Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment
Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
September 5, 2024
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 22, 2026
September 15, 2025
September 1, 2025
6 months
August 28, 2024
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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''.
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.
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.
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 (1)
Introductory Information Form
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.
Study Arms (2)
Web-based mind-body awareness program
ACTIVE COMPARATORParticipants in the intervention group will participate in a web-based mind-body awareness program.
Routine nursing care
NO INTERVENTIONNo intervention will be applied to the control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hacettepe Universitylead
- Assistant Professor Onur İNCEcollaborator
- Associate Professor Dr. Çiğdem YÜCEL ÖZÇIRPANcollaborator
Study Sites (1)
Hacettepe University
Ankara, Samanpazarı, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Onur İNCE, MD
Hacettepe University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
August 28, 2024
First Posted
September 5, 2024
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
November 22, 2026
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share