YouthNCT06639269
Effect of Fertility Health Education Program on Fertility Health Knowledge and Healthy Life Awareness
A study testing fertility health education program in people with Youth and Education, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of the fertility health education program given to young people on fertility health knowledge and healthy life awareness. The study was planned to be conducted as a randomized controlled experimental study in the pre-test-post-test order. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- What is being tested?
- fertility health education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2024to 14 Dec 2024
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-24,
- Unmarried,
- Not having children,
- Not being pregnant or having a pregnant partner (for men)
- Not having a condition that would prevent communication (visual, hearing impairment, etc.),
- Not working on education regarding fertility health and/or healthy living awareness,
- Not having chronic children,
- Volunteers to participate in the research.
Who cannot join
- Those who could not continue the research for any reason,
- Those who did not participate in all the implemented initiatives,
- Those who did not fill out the data collection tools.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University, Naci Topçuoğlu Vocational School
Gaziantep, Şehitkamil, 27600
About this study
Official title: Effect of Fertility Health Education Program Given to Young People on Fertility Health Knowledge and Healthy Life Awareness: Randomized Controlled Study
This study was planned to examine the effect of the fertility health education program given to young people on fertility health knowledge and healthy life awareness.
The study was planned to be conducted as a randomized controlled experimental study in the pre-test-post-test order.
Read more
The population of the research will consist of students studying at Gaziantep University Naci Topçuoğlu Vocational School in the 2024-2025 academic year. The research sample was calculated as a minimum of 64 people per group (experimental and control group) and 128 people in total. Considering the possible losses that may occur during the research process, a total of 146 students are planned to be accepted.
Data in the research; It will be collected through "Introductory Information Form", "Fertility Health Information Scale", "Healthy Life Awareness Scale" and "Training Program Satisfaction Survey".
In the research, the Fertility Health Education Program consisting of 3 sessions will be applied to the intervention group, and the control group will be informed about the research process and the data collection forms to be used. Data collection forms will be applied to students in both groups before and after the training.
In the analysis of the data; mean±standard deviation and median (minimum-maximum) will be used for quantitative variables as descriptors, and the number of patients (percentage) will be used for qualitative variables.
Student-t test, Mann-Whitney U test, One Way ANOVA test, Kruskal Wallis H test, Chi-square and Fisher exact tests will be used in the analysis, depending on the assumption of normal distribution. Risk factors affecting the qualitative dependent variable will be examined with Logistic Regression analysis. The statistical significance level will be taken as 0.05.
Read the detailed description
The study is planned to be conducted in three stages: first stage (pre-intervention), second stage (intervention) and third stage (post-intervention). First Stage (Pre-Intervention): Students studying at the Vocational School where the study will be conducted will be informed about the study and invited to participate in the study. A list of students who meet the inclusion criteria and agree to participate in the study will be created. The gender and phone numbers of the students will be recorded while creating the list. The list will be sent to a statistician to determine the intervention and control groups using the randomization method. Students will be randomized into the intervention and control groups with similar gender distribution. Consent will be obtained from the participants included in the study through the Informed Consent Form.
Second Stage (Intervention): The "Fertility Health Education Program", which will be developed in line with literature information, will be applied to the intervention group. Both the pre-test and the first session of the training will be held on the same day. All participants will be asked to fill out the Introductory Information Form, Fertility Health Information Scale and Healthy Life Awareness Scale during the pre-test stage.
Third Phase (Post-Intervention): In this study, the post-test is planned to be administered 4 weeks after the last training. In order to complete the post-test, students in the intervention group will be contacted 4 weeks after the last training and the control group will be contacted 6 weeks after the pre-test and the Fertility Health Knowledge Scale and Healthy Life Awareness Scale will be completed.
In order to conduct the research, permission was obtained from Ankara University Ethics Committee with the decision numbered 06/04 and dated 03.04.2024, and in order to collect the research data, permission was obtained from Gaziantep University Naci Topçuoğlu Vocational School, where the research will be conducted, dated 02.09.2024 and numbered E-87841438-100-539736. Data collection forms will be distributed to the volunteers by the researcher, and the forms will be filled in by the volunteers. While filling out the forms, a distanced seating arrangement will be created so that the volunteers cannot see each other's answers. The data obtained from the research will be analyzed anonymously and the confidentiality of the data will be ensured. The research will be conducted in accordance with the Declaration of Helsinki. The researcher will inform the students who make up the sample that participation in the research is voluntary and that they can withdraw from the research at any time, and the purpose and method of the research will be explained. In addition to their verbal consent, students who agree to participate in the research will be asked to sign an Informed Consent Form. After the completion of the research, students in the control group who want to receive training and students who volunteer to participate in the study but cannot be in the intervention or control groups and want to receive training will be given a single session of fertility health training, an education booklet will be distributed, and a brochure will be sent to their phones.
- Being tested
- fertility health education program
- Keywords
- youth, education, Fertility Health Information, Healthy Life Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fertility health education programOther
Also called fertility health education, education program
The intervention group will be implemented with a "fertility health education program" for which a literature information document will be created. In the training; booklets and brochures will be prepared. The control unit will include information on programming and data collection forms to be used. Those selected from the intervention group will be divided into groups of 10-15 people. The training program will consist of 3 sessions. Training sessions will be planned on days and hours that are convenient for the researcher, classrooms and students. For students who cannot attend group training, make-up training will be provided within a week. In this study, the time between sessions will be planned as 1 week. The sessions in this study will be planned to be in groups of 10-15 people and will last 50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | All those who remain will be asked to fill out the Introductory Information Form, Fertility Health Information Scale and Healthy Life Awareness Scale during the pre-test phase. 6 weeks after the pre-test, the authorized person in the control groups will be contacted and expected to complete the Fertility Health Information Scale and Healthy Life Awareness Scale. The control group will not receive training. |
| educational program intervention group | Experimental | The "Fertility Health Education Program", which will be created in line with literature information, will be applied to the intervention group. Participants selected for the intervention group will be divided into groups of 10-15 people. Participants in each group will be informed about the date, time and location of the education program through methods suitable for the student; e-mail, phone or message. The education program will consist of 3 sessions. Education sessions will be planned on days and times when the researcher, classrooms and students are available. For students who cannot attend group education, make-up education will be provided within a week. In this study, the interval between sessions will be planned as 1 week. Group education will be planned according to the times when the students are available. PowerPoint presentation, models, booklets and brochures will be used in the education sessions. Receives: Other: fertility health education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility Health Information Level
Fertility Health Information Scale. The scale consists of 30 items and has a single factor structure. Responses to the items related to the scale are in the five-point Likert type (5-definitely yes; 4-probably yes; 3-undecided; 2-probably no; 1-definitely no). The 20th item is reverse coded in the evaluation. Then, the responses are classified as "correct" or "incorrect". Those who mark the option "definitely yes" and "probably yes" are accepted as correct. The knowledge level is expressed as a percentage based on the scale items and their total.
Measured: 6 months
Healthy Life Awareness
Healthy Life Awareness Scale is a 5-point Likert-type scale consisting of 4 sub-dimensions and 15 items. It consists of the sub-dimensions of change (items 1-5), socialization (items 6-9), responsibility (items 10-12), and nutrition (items 13-15). The lowest score to be obtained from the scale is 15, the highest score is 75. A high score from the scale is evaluated as a high level of healthy life awareness.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Oct 2024
- Primary completion13 Dec 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YouthStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Single group
- Model description
- In our study, we will have two groups: control and intervention. A 3-session fertility health education program will be applied to the students in the intervention group.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ERKAN KIRMIZIGÜL, Ankara University
- Investigators
- Funda Ozdemir, Assoc. Prof., Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639269
- Sponsor's protocol ID
- AU-IHS-REK-01
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fertility Health Education Program Given to Young People on Fertility Health Knowledge and Healthy Life Awareness: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06639269
- Acronym / sponsor ID
- AU-IHS-REK-01
- Keywords
- youth, education, Fertility Health Information, Healthy Life Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 15 Oct 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.
This study was planned to examine the effect of the fertility health education program given to young people on fertility health knowledge and healthy life awareness.
The study was planned to be conducted as a randomized controlled experimental study in the pre-test-post-test order.
The population of the research will consist of students studying at Gaziantep University Naci Topçuoğlu Vocational School in the 2024-2025 academic year. The research sample was calculated as a minimum of 64 people per group (experimental and control group) and 128 people in total. Considering the possible losses that may occur during the research process, a total of 146 students are planned to be accepted.
Data in the research; It will be collected through "Introductory Information Form", "Fertility Health Information Scale", "Healthy Life Awareness Scale" and "Training Program Satisfaction Survey".
In the research, the Fertility Health Education Program consisting of 3 sessions will be applied to the intervention group, and the control group will be informed about the research process and the data collection forms to be used. Data collection forms will be applied to students in both groups before and after the training.
In the analysis of the data; mean±standard deviation and median (minimum-maximum) will be used for quantitative variables as descriptors, and the number of patients (percentage) will be used for qualitative variables.
Student-t test, Mann-Whitney U test, One Way ANOVA test, Kruskal Wallis H test, Chi-square and Fisher exact tests will be used in the analysis, depending on the assumption of normal distribution. Risk factors affecting the qualitative dependent variable will be examined with Logistic Regression analysis. The statistical significance level will be taken as 0.05.
Detailed description
The study is planned to be conducted in three stages: first stage (pre-intervention), second stage (intervention) and third stage (post-intervention). First Stage (Pre-Intervention): Students studying at the Vocational School where the study will be conducted will be informed about the study and invited to participate in the study. A list of students who meet the inclusion criteria and agree to participate in the study will be created. The gender and phone numbers of the students will be recorded while creating the list. The list will be sent to a statistician to determine the intervention and control groups using the randomization method. Students will be randomized into the intervention and control groups with similar gender distribution. Consent will be obtained from the participants included in the study through the Informed Consent Form.
Second Stage (Intervention): The "Fertility Health Education Program", which will be developed in line with literature information, will be applied to the intervention group. Both the pre-test and the first session of the training will be held on the same day. All participants will be asked to fill out the Introductory Information Form, Fertility Health Information Scale and Healthy Life Awareness Scale during the pre-test stage.
Third Phase (Post-Intervention): In this study, the post-test is planned to be administered 4 weeks after the last training. In order to complete the post-test, students in the intervention group will be contacted 4 weeks after the last training and the control group will be contacted 6 weeks after the pre-test and the Fertility Health Knowledge Scale and Healthy Life Awareness Scale will be completed.
In order to conduct the research, permission was obtained from Ankara University Ethics Committee with the decision numbered 06/04 and dated 03.04.2024, and in order to collect the research data, permission was obtained from Gaziantep University Naci Topçuoğlu Vocational School, where the research will be conducted, dated 02.09.2024 and numbered E-87841438-100-539736. Data collection forms will be distributed to the volunteers by the researcher, and the forms will be filled in by the volunteers. While filling out the forms, a distanced seating arrangement will be created so that the volunteers cannot see each other's answers. The data obtained from the research will be analyzed anonymously and the confidentiality of the data will be ensured. The research will be conducted in accordance with the Declaration of Helsinki. The researcher will inform the students who make up the sample that participation in the research is voluntary and that they can withdraw from the research at any time, and the purpose and method of the research will be explained. In addition to their verbal consent, students who agree to participate in the research will be asked to sign an Informed Consent Form. After the completion of the research, students in the control group who want to receive training and students who volunteer to participate in the study but cannot be in the intervention or control groups and want to receive training will be given a single session of fertility health training, an education booklet will be distributed, and a brochure will be sent to their phones.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In our study, we will have two groups: control and intervention. A 3-session fertility health education program will be applied to the students in the intervention group.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –All those who remain will be asked to fill out the Introductory Information Form, Fertility Health Information Scale and Healthy Life Awareness Scale during the pre-test phase. 6 weeks after the pre-test, the authorized person in the control groups will be contacted and expected to complete the Fertility Health Information Scale and Healthy Life Awareness Scale. The control group will not receive training. |
| educational program intervention group | Experimental | Other: fertility health education programThe "Fertility Health Education Program", which will be created in line with literature information, will be applied to the intervention group. Participants selected for the intervention group will be divided into groups of 10-15 people. Participants in each group will be informed about the date, time and location of the education program through methods suitable for the student; e-mail, phone or message. The education program will consist of 3 sessions. Education sessions will be planned on days and times when the researcher, classrooms and students are available. For students who cannot attend group education, make-up education will be provided within a week. In this study, the interval between sessions will be planned as 1 week. Group education will be planned according to the times when the students are available. PowerPoint presentation, models, booklets and brochures will be used in the education sessions. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between the ages of 18-24,
- Unmarried,
- Not having children,
- Not being pregnant or having a pregnant partner (for men)
- Not having a condition that would prevent communication (visual, hearing impairment, etc.),
Key exclusion criteria (3 listed)
- Those who could not continue the research for any reason,
- Those who did not participate in all the implemented initiatives,
- Those who did not fill out the data collection tools.
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 |
|---|---|---|
| fertility health education programAlso: fertility health education, education programThe intervention group will be implemented with a "fertility health education program" for which a literature information document will be created. In the training; booklets and brochures will be prepared. The control unit will include information on programming and data collection forms to be used. Those selected from the intervention group will be divided into groups of 10-15 people. The training program will consist of 3 sessions. Training sessions will be planned on days and hours that are convenient for the researcher, classrooms and students. For students who cannot attend group training, make-up training will be provided within a week. In this study, the time between sessions will be planned as 1 week. The sessions in this study will be planned to be in groups of 10-15 people and will last 50 minutes. | Other | educational program intervention group |
Primary outcome
Fertility Health Information Level
Time frame: 6 months
Fertility Health Information Scale. The scale consists of 30 items and has a single factor structure. Responses to the items related to the scale are in the five-point Likert type (5-definitely yes; 4-probably yes; 3-undecided; 2-probably no; 1-definitely no). The 20th item is reverse coded in the evaluation. Then, the responses are classified as "correct" or "incorrect". Those who mark the option "definitely yes" and "probably yes" are accepted as correct. The knowledge level is expressed as a percentage based on the scale items and their total.
Healthy Life Awareness
Time frame: 6 months
Healthy Life Awareness Scale is a 5-point Likert-type scale consisting of 4 sub-dimensions and 15 items. It consists of the sub-dimensions of change (items 1-5), socialization (items 6-9), responsibility (items 10-12), and nutrition (items 13-15). The lowest score to be obtained from the scale is 15, the highest score is 75. A high score from the scale is evaluated as a high level of healthy life awareness.
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Funda Ozdemir, Assoc. Prof. study director
Ankara 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 fertility health education program in people with Youth and Education, run by Ankara 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 3 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 21 Feb 2025. 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?
Fertility Health Information Level (time frame: 6 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 21 Feb 2025.