Fertility AwarenessNCT06460428
Online Interactive Video Developed for Fertility Awareness
A study testing Interactive video usage in people with Fertility Awareness, run by Gazi University.
Trial summary
The main purpose of this research is to evaluate the effect of online interactive education provided to newly married couples via a web-based platform on fertility awareness.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertility Awareness
- What is being tested?
- Interactive video usage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2024to 30 Jun 2025
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being over 18 years of age
- Having applied for official marriage
- First marriage
- Must be at least a primary school graduate
Who cannot join
- Not knowing Turkish
- Having any communication problems (mental, auditory, visual, etc.)
- Having previously received preconception training/care
- There is less than 2 weeks between the marriage ceremony and the marriage application date.
- For female participants;
- Having had previous pregnancy or birth experience
Show all 12Show fewer
- Having been diagnosed with menopause
- Criteria for Exclusion from the Sample During the Study:
- Inaccessibility of the study at any stage
- Wanting to leave work
- Completion of training
- Not completing post-tests
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Online Interactive Education Provided to Couples Applying for Wedding Via Web-Based Platform on Fertility Awareness
The main purpose of this research is to evaluate the effect of online interactive education provided to newly married couples via a web-based platform on fertility awareness.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. These studies are generally given to women. But the concept of fertility in question concerns not only women but also men.The study conducted via web-based online interactive video developed to raise awareness about fertility; It is thought that raising the awareness of newly married couples, regulating fertility, and including men in this issue are important for public health and will set an example for future studies.The positive outcomes from Webb-based online videos will enable the application to be used on national and international platforms.
Read the detailed description
Fertility awareness is an understanding that enables individuals to be informed about their reproductive health, fertility cycle and reproductive systems. This understanding enables individuals to gain awareness about their reproductive capacity, fertile periods, sexual health and family planning. Increasing fertility awareness will contribute to increasing the general health and welfare of both individuals and society.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. These studies are generally aimed at women. However, the concept of fertility in question concerns not only women but also men. Individuals who are about to get married have a very important place in processing fertility awareness. The high interest in premarital sexuality, labor and birth, and the motivation for education on this subject make it important for it to be considered as a "missed opportunity" during the application period for marriage procedures. No study has been found in the literature on the development of fertility awareness, including the period of application for marriage. It is expected that the research to be conducted will contribute to the literature in terms of filling the gap in this field, obtaining new data and guiding new strategies to be created.Since information about fertility mostly involves confidential issues, individuals cannot talk about this subject comfortably and cannot obtain information. At the same time, the formation and development of fertility awareness includes individual behavioral changes. Therefore, the education given to couples can be used continuously and in the long term. For such reasons, people prefer online educational materials. Online training helps people feel more comfortable, remain anonymous while learning about these topics, and progress according to their learning pace. Web-based platforms contribute to individuals' awareness of fertility awareness and making healthy decisions by being an effective tool in reaching large audiences, being low-cost and easily accessible, and offering independence of time and place.
The research is a pretest-posttest randomized controlled experimental study conducted to evaluate the effect of online interactive education given to couples applying for marriage via a web-based platform on fertility awareness. It is planned to be conducted with 70 couples (experimental group: 35 couples, control group: 35 couples) who applied to the marriage office of Kecioren Municipality. Couples who apply to the registry office and agree to participate in the research will be asked to fill out the Introductory Information Form, Fertility Awareness Scale and Fertility Health Information Scale. Afterwards, these couples will be randomized and assigned to experimental and control groups. Training content will be created for the couples assigned to the experimental group.After receiving expert opinions on the training content, interactive videos will be prepared via the website httpp://h5ptr.org/. In these interactive videos; It is planned to have 4 modules: anatomy and physiology of the male and female reproductive system, family planning method based on fertility awareness, modern family planning method and factors affecting fertility. While watching these videos, there will be fill-in-the-blank, true-false, and multiple choice questions at certain parts of the videos. If participants answer the questions incorrectly, they will be directed to the section in the video where the answer to the question is found. A website will be prepared for couples to access these interactive videos. The address of this website and the educational content will be sent as an online file to the couples' phones or e-mails. Participants will be asked to complete these trainings within 2 weeks at most and before the wedding. After the training is completed and 1 month after the wedding, participants will fill out the Fertility Awareness Scale and Fertility Health Information Scale via an online survey (Google Forms®). No intervention will be made to the participants in the control group. Before the wedding and one month after the wedding, participants will fill out the Fertility Awareness Scale and Fertility Health Information Scale via an online survey (Google Forms®). In this way, the effect of the online interactive training we have implemented on the fertility awareness of couples applying for marriage will be evaluated. After the data collection tools are completed, the analysis and reporting part will be carried out. Statistical analyzes will be performed using Statistical Package of SocialSciences 27.0 package program. Shapiro-Wilk test, Chi-square test, dependent and independent group t test, Mann Whitney U test will be used in the analysis.
In the research conducted through web-based online interactive video developed to raise awareness about fertility; It is thought that raising the awareness of newly married couples, regulating fertility and including men in this issue are important for public health and will set an example for future studies. The positive results obtained from web-based online videos will enable the application to be used on national and international platforms.
- Conditions
- Fertility Awareness
- Being tested
- Interactive video usage
- Keywords
- Fertility awareness, Pre-wedding period, Web-based education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive video usageBehavioural
The implementation of the research was carried out in two stages. In the first stage, interactive videos were created, in the second stage, the experimental group was trained with interactive videos, and no intervention was made to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: 1. group | Experimental | Couples in the pre-wedding period will receive information about fertility awareness with the developed interactive video Receives: Behavioral: Interactive video usage |
| No Intervention: 2. Group | No intervention | Control Group (non- education): No intervention will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility Awareness Scale
Fertility Awareness Scale is a 19-item, five-point Likert type (1-Never, 2-Rarely, 3-Sometimes, 4-Often, 5-Always), two-dimensional scale: Body Awareness Sub-Dimension 7,9,10, 11,12,13,15,17,18,19 (10 items) and Cognitive Awareness Sub-Dimension 1,2,3,4,5,6,8,14,16 (9 items). There are no reverse items in the scale. The lowest score that can be obtained in the total of the Fertility Awareness Scale is 19 and the highest score is 95. As the total score from the Fertility Awareness Scale increases, the level of awareness increases. If the total score is between 19-43, awareness is classified as low, between 44-69, awareness is classified as medium, and between 70-95, awareness is classified as high level.
Measured: 3 months
Fertility Health Information Scale
Fertility Health Information Scale includes biological information regarding gender-specific reproductive health (menstrual cycle, sperm survival and quality, ability to have an erection), non-modifiable (age) and modifiable (lifestyle choices such as weight, stress, marijuana and cigarette use). /exposure) related to healthy fertility, It includes statements about factors such as stress, caffeine, diet, exercise, sleep habits, etc.). The scale consists of 30 items and has a single-factor structure. Responses to the items related to the scale are on a five-point Likert type (5-definitely yes; 4-probably yes; 3-undecided; 2-probably no; 1-definitely no). Those who choose "definitely yes" or "probably yes" are considered correct. In the evaluation, item 20 is reverse coded. Scores between 0 and 30 points can be obtained from the scale, and as the score increases, knowledge increases.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start24 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility AwarenessStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a randomized controlled experimental study with a pretest-posttest control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
- Investigators
- Şengül Yaman Sözbir, Study director, Head of Department of Obstetrics and Gynecology Nursing, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460428
- Sponsor's protocol ID
- GaziU-Hem-ŞYS-08
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Interactive Education Provided to Couples Applying for Wedding Via Web-Based Platform on Fertility Awareness
- ClinicalTrials.gov ID
- NCT06460428
- Acronym / sponsor ID
- GaziU-Hem-ŞYS-08
- Conditions
- Fertility Awareness
- Keywords
- Fertility awareness, Pre-wedding period, Web-based education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Jun 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 main purpose of this research is to evaluate the effect of online interactive education provided to newly married couples via a web-based platform on fertility awareness.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. These studies are generally given to women. But the concept of fertility in question concerns not only women but also men.The study conducted via web-based online interactive video developed to raise awareness about fertility; It is thought that raising the awareness of newly married couples, regulating fertility, and including men in this issue are important for public health and will set an example for future studies.The positive outcomes from Webb-based online videos will enable the application to be used on national and international platforms.
Detailed description
Fertility awareness is an understanding that enables individuals to be informed about their reproductive health, fertility cycle and reproductive systems. This understanding enables individuals to gain awareness about their reproductive capacity, fertile periods, sexual health and family planning. Increasing fertility awareness will contribute to increasing the general health and welfare of both individuals and society.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. These studies are generally aimed at women. However, the concept of fertility in question concerns not only women but also men. Individuals who are about to get married have a very important place in processing fertility awareness. The high interest in premarital sexuality, labor and birth, and the motivation for education on this subject make it important for it to be considered as a "missed opportunity" during the application period for marriage procedures. No study has been found in the literature on the development of fertility awareness, including the period of application for marriage. It is expected that the research to be conducted will contribute to the literature in terms of filling the gap in this field, obtaining new data and guiding new strategies to be created.Since information about fertility mostly involves confidential issues, individuals cannot talk about this subject comfortably and cannot obtain information. At the same time, the formation and development of fertility awareness includes individual behavioral changes. Therefore, the education given to couples can be used continuously and in the long term. For such reasons, people prefer online educational materials. Online training helps people feel more comfortable, remain anonymous while learning about these topics, and progress according to their learning pace. Web-based platforms contribute to individuals' awareness of fertility awareness and making healthy decisions by being an effective tool in reaching large audiences, being low-cost and easily accessible, and offering independence of time and place.
