NCT Number: NCT06585137
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.
Trial opening soon.
Get Notified23 year–45 year
Female
Interventional
Not applicable
Ankara, Samanpazarı, 06100, Turkey (Türkiye)
Gülşah VURAL AKTAN, Master of Science in Nursing
CONTACT
Gülşah VURAL AKTAN, Master of Science in Nursing
PRINCIPAL_INVESTIGATOR
Onur İNCE, MD
PRINCIPAL_INVESTIGATOR
Çiğdem YÜCEL ÖZÇIRPAN, PhD
CONTACT
Çiğdem YÜCEL ÖZÇIRPAN, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 after ovarian stimulation. No mind-body exercises will be requested between embryo transfer and the day of the pregnancy test. During this period, follow-up between the researcher and participants will continue, and nursing care based on Meleis' theory will be provided.
The implementation phase of the study will be completed after the second final assessment conducted one day before the pregnancy test, with at least the minimum required sample size achieved.
Time frame: 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''.
Time frame: 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.
Time frame: 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.
Follicle-stimulating hormone (FSH) and estradiol (E2) levels, number of oocytes collected, embryo transfer status, and blood pregnancy test results will be taken from the patient file and added to the form.
Contact information is provided by the study sponsor or research team.
Gülşah VURAL AKTAN, Master of Science of Nursing
CONTACT
Çiğdem YÜCEL ÖZÇIRPAN, PhD
CONTACT
Hacettepe University
Other
The Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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