Video-Based Fertility Awareness TrainingNCT06541717
Video Intervention Fertility Awareness Training
A study testing Video-Based Fertility Awareness Training in people with Video-Based Fertility Awareness Training, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effects of video-based ovarian reserve awareness training applied to midwifery students on ovarian reserve, fertility awareness and anxiety of midwifery students. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Video-Based Fertility Awareness Training
- What is being tested?
- Video-Based Fertility Awareness Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2024to 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be a volunteer to participate in the research.
- To be an active student in the 2nd year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
Who cannot join
- Being a passive student in the 2nd year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midwifery Students' Ovarian Reserve and Fertility Awareness: Effectiveness of Video Intervention
This study was planned to evaluate the effects of video-based ovarian reserve awareness training applied to midwifery students on ovarian reserve, fertility awareness and anxiety of midwifery students. The research population will consist of second-year students studying in the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBU) in the fall semester of 2024-2025 academic year (N: 80). In this study planned as a semi-experimental pre-test and post-test design with a control group, in order to determine the sample size; the data were normally distributed, the standard deviation of the main mass was estimated as 1 and the effect size (effect size, difference) was estimated as 0.8. For the analysis to be conducted, it was calculated that the highest power value of the study would be 0.942182 if two independent n₁=40, n₂=40 samples were taken at a significance level of 5%. The G-power analysis result is given below.
Students who volunteer to participate in the study will be assigned to the intervention and control groups with the computer-aided simple random sampling method. Computer-aided randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www.randomizer.org and random assignment will be made to the intervention and control groups. The study will be conducted single-blind. Midwifery students in the intervention group of the study will be given video-based ovarian reserve and fertility awareness training. A pre-training information meeting will be held with midwifery students who volunteered to participate in the study and were assigned to the intervention group. The midwifery students will be administered the "Ovarian Reserve Information Form", "Fertility Awareness Scale" and "State Anxiety Scale" before and after the training.
- Conditions
- Video-Based Fertility Awareness Training
- Being tested
- Video-Based Fertility Awareness Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Fertility Awareness TrainingOther
Students will be shown 3 15-minute videos created by researchers on the anatomy and physiology of the male and female reproductive systems, the physiology of pregnancy, fertility awareness development and its importance in terms of infertility.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group (n:40) | Experimental | Students will be shown 3 15-minute videos created by researchers on the anatomy and physiology of the male and female reproductive systems, the physiology of pregnancy, fertility awareness development and its importance in terms of infertility. Receives: Other: Video-Based Fertility Awareness Training |
| Control group (n:40) | No intervention | Students will be trained for 2 hours using the classical method on the anatomy and physiology of the male and female reproductive systems, the physiology of pregnancy, fertility awareness development and its importance in terms of infertility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
It was prepared by the researchers after conducting a literature research and taking expert opinions. The form includes questions about the sociodemographic characteristics of the students.
Measured: 10 minutes
Ovarian Reserve Information Form
It was prepared by researchers after conducting a literature review and obtaining expert opinions. The form includes questions that evaluate students' knowledge and attitudes about ovarian reserve.
Measured: 10 minutes
Fertility Awareness Scale (FAS)
The Fertility Awareness Scale (FAS) is a Likert-type scale consisting of 19 items and two dimensions. There is no reverse item in the scale. The lowest score that can be obtained from the FAS is 19 and the highest score is 95. The range is 10-50 in the Physical Awareness sub-dimension and 9-45 in the Cognitive Awareness sub-dimension. As the total score obtained from the FAS increases, the level of awareness increases. When evaluating the total score obtained from the FAS; if the total score is between 19-43, awareness is scored as low, if it is between 44-69, awareness is scored as medium, and if it is between 70-95, awareness is scored as high. These values were determined according to the calculation of the score range average method. Cronbach's alpha internal consistency coefficient was determined as 0.887 for the total FAS scale.
Measured: 10 minutes
State-Trait Anxiety Inventory
This inventory, developed by Spielberger et al. (1970), consists of two subscales, state and trait, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how an individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how an individual feels independently of the situation and conditions they are in. The adaptation of the State and Trait Anxiety Inventory to Turkish, its validity and reliability study was conducted by Öner and Le Compte (1983).
Measured: 10 minutes
Secondary outcomes (3)
Ovarian Reserve Information Form
It was prepared by researchers after conducting a literature review and obtaining expert opinions. The form includes questions that evaluate students' knowledge and attitudes about ovarian reserve.
Measured: 10 minutes
Fertility Awareness Scale (FAS)
The Fertility Awareness Scale (FAS) is a Likert-type scale consisting of 19 items and two dimensions. There is no reverse item in the scale. The lowest score that can be obtained from the FAS is 19 and the highest score is 95. The range is 10-50 in the Physical Awareness sub-dimension and 9-45 in the Cognitive Awareness sub-dimension. As the total score obtained from the FAS increases, the level of awareness increases. When evaluating the total score obtained from the FAS; if the total score is between 19-43, awareness is scored as low, if it is between 44-69, awareness is scored as medium, and if it is between 70-95, awareness is scored as high. These values were determined according to the calculation of the score range average method. Cronbach's alpha internal consistency coefficient was determined as 0.887 for the total FAS scale.
Measured: 10 minutes
State-Trait Anxiety Inventory
This inventory, developed by Spielberger et al. (1970), consists of two subscales, state and trait, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how an individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how an individual feels independently of the situation and conditions they are in. The adaptation of the State and Trait Anxiety Inventory to Turkish, its validity and reliability study was conducted by Öner and Le Compte (1983).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-Based Fertility Awareness TrainingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541717
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-008
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 7 Aug 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midwifery Students' Ovarian Reserve and Fertility Awareness: Effectiveness of Video Intervention
- ClinicalTrials.gov ID
- NCT06541717
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-008
- Conditions
- Video-Based Fertility Awareness Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Aug 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 evaluate the effects of video-based ovarian reserve awareness training applied to midwifery students on ovarian reserve, fertility awareness and anxiety of midwifery students. The research population will consist of second-year students studying in the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBU) in the fall semester of 2024-2025 academic year (N: 80). In this study planned as a semi-experimental pre-test and post-test design with a control group, in order to determine the sample size; the data were normally distributed, the standard deviation of the main mass was estimated as 1 and the effect size (effect size, difference) was estimated as 0.8. For the analysis to be conducted, it was calculated that the highest power value of the study would be 0.942182 if two independent n₁=40, n₂=40 samples were taken at a significance level of 5%. The G-power analysis result is given below.
Students who volunteer to participate in the study will be assigned to the intervention and control groups with the computer-aided simple random sampling method. Computer-aided randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www.randomizer.org and random assignment will be made to the intervention and control groups. The study will be conducted single-blind. Midwifery students in the intervention group of the study will be given video-based ovarian reserve and fertility awareness training. A pre-training information meeting will be held with midwifery students who volunteered to participate in the study and were assigned to the intervention group. The midwifery students will be administered the "Ovarian Reserve Information Form", "Fertility Awareness Scale" and "State Anxiety Scale" before and after the training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group (n:40) | Experimental | Other: Video-Based Fertility Awareness TrainingStudents will be shown 3 15-minute videos created by researchers on the anatomy and physiology of the male and female reproductive systems, the physiology of pregnancy, fertility awareness development and its importance in terms of infertility. |
| Control group (n:40) | No intervention | –Students will be trained for 2 hours using the classical method on the anatomy and physiology of the male and female reproductive systems, the physiology of pregnancy, fertility awareness development and its importance in terms of infertility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be a volunteer to participate in the research.
- To be an active student in the 2nd year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
Key exclusion criteria (1 listed)
- Being a passive student in the 2nd year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
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 |
|---|---|---|
| Video-Based Fertility Awareness TrainingStudents will be shown 3 15-minute videos created by researchers on the anatomy and physiology of the male and female reproductive systems, the physiology of pregnancy, fertility awareness development and its importance in terms of infertility. | Other | İntervention group (n:40) |
Primary outcome
Introductory Information Form
Time frame: 10 minutes
It was prepared by the researchers after conducting a literature research and taking expert opinions. The form includes questions about the sociodemographic characteristics of the students.
Ovarian Reserve Information Form
Time frame: 10 minutes
It was prepared by researchers after conducting a literature review and obtaining expert opinions. The form includes questions that evaluate students' knowledge and attitudes about ovarian reserve.
Fertility Awareness Scale (FAS)
Time frame: 10 minutes
The Fertility Awareness Scale (FAS) is a Likert-type scale consisting of 19 items and two dimensions. There is no reverse item in the scale. The lowest score that can be obtained from the FAS is 19 and the highest score is 95. The range is 10-50 in the Physical Awareness sub-dimension and 9-45 in the Cognitive Awareness sub-dimension. As the total score obtained from the FAS increases, the level of awareness increases. When evaluating the total score obtained from the FAS; if the total score is between 19-43, awareness is scored as low, if it is between 44-69, awareness is scored as medium, and if it is between 70-95, awareness is scored as high. These values were determined according to the calculation of the score range average method. Cronbach's alpha internal consistency coefficient was determined as 0.887 for the total FAS scale.
State-Trait Anxiety Inventory
Time frame: 10 minutes
This inventory, developed by Spielberger et al. (1970), consists of two subscales, state and trait, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how an individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how an individual feels independently of the situation and conditions they are in. The adaptation of the State and Trait Anxiety Inventory to Turkish, its validity and reliability study was conducted by Öner and Le Compte (1983).
3 secondary outcomes
Ovarian Reserve Information Form
Time frame: 10 minutes
Fertility Awareness Scale (FAS)
Time frame: 10 minutes
State-Trait Anxiety Inventory
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Fertility Awareness Training in people with Video-Based Fertility Awareness Training, run by Saglik Bilimleri Universitesi 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 2 inclusion and 1 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 7 Aug 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?
Results are not available in the source record.
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?
Introductory Information Form (time frame: 10 minutes). The study lists 4 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 7 Aug 2024.