NCT05544851

Brief Summary

Sexually transmitted infections (STIs) are an important public health problem as they affect more than 1 million people worldwide every day. The extent of sexually transmitted diseases is still unknown due to underreporting, underdiagnosis or asymptomatic course of these diseases. When the literature is examined, it is seen that the incidence of STD has increased in recent years. The prevalence of premarital sexual intercourse as a result of the decrease in the age of sexual maturity but the increase in the age at marriage in general plays an important role in this increase. It is estimated that 46.8 million of 450 million people in the 15-49 age group living in the European region, including Turkey, have treatable STIs. STD can lead to many serious health problems such as infertility, ectopic pregnancy, cancer, chronic pelvic pain, pelvic adhesions and even death. Moreover, eye diseases, central nervous system infection and death may occur in the baby of an infected mother. In the report of the "Study on Sexual and Reproductive Health in Young People" conducted in Turkey in 2007, it was determined that young people do not have sufficient information about the reproductive organs, structure and physiology, health problems that may arise due to STD, HIV/AIDS, and ways of protection (6).An effective education; can significantly affect the quality of care, personal safety and satisfaction. One of the most effective and successful methods used in education is the Teach-Back method. Tell What You've Learned is a communication and education method used in health education for patients to remember and understand important information about diagnosis, treatment, medications or care. Tell What You've Learned is explained as a method that can be easily used for almost any interaction between healthcare team members and patients and can strengthen team understanding. It is recommended that all personnel, not only clinical caregivers, should use the method effectively in the health care system. It is stated that the conceptual framework of this method is based on the individuals receiving health services to present the information by arranging them according to themselves. It is considered as an effective method in terms of determining whether the transferred information is understood correctly. It is stated that 40-80% of the individuals who consult or immediately forget the information given to them about their health. Various factors that cause communication problems between healthcare professionals and clients during information transfer affect the clarity and permanence of the information given.The "Tell What You Have Learned" method is also expressed as closing the loop, and it is reported to be an effective method when used to eliminate the communication gap between healthcare professionals and service recipients. In addition, it is stated that the use of the method to control the materials (educational brochure, training guide, etc.) used by individuals leaving the hospital to access health information will have a positive effect on health outcomes. From another point of view; It is predicted that it will increase the health literacy rate, and it is accepted as a research-based health literacy intervention that enriches the communication between the health care provider and the service recipient, improves the health outcomes of the individual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

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

December 7, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

December 7, 2021

Last Update Submit

March 5, 2024

Conditions

Keywords

reproductive ageSexually Transmitted DiseaseWomen Health

Outcome Measures

Primary Outcomes (1)

  • The importance of education

    Data collection stages: Participants who meet the sample selection criteria will be informed about the scope of the study and their verbal and written consent will be obtained. Women who met the sample selection criteria and were accepted into the study group will be randomly assigned to the intervention and control groups. Personal Information Form, "Behaviors for Protection from Sexually Transmitted Diseases Scale" will be applied to the participants in the intervention and control groups. HTA training will be applied to the intervention group with the tell what you learned method, and clinical routines will be applied to the control group. The maximum score to be taken from the scale is 105, the minimum score is 21.The scale used scores the behaviors of the participants. Participants with low scores have deficiencies in behaviors towards protection from sexually transmitted diseases. After the training is given to the participants, their repetitive behavior will be measured.

    12 months

Study Arms (2)

Educated Reproductive Women

EXPERIMENTAL

Inclusion Criteria / Patient Women of reproductive age (range 18-49 years) No history of STD, literate, Ability to understand and answer questions Those who have not received training on STDs before, Exclusion Criteria from Research Getting training on STDs before Absence from education for at least two sessions, Women with a history of STD (HIV, HPV, etc.) disease will be excluded from the study.

Other: Education

Non-Educated Reproductive Women

EXPERIMENTAL

Inclusion Criteria / Patient Women of reproductive age (range 18-49 years) No history of STD, literate, Ability to understand and answer questions Those who have not received training on STDs before, Exclusion Criteria from Research Getting training on STDs before Absence from education for at least two sessions, Women with a history of STD (HIV, HPV, etc.) disease will be excluded from the study.

Other: Education

Interventions

Participants who meet the sample selection criteria will be informed about the scope of the study and their verbal and written consent will be obtained. Women who met the sample selection criteria and were accepted into the study group will be randomly assigned to the intervention and control groups. Personal Information Form, "Behaviors for Protection from Sexually Transmitted Diseases Scale" will be applied to the participants in the intervention and control groups.

Educated Reproductive WomenNon-Educated Reproductive Women

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsReproductive women between 18-49
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age (range 18-49 years)
  • No history of STD, literate,
  • Ability to understand and answer questions
  • Those who have not received training on STDs before,

You may not qualify if:

  • Getting training on STDs before
  • Absence from education for at least two sessions,
  • Women with a history of STD (HIV, HPV, etc.) disease will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Unıvercıty

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Feride Yiğit

    Hasan Kalyoncu Unıvercıty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Inclusion Criteria / Patient Women of reproductive age (range 18-49 years) No history of STD, literate, Ability to understand and answer questions Those who have not received training on STDs before, Exclusion Criteria from Research Getting training on STDs before Absence from education for at least two sessions, Women with a history of STD (HIV, HPV, etc.) disease will be excluded from the study.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Inclusion Criteria / Patient Women of reproductive age (range 18-49 years) No history of STD, literate, Ability to understand and answer questions Those who have not received training on STDs before, Exclusion Criteria from Research Getting training on STDs before Absence from education for at least two sessions, Women with a history of STD (HIV, HPV, etc.) disease will be excluded from the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 7, 2021

First Posted

September 19, 2022

Study Start

October 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 30, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations