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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age23-45
SponsorHacettepe University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteering to participate in research

Being diagnosed with primary infertility

Starting the infertility treatment process

Having attempted IVF at most twice before

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Web-Based Mind-Body Based Awareness Program

    Other intervention

    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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Web-based mind-body awareness programActive comparator 1 intervention
Group B: Routine nursing careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fertility Awareness Scale

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, an interim test will be administered 1 day after the OPU procedure, followed by a final test one day before the pregnancy test.
2

Fertility Preparedness Scale for Women Receiving Fertility Treatment

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
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.

Secondary outcomes

1

Introductory Information Form

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hacettepe University

Lead sponsor

Assistant Professor Onur İNCE

Collaborator

Associate Professor Dr. Çiğdem YÜCEL ÖZÇIRPAN

Collaborator

This trial is not recruiting at the moment. You can still explore other options: