Infertility, FemaleNCT06585137
Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment
A study testing Web-Based Mind-Body Based Awareness Program in people with Infertility, Female, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Web-Based Mind-Body Based Awareness Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2026to 22 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazarı, 06100
Gülşah VURAL AKTAN, Master of Science in Nursing, +905422860942, gvuralaktan@gmail.com
Çiğdem YÜCEL ÖZÇIRPAN, PhD, +903123051580, cigdemyuc@gmail.com
About this study
Official title: The Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
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.
Read the detailed description
Improving fertility awareness in women undergoing infertility treatment may facilitate changes in lifestyle behaviors that can enhance fertility. Increasing fertility awareness among infertile individuals may improve the likelihood of pregnancy and the chance of achieving a healthy pregnancy. It may also positively influence general health and reproductive health and support the modification of negative lifestyle behaviors that could affect the infertility treatment process. Fertility awareness may contribute to fertility readiness, which in turn may have a positive impact on treatment outcomes.
This study 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 fertility readiness levels in women undergoing infertility treatment. The study will be carried out with women receiving infertility treatment at the In Vitro Fertilization Unit of Hacettepe University Faculty of Medicine.
The sample will consist of women who voluntarily agree to participate in the study, have initiated the infertility treatment process, have undergone a maximum of two IVF attempts, are able to speak and understand Turkish, have at least a primary school education, are not participating in any psychological or social support group, and have not completed or are not currently participating in any mind-body program related to fertility.
The sample size was determined in consultation with a statistician. Based on a review of the literature, particularly a study examining the effects of progressive muscle relaxation exercises on mental health and treatment outcomes in women undergoing IVF, a power analysis was conducted to determine the required sample size. The power analysis indicated that, for a power of 90%, a 95% confidence level, an effect size of f = 0.198, two groups (intervention and control), and three repeated measurements, a total sample size of 48 participants was required.
Considering the anticipated attrition resulting from the transition from chemical pregnancy to clinical pregnancy and the potential losses inherent in the IVF treatment process, the calculated sample size was inflated by 60%. Accordingly, the study sample was planned as 78 participants in total, with 39 in the intervention group and 39 in the control group. After randomization, no new participants will be added to replace those who withdraw or are excluded from the study for any reason.
The data collection instruments will include a Demographic Information Form, the Fertility Awareness Scale, and the Fertility Readiness Scale.
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 control group will receive routine nursing care provided in the unit.
The research data will be analyzed using mean, standard deviation, median, quartiles, percentages, minimum and maximum values, as well as Chi-square and Mann-Whitney U tests.
- Conditions
- Infertility, Female
- Being tested
- Web-Based Mind-Body Based Awareness Program
- Keywords
- Nursing, Infertility, Nursing Theory, Fertility, Awareness, Meleis, Fertility readiness
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Mind-Body Based Awareness ProgramOther
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 group | Role | What they receive |
|---|---|---|
| Web-based mind-body awareness program | Active comparator | Participants in the intervention group will participate in a web-based mind-body awareness program. Receives: Other: Web-Based Mind-Body Based Awareness Program |
| Routine nursing care | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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''.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start10 Oct 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Assistant Professor Onur İNCE, Associate Professor Dr. Çiğdem YÜCEL ÖZÇIRPAN
- Responsible party
- Principal investigator, Gülşah VURAL AKTAN, Hacettepe University
- Investigators
- Onur İNCE, MD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585137
- Sponsor's protocol ID
- PhD-01
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://doi.org/10.1002/nur.22187
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Web-Based Mind-Body Awareness Program Based on Meleis Transition Theory on Women Receiving Infertility Treatment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06585137
- Acronym / sponsor ID
- PhD-01
- Conditions
- Infertility, Female
- Keywords
- Nursing, Infertility, Nursing Theory, Fertility, Awareness, Meleis, Fertility readiness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Assistant Professor Onur İNCE, Associate Professor Dr. Çiğdem YÜCEL ÖZÇIRPAN
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Improving fertility awareness in women undergoing infertility treatment may facilitate changes in lifestyle behaviors that can enhance fertility. Increasing fertility awareness among infertile individuals may improve the likelihood of pregnancy and the chance of achieving a healthy pregnancy. It may also positively influence general health and reproductive health and support the modification of negative lifestyle behaviors that could affect the infertility treatment process. Fertility awareness may contribute to fertility readiness, which in turn may have a positive impact on treatment outcomes.
This study 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 fertility readiness levels in women undergoing infertility treatment. The study will be carried out with women receiving infertility treatment at the In Vitro Fertilization Unit of Hacettepe University Faculty of Medicine.
The sample will consist of women who voluntarily agree to participate in the study, have initiated the infertility treatment process, have undergone a maximum of two IVF attempts, are able to speak and understand Turkish, have at least a primary school education, are not participating in any psychological or social support group, and have not completed or are not currently participating in any mind-body program related to fertility.
The sample size was determined in consultation with a statistician. Based on a review of the literature, particularly a study examining the effects of progressive muscle relaxation exercises on mental health and treatment outcomes in women undergoing IVF, a power analysis was conducted to determine the required sample size. The power analysis indicated that, for a power of 90%, a 95% confidence level, an effect size of f = 0.198, two groups (intervention and control), and three repeated measurements, a total sample size of 48 participants was required.
Considering the anticipated attrition resulting from the transition from chemical pregnancy to clinical pregnancy and the potential losses inherent in the IVF treatment process, the calculated sample size was inflated by 60%. Accordingly, the study sample was planned as 78 participants in total, with 39 in the intervention group and 39 in the control group. After randomization, no new participants will be added to replace those who withdraw or are excluded from the study for any reason.
The data collection instruments will include a Demographic Information Form, the Fertility Awareness Scale, and the Fertility Readiness Scale.
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 control group will receive routine nursing care provided in the unit.
The research data will be analyzed using mean, standard deviation, median, quartiles, percentages, minimum and maximum values, as well as Chi-square and Mann-Whitney U tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based mind-body awareness program | Active comparator | Other: Web-Based Mind-Body Based Awareness ProgramParticipants in the intervention group will participate in a web-based mind-body awareness program. |
| Routine nursing care | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Mind-Body Based Awareness ProgramThe 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. | Other | Web-based mind-body awareness program |
Primary outcome
Fertility Awareness Scale
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.
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
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.
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.
1 secondary outcome
Introductory Information 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publicationhttps://doi.org/10.1002/nur.22187
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Onur İNCE, MD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Mind-Body Based Awareness Program in people with Infertility, Female, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülşah VURAL AKTAN, Master of Science of Nursing (+905422860942, gvuralaktan2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility Awareness Scale (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.