention group will participate in a web-based mind-body awareness program.
干预措施: Web-Based Mind-Body Based Awareness Program (Other)
Routine nursing care
No intervention will be applied to the control group.
结局指标
主要结局
Fertility Awareness Scale
时间窗: A pre-test will be administered before the study begins. Then, a post-test will be administered three times, 1 day after the OPU procedure, then at 3 months and 6 months.
This scale was developed to measure fertility awareness in women. The scale is Likert-type and has 19 items and two sub-dimensions (Body Awareness, Cognitive Awareness). Items in the scale are scored from 1 to 5 (1-Never, 2-Rarely, 3-Occasionally, 4-Most of the time and 5-Always) and there are no reverse-scored items. Possible scores in total for the scale are 19-95, 10-50 for the "Body Awareness" sub-dimension, and 9-45 for the "Cognitive Awareness" sub-dimension. If the total score is between 19-43, the awareness level is interpreted as ''low'', if it is between 44-69, it is ''medium'', and if it is between 70-95, it is interpreted as ''high''.
Fertility Preparedness Scale for Women Receiving Fertility Treatment
时间窗: A pre-test will be administered before the study begins. Then, a post-test will be administered three times, 1 day after the OPU procedure, then at 3 months and 6 months.
The scale, consisting of 23 questions, was created to measure the readiness of women preparing to become pregnant. The scale consists of 3 sub-dimensions: "hope and awareness", "relaxed body and brain" and "positive feelings and thoughts". Since the scale items consist only of positive expressions, the scores obtained are calculated as they are. The scores of the items are 5, 4, 3, 2, and 1, respectively. The minimum score is 23, the maximum score is 115 on the scale, and a high score indicates that fertility preparedness is strong. The median score on the scale is 56. A score of 56 or higher on the scale indicates that the woman feels more prepared for pregnancy, while a lower score indicates that she feels less prepared.
Fertility Awareness Scale
时间窗: A pre-test will be administered before the study begins. Then, an interim test will be administered 1 day after the OPU procedure, followed by a final test one day before the pregnancy test.
This scale was developed to measure fertility awareness in women. The scale is Likert-type and has 19 items and two sub-dimensions (Body Awareness, Cognitive Awareness). Items in the scale are scored from 1 to 5 (1-Never, 2-Rarely, 3-Occasionally, 4-Most of the time and 5-Always) and there are no reverse-scored items. Possible scores in total for the scale are 19-95, 10-50 for the "Body Awareness" sub-dimension, and 9-45 for the "Cognitive Awareness" sub-dimension. If the total score is between 19-43, the awareness level is interpreted as ''low'', if it is between 44-69, it is ''medium'', and if it is between 70-95, it is interpreted as ''high''.
Fertility Preparedness Scale for Women Receiving Fertility Treatment
时间窗: A pretest will be administered before the study begins. Then, an interim test will be administered 1 day after the OPU procedure, followed by a final test to be conducted one day before the pregnancy test.
The scale, consisting of 23 questions, was created to measure the readiness of women preparing to become pregnant. The scale consists of 3 sub-dimensions: "hope and awareness", "relaxed body and brain" and "positive feelings and thoughts". Since the scale items consist only of positive expressions, the scores obtained are calculated as they are. The scores of the items are 5, 4, 3, 2, and 1, respectively. The minimum score is 23, the maximum score is 115 on the scale, and a high score indicates that fertility preparedness is strong. The median score on the scale is 56. A score of 56 or higher on the scale indicates that the woman feels more prepared for pregnancy, while a lower score indicates that she feels less prepared.
次要结局
- Introductory Information Form(FSH and E2 levels will be monitored on the 2nd-3rd day of the menstrual cycle, the number of oocytes collected on the 16th day of the cycle, embryo transfer status on the 18th day of the cycle, and pregnancy test on the 28th day of the cycle.)
研究者
Gülşah VURAL AKTAN
Nurse
Hacettepe University