NCT06690554

Brief Summary

The effect of education given to preconceptional women in line with the health promotion model on fertility awareness, preconceptional knowledge and attitude levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 20, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 13, 2024

Last Update Submit

March 19, 2025

Conditions

Keywords

Fertility AwarenessPreconceptional Knowledge and AttitudeHealth Promotion Model

Outcome Measures

Primary Outcomes (4)

  • Comparison of sociodemographic of women

    Sociodemographic of women will be collected through surveys and compared and reported

    4 months

  • Comparison of obstetric features of women

    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

    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

    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

Study Arms (2)

Placebo group

NO INTERVENTION

* Information about the research will be provided. * Written consent will be obtained. * Personal Information Form, Fertility Awareness, Preconceptional Knowledge and Attitude will be applied to women who accept to participate in the research. * Five days after the first interview, women will be reached and the scales will be applied. * Three months after the first interview, women will be reached, invited to the institution and the scales will be applied again.

Education Group

EXPERIMENTAL

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.

Other: Education Group

Interventions

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.

Education Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyhan Çankaya

Konya, Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

InfertilityPreconception InjuriesHealth BehaviorBehavior

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesDisorders of Environmental Origin

Study Officials

  • Seyhan Çankaya

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 15, 2024

Study Start

November 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 20, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations