Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Web-Based Mind-Body Based Awareness Program.
- Кому может быть актуально
- Состояния в реестре: Infertility, Female. Базовые параметры: 23 лет — 45 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
Обзор
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.
Подробное описание
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 (Kıyak and Koçoğlu-Tanyer, 2021), 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 findings reported in Kıyak and Koçoğlu-Tanyer (2021) and anticipating a potential decline in progression from chemical pregnancy to clinical pregnancy, as well as possible losses inherent in the IVF treatment process, the sample size was increased 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.
The data collection instruments will include a Demographic Information Form, the Fertility Awareness Scale, and the Fertility Readiness Scale.
Within the scope of the study, a web-based mind-body awareness program based on Meleis Transition Theory will be applied to the women in the intervention group. The control group will receive routine nursing care provided in the unit.
The research data will be analyzed using mean, standard deviation, median, quartiles, percentages, minimum and maximum values, as well as Chi-square and Mann-Whitney U tests.
Вмешательства
- Другое Web-Based Mind-Body Based Awareness Program
The program was developed in accordance with peer-reviewed literature and expert opinions. A nursing approach based on Meleis Transition Theory will include education, mind-body awareness practices, and messages specific to women's health. Participants will take part in a five-session awareness program lasting approximately two weeks. Participants will be asked to complete their first final assessment one day after the oocyte pick-up (OPU) procedure, which corresponds to approximately 8-12 days
Первичные конечные точки
- Fertility Awareness Scale [Срок оценки: 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.]
- Fertility Preparedness Scale for Women Receiving Fertility Treatment [Срок оценки: 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.]
Вторичные конечные точки (1)
- Introductory Information Form [Срок оценки: 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.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Turkey (Türkiye) · 1 центр
- Hacettepe University — Ankara
Идентификаторы
NCT: NCT06585137 · PhD-01