- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06690554
Health Promotion Model, Fertility Awareness, Preconception Knowledge and Attitude
The Effect of Education Given to Preconception Women in Line with the Health Promotion Model on Fertility Awareness, Preconception Knowledge and Attitude Levels
Study Overview
Status
Intervention / Treatment
Detailed Description
The research is a randomized controlled trial. The research will conducted with 128 women (intervention group n=64, control group n=64). It will consist of women between the ages of 18-35 who applied to the community health unit of Güneysınır District Health Directorate between December 2024-May 2025.
Women who accept the research and are assigned to the intervention group will be given a five-day training to increase fertility awareness and preconceptional knowledge levels in line with the health promotion model. At the end of the fifth day, the Fertility Awareness Scale, Preconceptional Knowledge and Attitude Scale, and the Clinical Evaluation Form of the Health Promotion Plan for the Health Promotion Model will be applied to women who complete the training with a face-to-face interview technique. The women in the intervention group will be reached by phone at the end of the first and second months to remind them of their health promotion behaviors and to answer their questions and carry out follow-ups. At the end of the third month, women who have completed the training will be invited to the institution and the forms will be filled out again.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey, 42250
- Seyhan Çankaya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women between the ages of 18-35,
- Planning to get pregnant within a year,
- Literate,
- Can understand and speak Turkish,
- Agree to participate in the research.
Exclusion Criteria:
- Women who are pregnant,
- Women who are breastfeeding,
- Women who have been diagnosed with infertility,
- Women who have a history of chronic disease (hypertension, diabetes mellitus, hypothyroidism, etc.),
- Women who have a sexually transmitted disease (HIV, HPV, etc.),
- Women who have a physical disability,
- Women who have a psychiatric disease,
- Women who have a history of gynecological disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Placebo group
|
|
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Experimental: Education Group
Women will be given a five-day training in line with the health promotion model.
|
Women will be given a five-day training in line with the health promotion model. Information will be provided to women who apply to the hospital. Written consent documents will be obtained from women who agree to participate in the study. Women assigned to the intervention group will attend classes in groups of 8-10. Women will be given a 60-minute training once a day for five days. The total training duration is five hours. Scales will be applied to women who complete the training at the end of the fifth day. Women who have completed the training will be contacted by phone at the end of the first and second months, reminded of health promotion behaviors and their questions will be answered and follow-ups will be carried out. At the end of the third month, women who have received training will be invited to the institution and the Fertility Awareness, Preconceptional Knowledge and Attitude will be filled out face-to-face for the final test. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of sociodemographic of women
Time Frame: 4 months
|
Sociodemographic of women will be collected through surveys and compared and reported
|
4 months
|
|
Comparison of obstetric features of women
Time Frame: 4 months
|
Obstetric features of women will be collected through surveys and compared and reported
|
4 months
|
|
Comparison of women's fertility awareness scale average scores by groups
Time Frame: 4 months
|
The fertility awareness scale will be applied to women.
The fertility awareness scale is 19-95 points (min-max), and as the score increases, fertility awareness scale increases.
|
4 months
|
|
Comparison of women's preconceptional knowledge and attitude scale average scores by groups
Time Frame: 4 months
|
Preconceptional knowledge and attitude scale will be applied to women.
The preconceptional knowledge and attitude scaleis 43-215 points (min-max), and as the score increases, preconceptional knowledge and attitude increases.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seyhan Çankaya, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/1011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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