Clinical trial NCT06585137: Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment
Official title: Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility, Female
Keywords: Nursing
Infertility
Nursing Theory
Fertility
Awareness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 78
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Developing fertility awareness in women receiving infertility treatment can enable changes in lifestyle habits that can increase fertility. Having and increasing fertility awareness in infertile individuals can increase the likelihood of pregnancy and having a healthy pregnancy, positively affect general health and reproductive health, and change negative lifestyle habits that can affect the treatment process for infertility. Fertility readiness can be provided with fertility awareness and can positively affect treatment outcomes. This research 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 readiness levels in women receiving infertility treatment. The research will be conducted with women receiving infertility treatment at the In Vitro Fertilization Unit of Hacettepe University Faculty of Medicine. The sample will include women who volunteer to participate in the study, have started the infertility treatment process, have had at most two IVF attempts, speak and understand Turkish, are at least primary school graduates, are not in any psychological or social support group, have not completed or are not currently participating in any mind/body program for fertility. A total of 78 women will be included in the study sample: 39 for the intervention group and 39 for the control group. The Introductory Information Form, Fertility Awareness Scale, Fertility Readiness Scale, and Satisfaction Evaluation Form will be used to collect the data. 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 routine nursing care in the unit will be applied to the control group. Research data will be analyzed using mean, standard deviation, median, quarts, percentage, minimum and maximum values, Chi-square, and Mann Whitney-U tests.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Fertility Awareness Scale
timeFrame: 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.
measure: Fertility Preparedness Scale for Women Receiving Fertility Treatment
timeFrame: 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.
Secondary outcomes:
measure: Introductory Information Form
timeFrame: 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.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Samanpazarı
Study officials:
affiliation: Hacettepe University
name: Onur İNCE, MD
role: STUDY_DIRECTOR
References: