The Effect of Web-Based Education Specific to Sexual Health During Pregnancy on Sexual Life

February 13, 2025 updated by: Sule Gokyildiz Surucu, Cukurova University

Pregnancy is an important process with many changes in a woman's life. During this period, the sexual lives of couples may be affected due to anatomical, physiological and psychological changes. While sexual intercourse during pregnancy strengthens the harmony between spouses, emotional bond, and self-confidence of the woman, its role is important in terms of the continuation of the marriage.

The development of technology in the world and in our country has led to an increase in the use of mobile devices. The emergence of telehealth and mobile applications with the Covid-19 pandemic has enabled individuals to access information whenever they want and more easily.

The aim of this study was to determine the effect of mobile application support given to pregnant women for sexual health on sexual function and quality of sexual life.

It is planned to develop a mobile application in this direction by preparing a guide, with the foresight that sexuality during pregnancy is not an easily expressed subject and that pregnant women and health workers need training materials. After the power analysis, it is aimed to reach a total of 70 people, 35 in the experimental group and 35 in the control group. Data will be collected with Personal Information Form, Female Sexual Function Index, Sexual Life Quality Scale and Qualitative Interview Form.

Based on the developed guide and mobile application, training will be given to pregnant women in the first, second and third trimesters, and it is thought that the mobile application support specific to sexual health during pregnancy may contribute to increasing sexual function and sexual life quality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

This thesis study was designed to determine the effect of mobile application support given to pregnant women for sexual health on sexual function and quality of sexual life. In this thesis, it is planned to develop a mobile application in this direction by preparing a guide, with the foresight that sexuality during pregnancy is not an easily expressed subject and that pregnant women and health workers need training materials on this subject. Based on the developed guide and mobile application, it is thought that by providing continuous training to pregnant women, it can contribute to increasing women's sexual function and sexual life quality.

Research Hypotheses

  • H0 a: Mobile application support for sexual health during pregnancy has no effect on sexual function.
  • H1 a: Mobile application support specific to sexual health during pregnancy has an effect on sexual function.
  • H0 b: The mobile application support for sexual health during pregnancy has no effect on the quality of sexual life.
  • H1 b: Mobile application support specific to sexual health during pregnancy has an effect on the quality of sexual life.

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 (Estimated)

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.
70

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 Contact Backup

Study Locations

  • Turkey
      • Adana, Turkey
        • Cukurova 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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In the first 3 months of pregnancy
  • Speaks and understands Turkish
  • Being able to read and write
  • Not having received prior education about sexuality during pregnancy

Exclusion Criteria:

  • Having a risky pregnancy (under 18 years of age, having a chronic and psychiatric disease, etc.)

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: Prevention
  • 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: Mobile Application Support Specific to Sexual Health in Pregnancy
The training module will consist of 3 sessions. The first session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. The second and third sessions will last 1 hour, with 45 minutes of interactive narration and 15 minutes of qualitative interviews. Module sessions will have a dynamic structure that takes into account the needs of the pregnant woman in her trimester. The content of the training sessions will be structured on the following topics.
Other: Education
Sexual Health in Pregnancy
No Intervention: control
No training will be given to the pregnant women in the control group who accepted to participate in the study.

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
Female Sexual Function Index
Time Frame: Change in sexual functions during pregnancy at 9 months
It was developed as a 19-item multidimensional scale to evaluate female sexual function. The scale assesses sexual problems or function in the last 4 weeks. In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0, and the lowest raw score is 4.0.
Change in sexual functions during pregnancy at 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sexual Quality of Life Scale
Time Frame: Change in the quality of sexual life in 9 months of pregnancy
The scale is easy to apply, six-point Likert type, which individuals can answer on their own, and consists of 18 items. It is expected that each item will be answered considering his sexual life in the last four weeks. In scoring the scale, each question is scored between 1-6. In this system, it will be scored as (1=Strongly Agree, 2=Strongly Agree, 3=Partly Agree, 4=Somewhat Disagree, 5=Strongly Agree, 6=Strongly Disagree). In this way, the range of points that can be obtained from the scale is between 18-108.
Change in the quality of sexual life in 9 months of pregnancy

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.
Cukurova 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 Director: Şule GÖKYILDIZ SÜRÜCÜ, Prof., gokyildizsule@gmail.com
  • Principal Investigator: Emel SALCAN, Msc.Midwife, emelers@hotmail.com

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.
September 9, 2024

Primary Completion (Estimated)

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 30, 2025

Study Completion (Estimated)

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.
August 31, 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).
June 6, 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 12, 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.
July 20, 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.
March 25, 2025

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.
February 13, 2025

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.
February 1, 2025

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.
  • 04.11.2022/38

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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