The research is a pretest-posttest randomized controlled experimental study conducted to evaluate the effect of online interactive education given to couples applying for marriage via a web-based platform on fertility awareness. It is planned to be conducted with 70 couples (experimental group: 35 couples, control group: 35 couples) who applied to the marriage office of Kecioren Municipality. Couples who apply to the registry office and agree to participate in the research will be asked to fill out the Introductory Information Form, Fertility Awareness Scale and Fertility Health Information Scale. Afterwards, these couples will be randomized and assigned to experimental and control groups. Training content will be created for the couples assigned to the experimental group.After receiving expert opinions on the training content, interactive videos will be prepared via the website httpp://h5ptr.org/. In these interactive videos; It is planned to have 4 modules: anatomy and physiology of the male and female reproductive system, family planning method based on fertility awareness, modern family planning method and factors affecting fertility. While watching these videos, there will be fill-in-the-blank, true-false, and multiple choice questions at certain parts of the videos. If participants answer the questions incorrectly, they will be directed to the section in the video where the answer to the question is found. A website will be prepared for couples to access these interactive videos. The address of this website and the educational content will be sent as an online file to the couples' phones or e-mails. Participants will be asked to complete these trainings within 2 weeks at most and before the wedding. After the training is completed and 1 month after the wedding, participants will fill out the Fertility Awareness Scale and Fertility Health Information Scale via an online survey (Google Forms®). No intervention will be made to the participants in the control group. Before the wedding and one month after the wedding, participants will fill out the Fertility Awareness Scale and Fertility Health Information Scale via an online survey (Google Forms®). In this way, the effect of the online interactive training we have implemented on the fertility awareness of couples applying for marriage will be evaluated. After the data collection tools are completed, the analysis and reporting part will be carried out. Statistical analyzes will be performed using Statistical Package of SocialSciences 27.0 package program. Shapiro-Wilk test, Chi-square test, dependent and independent group t test, Mann Whitney U test will be used in the analysis.
In the research conducted through web-based online interactive video developed to raise awareness about fertility; It is thought that raising the awareness of newly married couples, regulating fertility and including men in this issue are important for public health and will set an example for future studies. The positive results obtained from web-based online videos will enable the application to be used on national and international platforms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a randomized controlled experimental study with a pretest-posttest control group.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: 1. group | Experimental | Behavioral: Interactive video usageCouples in the pre-wedding period will receive information about fertility awareness with the developed interactive video |
| No Intervention: 2. Group | No intervention | –Control Group (non- education): No intervention will be made |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being over 18 years of age
- Having applied for official marriage
- First marriage
- Must be at least a primary school graduate
Key exclusion criteria (12 listed)
- Not knowing Turkish
- Having any communication problems (mental, auditory, visual, etc.)
- Having previously received preconception training/care
- There is less than 2 weeks between the marriage ceremony and the marriage application date.
- For female participants;
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 |
|---|---|---|
| Interactive video usageThe implementation of the research was carried out in two stages. In the first stage, interactive videos were created, in the second stage, the experimental group was trained with interactive videos, and no intervention was made to the control group. | Behavioural | Active Comparator: 1. group |
Primary outcome
Fertility Awareness Scale
Time frame: 3 months
Fertility Awareness Scale is a 19-item, five-point Likert type (1-Never, 2-Rarely, 3-Sometimes, 4-Often, 5-Always), two-dimensional scale: Body Awareness Sub-Dimension 7,9,10, 11,12,13,15,17,18,19 (10 items) and Cognitive Awareness Sub-Dimension 1,2,3,4,5,6,8,14,16 (9 items). There are no reverse items in the scale. The lowest score that can be obtained in the total of the Fertility Awareness Scale is 19 and the highest score is 95. As the total score from the Fertility Awareness Scale increases, the level of awareness increases. If the total score is between 19-43, awareness is classified as low, between 44-69, awareness is classified as medium, and between 70-95, awareness is classified as high level.
Fertility Health Information Scale
Time frame: 3 months
Fertility Health Information Scale includes biological information regarding gender-specific reproductive health (menstrual cycle, sperm survival and quality, ability to have an erection), non-modifiable (age) and modifiable (lifestyle choices such as weight, stress, marijuana and cigarette use). /exposure) related to healthy fertility, It includes statements about factors such as stress, caffeine, diet, exercise, sleep habits, etc.). The scale consists of 30 items and has a single-factor structure. Responses to the items related to the scale are on a five-point Likert type (5-definitely yes; 4-probably yes; 3-undecided; 2-probably no; 1-definitely no). Those who choose "definitely yes" or "probably yes" are considered correct. In the evaluation, item 20 is reverse coded. Scores between 0 and 30 points can be obtained from the scale, and as the score increases, knowledge increases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Fertility Awareness
Recruiting
Improving Women's Fertility Awareness and Reducing Anxiety Through Ovarian Reserve Screening and AI Counseling
Fertility Awareness, Ovarian Reserve
Not yet recruiting
Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment
Infertility, Female
Active, not recruitingObservational study
Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM Study)
Fertility, Mobile Applications
Not yet recruiting
A Modular Cloud Platform For Fertility Preservation
Fertility Preservation, Gynecologic Cancers
Recruiting
Flo Digital Contraceptive Study
Contraception Use
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.
Şengül Yaman Sözbir study director
Head of Department of Obstetrics and Gynecology Nursing, Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Interactive video usage in people with Fertility Awareness, run by Gazi University.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tenzile Hergül (+905383019593, tenzilehergul95@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: 3 months). 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?
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 14 Jun 2024.