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

NCT ID: NCT06585137

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-11-22

Brief Summary

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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

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Web-based mind-body awareness program

Participants in the intervention group will participate in a web-based mind-body awareness program.

Group Type ACTIVE_COMPARATOR

Web-Based Mind-Body Awareness Program

Intervention Type OTHER

The program has been developed in line with peer-reviewed literature and expert opinions. It will incorporate a nursing approach based on the Meleis transition theory, education, mind-body awareness practices, and messages specific to women's health. Participants will be involved in an awareness program consisting of 3 sessions over an average of 2 weeks. Participants will be asked to complete their first final test one day after the egg retrieval (OPU) procedure, i.e., an average of 8-12 days after ovulation induction. There will be no intervention between the embryo transfer and the pregnancy test day. During this time period, interactive sessions between the researcher and participants will be conducted, and nursing care will be provided according to Meleis. The implementation phase of the study will be completed with 39 participants after the second final test following the pregnancy test.

Routine nursing care

No intervention will be applied to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-Based Mind-Body Awareness Program

The program has been developed in line with peer-reviewed literature and expert opinions. It will incorporate a nursing approach based on the Meleis transition theory, education, mind-body awareness practices, and messages specific to women's health. Participants will be involved in an awareness program consisting of 3 sessions over an average of 2 weeks. Participants will be asked to complete their first final test one day after the egg retrieval (OPU) procedure, i.e., an average of 8-12 days after ovulation induction. There will be no intervention between the embryo transfer and the pregnancy test day. During this time period, interactive sessions between the researcher and participants will be conducted, and nursing care will be provided according to Meleis. The implementation phase of the study will be completed with 39 participants after the second final test following the pregnancy test.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

23 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistant Professor Onur İNCE

UNKNOWN

Sponsor Role collaborator

Associate Professor Dr. Çiğdem YÜCEL ÖZÇIRPAN

UNKNOWN

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Gülşah VURAL AKTAN

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Onur İNCE, MD

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University

Ankara, Samanpazarı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gülşah VURAL AKTAN, Master of Science of Nursing

Role: CONTACT

+905422860942

Çiğdem YÜCEL ÖZÇIRPAN, PhD

Role: CONTACT

+903123051580

Facility Contacts

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Gülşah VURAL AKTAN, Master of Science in Nursing

Role: primary

+905422860942

Çiğdem YÜCEL ÖZÇIRPAN, PhD

Role: backup

+903123051580

Other Identifiers

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PhD-01

Identifier Type: -

Identifier Source: org_study_id

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