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Starting soon Not applicable

Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment

NCT06585137 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-10-10
Last updated
2026-09-11

Condition(s) studied

Infertility, Female

Investigational drug(s) / intervention(s)

Web-Based Mind-Body Based Awareness Program

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 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.

Study 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.

Eligibility

Sex
FEMALE
Min age
23 Years
Max age
45 Years
Healthy volunteers
No
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 outcome measure(s)

  • Fertility Awareness Scale — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Hacettepe University Ankara Samanpazarı
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06585137 on ClinicalTrials.gov ↗ ← All trials in Turkey