NCT06639269

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

October 9, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

October 9, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

youtheducationFertility Health InformationHealthy Life Awareness

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 months

Study Arms (2)

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.

Other: fertility health education program

Interventions

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.

Also known as: fertility health education, education program
educational program intervention group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University, Naci Topçuoğlu Vocational School

Gaziantep, Şehitkamil, 27600, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Funda Ozdemir, Assoc. Prof.

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
REGISTERED NURSE, PhD student

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

October 14, 2024

Primary Completion

December 13, 2024

Study Completion

December 14, 2024

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations