Infertility, FemaleeducationNCT05413629
The Effect of Web Based Education on the Level of Coping With Infertility Stress and Infertility Self-Efficacy
A study testing Web-based patient education for the intrauterine insemination (IUI) treatment process in people with Infertility, Female and Educational Problems, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and… Read more about this study
- Who is it for?
- Ages 23 to 39 years, women only
- Conditions the study is for
- Infertility, Female, Educational Problems, Intrauterine Insemination
- What is being tested?
- Web-based patient education for the intrauterine insemination (IUI) treatment process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Applying to Düzce University Health Practice and Research Center Infertility Polyclinic
- Primary infertility,
- Controlled Ovarian Hyperstimulation (COH) planned for the treatment of intrauterine insemination (IUI),
- Having the equipment (mobile phone, computer, tablet, internet) to access web-based education,
- No chronic disease,
- No diagnosed psychiatric disease,
- Agreeing to participate in the research,
- Having the ability to understand and comprehend the questionnaires
Who cannot join
- Controlled Ovarian Hyperstimulation (COH) is not planned in the treatment of intrauterine insemination (IUI),
- Give up treatment,
- Not having the equipment (mobile phone, computer, tablet, internet) to access web-based education,
- Having a chronic disease,
- Having a diagnosed psychiatric disease,
- Those who do not agree to participate in the research,
- Those who do not have the ability to understand and comprehend the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Web Based Education on the Treatment Process of Women Undergoing Intrauterine Insemination (IUI) on the Level of Coping With Infertility Stress and Infertility Self-Efficacy
In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and quality of education by integrating web-based education into the nursing care process, and continuous traceability, to prevention of possible wrong treatment process management in the field of infertility, to prevention of possible loss of cycles and to prevention the material and moral couple from being adversely affected by this process.
Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women between the ages of 23-39 who applied to Düzce University Health Practice and Research Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design consisting of two experimental and two control groups will be used. The study planned to consist of a total of 132 patients, 33 patients in each group, taking into account possible data losses. By design, all of the pre-test and post-test measurement tools will be applied to the first experimental and control group, and only the post-test measurement tools will be applied to the second experimental and control group. Randomization will be applied in determining the experimental and control groups. The data will be collected using Personal Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). Research data will be collected in approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment.
Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI.
Read the detailed description
Infertility is defined as the inability to conceive or to continue the pregnancy, despite having unprotected sexual intercourse at least twice a week for a year and at least twice a week. It is reported that more than 80 million people around the world are unable to have children due to medical reasons, and 15% of couples in Turkey are diagnosed with infertility. When we look at the literature, it is suggested that infertility and assisted reproduction treatments cause an increase in the level of stress, depression and anxiety in individuals and that it is necessary to strengthen their coping with this process.
Aim: This study was planned as a randomized controlled experimental study in order to examine the effect of web-based education about the treatment process on the level of coping with infertility stress and infertility self-efficacy to women undergoing Intrauterine Insemination (IUI) treatment.
Objective: In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and quality of education by integrating web-based education into the nursing care process, and continuous traceability, to prevention of possible wrong treatment process management in the field of infertility, to prevention of possible loss of cycles and to prevention the material and moral couple from being adversely affected by this process.
Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women between the ages of 23-39 who applied to Düzce University Health Practice and Research Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design consisting of two experimental and two control groups will be used. Power analysis (G*Power 3.1.9.2) was performed on the basis of a previous similar research in the selection of the sample. Accordingly, the sample of the study was planned to consist of a total of 132 patients, 33 patients in each group, taking into account possible data losses. By design, all of the pre-test and post-test measurement tools will be applied to the first experimental and control group, and only the post-test measurement tools will be applied to the second experimental and control group. Randomization will be applied in determining the experimental and control groups. The data will be collected using Personal Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). The preliminary application of the research will be completed with an average of 16 women, who constitute at least 10% of the sample of 132 people. Research data will be collected in approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment.
In the research, the experimental group will be given a brief face-to-face briefing about the treatment process as well as a detailed training via the website. Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI. The patients in the control group, on the other hand, will be given the hospital's drug administration brochure after brief face-to-face information and no other intervention will be made. When the patients come back to the hospital for IUI treatment, they will fill out the Infertility Stress Scale (ISS), Coping with the Infertility Stress Scale (CISS), Infertility Self-Efficacy Scale - Short Form (ISE-SF). BHCG results of the patients will be learned on the 14th day after IUI.
- Being tested
- Web-based patient education for the intrauterine insemination (IUI) treatment process
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based patient education for the intrauterine insemination (IUI) treatment processOther
Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI.
| Study group | Role | What they receive |
|---|---|---|
| Group1 (n=33) | No intervention | Control 1: Pretest negative and post test positive group |
| Group 2 (n=33) | No intervention | Control 2: Pretest positive and post test positive |
| Group 3 (n=33) | Experimental | Experimental 1: Pretest negative and post test positive Receives: Other: Web-based patient education for the intrauterine insemination (IUI) treatment process |
| Group 4 ( n=33) | Experimental | Experimental 2: Pretest positive and post test positive Receives: Other: Web-based patient education for the intrauterine insemination (IUI) treatment process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infertility Stress Scale
The level of infertility stress assessed by Infertility Stress Scale (ISS). The scale consists of 3 sub-dimensions. The total minimum score that can be obtained from the scale is 0 and the total maximum score is 46. As the score obtained from the scale increases, the stress level of the individual increases and as the score decreases, the stress level decreases.
Measured: 24 to 27 days
Coping with the Infertility Stress Scale
The level of coping with infertility stress assessed by Coping with the Infertility Stress Scale (CISS). The scale consists of 4 sub-dimensions. The total minimum score that can be obtained from the scale is 19 and the total maximum score is 74. As the score obtained from the scale increases, the individual copes better with stress, and as it decreases, the individual copes less well.
Measured: 24 to 27 days
Secondary outcomes (1)
Infertility Self-Efficacy Scale - Short Form
The level of infertility self-efficacy assessed by ISE-SF (Infertility Self-Efficacy Scale - Short Form). The minimum score that can be obtained from the scale is 8 and the maximum score is 32. Higher scores indicate higher self-efficacy and lower scores indicate lower self-efficacy.
Measured: 24 to 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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.
- 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
- Model description
- Solomon four-group, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nurdan Demirci, Prof., Study director, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413629
- Sponsor's protocol ID
- Duzce U
- Other IDs
- hilalkaradeniz1
- Acronym
- education
- Status last verified
- Feb 2024
- First submitted
- 9 May 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yalazi RO, Demirci N. The effect of bladder training with mobile application on quality of life and sexual satisfaction in women with overactive bladder: randomized controlled study. World J Urol. 2025 Sep 25;43(1):573. doi: 10.1007/s00345-025-05917-6.
PubMed 40996496
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web Based Education on the Treatment Process of Women Undergoing Intrauterine Insemination (IUI) on the Level of Coping With Infertility Stress and Infertility Self-Efficacy
- ClinicalTrials.gov ID
- NCT05413629
- Acronym / sponsor ID
- education / Duzce U
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 10 Jun 2022 (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.
In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and quality of education by integrating web-based education into the nursing care process, and continuous traceability, to prevention of possible wrong treatment process management in the field of infertility, to prevention of possible loss of cycles and to prevention the material and moral couple from being adversely affected by this process.
Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women between the ages of 23-39 who applied to Düzce University Health Practice and Research Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design consisting of two experimental and two control groups will be used. The study planned to consist of a total of 132 patients, 33 patients in each group, taking into account possible data losses. By design, all of the pre-test and post-test measurement tools will be applied to the first experimental and control group, and only the post-test measurement tools will be applied to the second experimental and control group. Randomization will be applied in determining the experimental and control groups. The data will be collected using Personal Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). Research data will be collected in approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment.
Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI.
Detailed description
Infertility is defined as the inability to conceive or to continue the pregnancy, despite having unprotected sexual intercourse at least twice a week for a year and at least twice a week. It is reported that more than 80 million people around the world are unable to have children due to medical reasons, and 15% of couples in Turkey are diagnosed with infertility. When we look at the literature, it is suggested that infertility and assisted reproduction treatments cause an increase in the level of stress, depression and anxiety in individuals and that it is necessary to strengthen their coping with this process.
Aim: This study was planned as a randomized controlled experimental study in order to examine the effect of web-based education about the treatment process on the level of coping with infertility stress and infertility self-efficacy to women undergoing Intrauterine Insemination (IUI) treatment.
Objective: In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and quality of education by integrating web-based education into the nursing care process, and continuous traceability, to prevention of possible wrong treatment process management in the field of infertility, to prevention of possible loss of cycles and to prevention the material and moral couple from being adversely affected by this process.
Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women between the ages of 23-39 who applied to Düzce University Health Practice and Research Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design consisting of two experimental and two control groups will be used. Power analysis (G*Power 3.1.9.2) was performed on the basis of a previous similar research in the selection of the sample. Accordingly, the sample of the study was planned to consist of a total of 132 patients, 33 patients in each group, taking into account possible data losses. By design, all of the pre-test and post-test measurement tools will be applied to the first experimental and control group, and only the post-test measurement tools will be applied to the second experimental and control group. Randomization will be applied in determining the experimental and control groups. The data will be collected using Personal Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). The preliminary application of the research will be completed with an average of 16 women, who constitute at least 10% of the sample of 132 people. Research data will be collected in approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment.
In the research, the experimental group will be given a brief face-to-face briefing about the treatment process as well as a detailed training via the website. Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI. The patients in the control group, on the other hand, will be given the hospital's drug administration brochure after brief face-to-face information and no other intervention will be made. When the patients come back to the hospital for IUI treatment, they will fill out the Infertility Stress Scale (ISS), Coping with the Infertility Stress Scale (CISS), Infertility Self-Efficacy Scale - Short Form (ISE-SF). BHCG results of the patients will be learned on the 14th day after IUI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Solomon four-group, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group1 (n=33) | No intervention | –Control 1: Pretest negative and post test positive group |
| Group 2 (n=33) | No intervention | –Control 2: Pretest positive and post test positive |
| Group 3 (n=33) | Experimental | Other: Web-based patient education for the intrauterine insemination (IUI) treatment processExperimental 1: Pretest negative and post test positive |
| Group 4 ( n=33) | Experimental | Other: Web-based patient education for the intrauterine insemination (IUI) treatment processExperimental 2: Pretest positive and post test positive |
Who may qualify
- Ages
- 23 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Applying to Düzce University Health Practice and Research Center Infertility Polyclinic
- Primary infertility,
- Controlled Ovarian Hyperstimulation (COH) planned for the treatment of intrauterine insemination (IUI),
- Having the equipment (mobile phone, computer, tablet, internet) to access web-based education,
- No chronic disease,
Key exclusion criteria (7 listed)
- Controlled Ovarian Hyperstimulation (COH) is not planned in the treatment of intrauterine insemination (IUI),
- Give up treatment,
- Not having the equipment (mobile phone, computer, tablet, internet) to access web-based education,
- Having a chronic disease,
- Having a diagnosed psychiatric disease,
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 patient education for the intrauterine insemination (IUI) treatment processWeb-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI. | Other | Group 3 (n=33), Group 4 ( n=33) |
Primary outcome
Infertility Stress Scale
Time frame: 24 to 27 days
The level of infertility stress assessed by Infertility Stress Scale (ISS). The scale consists of 3 sub-dimensions. The total minimum score that can be obtained from the scale is 0 and the total maximum score is 46. As the score obtained from the scale increases, the stress level of the individual increases and as the score decreases, the stress level decreases.
Coping with the Infertility Stress Scale
Time frame: 24 to 27 days
The level of coping with infertility stress assessed by Coping with the Infertility Stress Scale (CISS). The scale consists of 4 sub-dimensions. The total minimum score that can be obtained from the scale is 19 and the total maximum score is 74. As the score obtained from the scale increases, the individual copes better with stress, and as it decreases, the individual copes less well.
1 secondary outcome
Infertility Self-Efficacy Scale - Short Form
Time frame: 24 to 27 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40996496Yalazi RO, Demirci N. The effect of bladder training with mobile application on quality of life and sexual satisfaction in women with overactive bladder: randomized controlled study. World J Urol. 2025 Sep 25;43(1):573. doi: 10.1007/s00345-025-05917-6.
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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. This study is not recruiting at the moment.
Nurdan Demirci, Prof. study director
Duzce 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 patient education for the intrauterine insemination (IUI) treatment process in people with Infertility, Female and Educational Problems, run by Duzce 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 7 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: finished, as of the sponsor's last update on 23 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infertility Stress Scale (time frame: 24 to 27 days). 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 NCT05413629, 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 23 Feb 2024.