Sexual Education in Women Based On The Plissit Model On Awareness And Attitude in Midwifery Students

July 21, 2023 updated by: yasemin hamlacı başkaya, Sakarya University

The Effect of Sexual Education in Women With Gynecological Cancer Based On The Plissit Model On Awareness And Attitude in Midwifery Students: A Randomised Controlled Study

In this study, it was aimed to determine the awareness levels and attitudes of the students with the sexual counseling training conducted in line with the PLISSIT model. This experimental (randomized-controlled) study was conducted with midwifery students who agreed to participate in the study and met the inclusion criteria at a state university in western Turkey. As a result of the randomization, there were 38 students in the intervention group and 36 students in the control group. While training based on the PLISSIT framework was given to the intervention group, no training was given to the control group. Data were collected through the Introductory Information Form, the Gynecological Cancer Awareness Scale (GCPS), and the Sexual Attitudes and Beliefs Scale (CTİÖ) before the training and after the completion of the 3 trainings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intervention In order to improve the educational content, researchers conducted a literature review on gynecological cancers, sexual problems in gynecological cancer, sexual counseling. The training content was created after the literature review.

Gynecological cancers are malignant diseases of the ovaries, cervix, endometrium, vulva, vagina and fallopian tubes that make up the female reproductive system. GLOBACAN (Global Cancer Observatory) 2020 data show that gynecological cancers rank fourth among the most common types of cancer among women in the world. Gynecological cancers are responsible for more than 100,000 incidences and 32,000 deaths per year. Significant changes are taking place, especially in the area of sexuality. It is known that sexually active gynecological cancer cases often complain of dyspareunia, vaginal dryness, postcoital bleeding, deterioration in sexual arousal, lack of sexual desire, genitopelvic pain. In addition, changes in the female genital organs, such as vaginal stenosis, vaginal dryness, scar formation in the vagina and vaginal atrophy, can lead to sexual dysfunction. Sexual dysfunction is one of the most common and troubling qualities of life issues faced by women with gynecological cancer, but it is rarely discussed among cancer patients, survivors, and health professionals. Therefore, a comprehensive assessment of sexual health from the first visit of patients should be carried out as a routine part of each examination. In this regard, health professionals need to apply resources that will encourage effective, sensitive, communication with patients about sexual health problems. One of the most widely used interventions in the field of assessing and managing sexual problems is the PLISSIT model. The PLISSIT model provides a safe, tolerant and therapeutic environment for the discussion of sexual concerns, encouraging referral to an appropriate specialist as needed. The model consists of four steps to address sexual concerns: Consent, Limited Information, Specific Recommendations, and Intensive Therapy. The first stage of this model is to allow patients to share their thoughts and concerns about their sex life. In the second stage, individuals are informed about their thoughts and concerns about their sex life. In the third stage, patients are given "special recommendations". Specific recommendations should be appropriate to each person's individual needs. At this point, health professionals need to know more about sexuality in order to give patient-specific information. The fourth stage involves the referral of the patient to the relevant specialist. This model enables healthcare professionals to develop effective strategies for addressing sexual concerns. In order for the model to be applied effectively, it is essential that the relevant health professionals are informed about the subject. In this context, it is very important to show health professionals and students studying in the field of health that sexuality is very important in women with gynecological cancer, to raise their awareness in the field and to ensure that their positive attitudes towards sexuality are formed. For this reason, in this study, 3rd-year students of the midwifery department were trained on "sexuality education for women with gynecological cancer" prepared based on the PLISSIT model, and it was examined how the gynecological cancer awareness and sexual attitudes and beliefs of the students were affected.

In this study, it is aimed to determine the effect of sexuality education in line with the PLISSIT model on the gynecological cancer awareness levels of the students and their sexual attitudes and beliefs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sakarya, Turkey
        • Sakarya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a midwifery 3rd year student,
  • Agree to participate in the study.

Exclusion Criteria:

-Having failed or not taken the "Gynecology" course even though it is a third year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group

Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.

Questionnaires (Introductory individual form, Gynecological cancer awareness scale and Sexual Attitudes and Beliefs Scale) were completed by students included in the intervention and control groups at the beginning and one month after the completion of the 3 training sessions.
Other: Education based on the PLISSIT model
Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.
No Intervention: Control group
The students in the control group were not given any training within the scope of the study, and they only had knowledge about gynecological cancers and sexuality, which are included in the course content of gynecological diseases. However, in order to comply with ethical principles, training information was provided online to the control group after the study data collection process was completed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gynecological cancer awareness scale change
Time Frame: pre-intervention, 1 month after intervention
Scale; It consists of four sub-dimensions: routine control and awareness of serious disease perception in gynecological cancers, awareness of gynecological cancer risks, awareness of prevention from gynecological cancers and early diagnosis and information awareness in gynecological cancers.
pre-intervention, 1 month after intervention
Sexual Attitudes and Beliefs Scale Change
Time Frame: pre-intervention, 1 month after intervention
high scores from scale items and grand total; It shows that negative beliefs and attitudes towards evaluating the patient's sexuality/providing sexual counseling increase and there are more obstacles in evaluating sexual problems and providing counseling.
pre-intervention, 1 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sakarya University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ahsen DEMİRHAN KAYACIK, Sakarya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 03072023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Cancer

Clinical Trials on Education based on the PLISSIT model

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings