Online Interactive Video Developed for Fertility Awareness

NCT06460428 | Not Yet Recruiting

• 1 other identifier: GaziU-Hem-ŞYS-08
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this research is to evaluate the effect of online interactive education provided to newly married couples via a web-based platform on fertility awareness.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. These studies are generally given to women. But the concept of fertility in question concerns not only women but also men.The study conducted via web-based online interactive video developed to raise awareness about fertility; It is thought that raising the awareness of newly married couples, regulating fertility, and including men in this issue are important for public health and will set an example for future studies.The positive outcomes from Webb-based online videos will enable the application to be used on national and international platforms.

Conditions

Fertility Awareness

Keywords

Fertility awareness, Pre-wedding period, Web-based education

Outcome Measures

Primary Outcomes (2)

• Fertility Awareness Scale

  Fertility Awareness Scale is a 19-item, five-point Likert type (1-Never, 2-Rarely, 3-Sometimes, 4-Often, 5-Always), two-dimensional scale: Body Awareness Sub-Dimension 7,9,10, 11,12,13,15,17,18,19 (10 items) and Cognitive Awareness Sub-Dimension 1,2,3,4,5,6,8,14,16 (9 items). There are no reverse items in the scale. The lowest score that can be obtained in the total of the Fertility Awareness Scale is 19 and the highest score is 95. As the total score from the Fertility Awareness Scale increases, the level of awareness increases. If the total score is between 19-43, awareness is classified as low, between 44-69, awareness is classified as medium, and between 70-95, awareness is classified as high level.

  3 months

• Fertility Health Information Scale

  Fertility Health Information Scale includes biological information regarding gender-specific reproductive health (menstrual cycle, sperm survival and quality, ability to have an erection), non-modifiable (age) and modifiable (lifestyle choices such as weight, stress, marijuana and cigarette use). /exposure) related to healthy fertility, It includes statements about factors such as stress, caffeine, diet, exercise, sleep habits, etc.). The scale consists of 30 items and has a single-factor structure. Responses to the items related to the scale are on a five-point Likert type (5-definitely yes; 4-probably yes; 3-undecided; 2-probably no; 1-definitely no). Those who choose "definitely yes" or "probably yes" are considered correct. In the evaluation, item 20 is reverse coded. Scores between 0 and 30 points can be obtained from the scale, and as the score increases, knowledge increases.

  3 months

Study Arms (2)

Active Comparator: 1. group

EXPERIMENTAL

Couples in the pre-wedding period will receive information about fertility awareness with the developed interactive video

Behavioral: Interactive video usage

No Intervention: 2. Group

NO INTERVENTION

Control Group (non- education): No intervention will be made

Interventions

Interactive video usage BEHAVIORAL

The implementation of the research was carried out in two stages. In the first stage, interactive videos were created, in the second stage, the experimental group was trained with interactive videos, and no intervention was made to the control group.

Active Comparator: 1. group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being over 18 years of age
• Having applied for official marriage
• First marriage
• Must be at least a primary school graduate

You may not qualify if:

• Not knowing Turkish
• Having any communication problems (mental, auditory, visual, etc.)
• Having previously received preconception training/care
• There is less than 2 weeks between the marriage ceremony and the marriage application date.
• For female participants;
• Having had previous pregnancy or birth experience
• Having been diagnosed with menopause
• Inaccessibility of the study at any stage
• Wanting to leave work
• Completion of training
• Not completing post-tests

Sponsors & Collaborators

• Gazi University: lead

Study Officials

• Şengül Yaman Sözbir

  Head of Department of Obstetrics and Gynecology Nursing, Gazi University

  STUDY DIRECTOR

Central Study Contacts

Tenzile Hergül

CONTACT

+905383019593; tenzilehergul95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In order to prevent selection bias and to ensure similarity between groups; simple randomization will be used to assign the couples in the sample group to the experimental and control groups. In this study, researcher and participant blinding will not be performed. Because the researcher will do the intervention himself/herself and placebo will not be used in the intervention. Data collection forms to prevent detection bias will be applied online through Google Forms® independently of the researcher. The data obtained from the research to prevent reporting bias will be transferred to the SPSS program by an independent researcher. Analysis of the data will also be done by an independent statistician.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This research is a randomized controlled experimental study with a pretest-posttest control group.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 24, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share