The Effectiveness of Virtual Patient Simulation Versus Peer Simulation in Providing Sexual Counseling During Pregnancy

April 29, 2026 updated by: NESLİHAN YILMAZ SEZER, Ankara University

The Effectiveness of Virtual Patient Simulation Versus Peer Simulation in Enhancing Attitudes, Beliefs, and Skills in Providing Sexual Counseling During Pregnancy

The aim of this study is to compare, in a multidimensional manner, the effectiveness of different educational methods-virtual patient simulation and peer simulation-in improving sexual counseling skills during pregnancy among nursing faculty students.

The study will evaluate three different training methods: virtual patient simulation, peer simulation conducted in a virtual environment, and face-to-face peer simulation. To determine the effectiveness of peer simulation and virtual patient simulation in sexual health counseling, multimodal data collection and analysis methods will be used. These methods will contribute to the development of counseling skills by examining in detail the verbal and non-verbal communication elements exhibited by participants during their interactions with virtual patients and peers. Throughout the research process, students' demographic characteristics, sexual attitudes and beliefs, sexual counseling skills, learning satisfaction and self-confidence levels, opinions on system usability, eye-tracking data, and body movements will be analyzed.

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.

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.
51

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Altındağ
      • Ankara, Altındağ, Turkey (Türkiye), 06230
        • Ankara University Faculty of Nursing

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:

  • Having the ability to provide care for pregnant women - Providing informed consent to participate in the study

Exclusion Criteria:

  • Having suspended enrollment or taken a leave of absence from education.
  • Having received formal education aimed at developing sexual counseling skills.
  • Wearing glasses (as it may interfere with the use of wearable eye-tracking systems).

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: Single

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: virtual patient simulation group
Other: virtual patient simulation
Students in this group are expected to provide sexual counseling to a virtual patient model following theoretical training. In this context, a virtual patient model has been developed with whom the students will engage for the counseling process.
Experimental: peer simulation conducted in a virtual environment group
Other: peer simulation conducted in a virtual environment
Students in this group are expected to provide sexual counseling to their peers in a virtual environment following theoretical training. In the virtual peer simulation, students will see the same background displayed in the virtual patient simulation; however, instead of interacting with a virtual patient, they will connect with a peer via an online platform to conduct the counseling session.
Experimental: face-to-face peer simulation group
Other: face-to-face peer simulation
Students in this group are expected to provide sexual counseling to their peers following theoretical training. In the peer simulation, students will conduct their sessions in a communication skills laboratory designed to resemble a clinical consultation room.

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
Sexual Attitudes and Beliefs
Time Frame: immediately before the training-immediately after the training
Students' sexual attitudes and beliefs will be assessed using the the sexual attitudes and belief survey. This scale is a six-point Likert-type scale, with scores ranging from a minimum of 12 to a maximum of 72. Higher scores indicate more negative attitudes and beliefs toward sexual care.
immediately before the training-immediately after the training
Learning Satisfaction and Self-Confidence
Time Frame: immediately after the training
Learning satisfaction and self-confidence will be measured using the Student Satisfaction and Self-Confidence in Learning Scale. This scale is a five-point Likert-type scale, with responses ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores reflect greater student satisfaction and self-confidence in learning.
immediately after the training
Sexual Counseling Skills
Time Frame: During simulation
Students' sexual counseling skills will be assessed using the Sexual Counseling Skills Assessment Form. This form is developed based on the BETTER, PLISSIT, Ex-PLISSIT, and One-to-One models, and it covers the entire counseling process from initiation to conclusion. Each item is scored as 0 (not demonstrated) or 1 (demonstrated). The total score ranges from 0 to 34, with higher scores indicating a higher level of skill. The form will be completed while students simulate their counseling skills.
During simulation
System Usability Opinions
Time Frame: immediately after the training
Students' opinions regarding system usability will be assessed using the System Usability Scale (SUS). The SUS is a 10-item instrument scored on a five-point Likert scale. Scores range from a minimum of 10 to a maximum of 100. Higher scores indicate higher perceived usability of the system.
immediately after the training
Eye Tracking
Time Frame: During simulation
Eye tracking parameters in the study will be assessed using a wearable eye-tracking system. This device will analyze the areas of focus during students' interactions with virtual patients and peers. The analysis of gaze points and eye movements will help evaluate the distribution of attention during communication.
During simulation
Body Movements
Time Frame: During simulation
Body movements will be evaluated using a motion tracking device. These motion detection systems will analyze body language to assess participants' capacity to establish effective connections with virtual patients and peers. This method aims to evaluate participants' ability to use gestures and body language effectively to build strong relationships with patients.
During simulation

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.
Ankara University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Delaware

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.
April 28, 2025

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.
June 27, 2025

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.
June 27, 2025

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).
April 22, 2025

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.
April 22, 2025

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.
April 29, 2025

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.
April 30, 2026

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.
April 29, 2026

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.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 03.03.2025/05-87

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.

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