Evaluation of Sexual Health Counseling for Primiparous Pregnant Women Using PLISSIT Model and Motivational Interviewing

April 22, 2025 updated by: Özlem SEYMEN, Tokat Gaziosmanpasa University

Evaluation of Structured Sexual Health Counseling for Primiparous Pregnant Women Based on PLISSIT Model Supported by Motivational Interviewing

This study is a simple randomized controlled intervention study to evaluate the effects of sexual counseling given to primiparous pregnant women using motivational interviewing on sexual self-efficacy, attitude towards sexuality and quality of sexual life.

HO: There is no difference between the mean Sexual Function Scale score in the last evaluation of pregnant women in the intervention and control groups.

H0a: There is no difference between the mean Sexual Self-Efficacy Scale score in the last evaluation of pregnant women in the intervention and control groups.

H0b: There is no difference between the mean Attitude Towards Sexuality During Pregnancy Scale score in the last evaluation of pregnant women in the intervention and control groups.

H0c: There is no difference between the mean Sexual Life Quality Scale score in the last evaluation of pregnant women in the intervention and control groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

Pregnancy is a natural process that involves hormonal, physical, and social changes, affecting a woman's mood, relationships, and sexual life. The first pregnancy is a significant transition period, during which women may experience various fears related to sexuality, such as fear of miscarriage, premature birth, harming the baby, or increased risk of infection. These concerns often lead to a decrease in sexual activity during pregnancy.

The PLISSIT Model is suggested as an effective approach for assessing sexual health during pregnancy. This model consists of four stages: permission for expressing thoughts and concerns about sexuality, providing limited information, offering specific suggestions, and referring to intensive therapy when necessary. Additionally, the motivational interviewing method can help pregnant individuals recognize conflicting emotions and make positive behavioral changes.

Research indicates that sexual knowledge impacts sexual function, and participation in educational programs can improve sexual health during pregnancy. However, studies also show that healthcare professionals often lack sufficient support in this area. Nurses play a crucial role in educating and counseling pregnant women to enhance their awareness of sexual health. The absence of sexual health recommendations in the Ministry of Health's prenatal care guidelines highlights a gap in this area. Improving sexual quality of life during pregnancy is essential for strengthening women's self-confidence and sense of adequacy.

In the study, the data collection tools used were the **Inclusion Criteria Questionnaire (ICQ), Personal Information Form, Sexuality Diary, Female Sexual Function Index (FSFI), Sexual Self-Efficacy Scale (SSES), Attitudes Towards Sexuality During Pregnancy Scale (ATSPS), and Sexual Quality of Life Questionnaire-Female Version (SQOL-F).**

  • **ICQ:** A ten-item form assessing the eligibility criteria for pregnant participants. Women who scored below 26.55 on the FSFI and answered all questions as "yes" were included in the study.
  • **Personal Information Form:** A 15-item form assessing the socio-demographic and obstetric characteristics of pregnant individuals.
  • **FSFI:** A scale evaluating female sexual function. A score below 26.55 indicates female sexual dysfunction.
  • **SSES:** A scale measuring individuals' sexual self-efficacy, ranging from 0 to 40. Higher scores indicate higher sexual self-efficacy.
  • **ATSPS:** A 34-item Likert-type scale assessing attitudes toward sexuality during pregnancy. Higher scores indicate a more positive attitude. The cutoff point is set at 111.5.

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
      • Ankara, Turkey
        • Ankara Yıldırım Beyazıt 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:

  • Those over 19 years of age
  • Those in their first pregnancy
  • Those in their 8th-16th weeks of pregnancy
  • Those who are sexually active
  • Those who have a score of less than 26.55 on the Female Sexual Function Scale (FSFI)

Exclusion Criteria:

  • Those who have given birth prematurely
  • Those who have developed a pregnancy complication that prevents coitus at any stage of the study (placenta previa, preterm premature rupture of membranes)
  • Those who do not comply with the study plan
  • Those who have received any sexual counseling
  • Those who have experienced a life crisis (death of partner, divorce, moving, etc.)
  • Those who want to withdraw from the study at any stage of the study

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: Double

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: Intervention group (pregnant women receiving sexual counselling)
In the intervention phase of the study, sexual counseling based on the PLISSIT model supported by motivational interviewing will be provided. The average duration of each counseling session is planned to be 60 minutes.
Behavioral: control group
Only surveys will be filled out.
No Intervention: Control Group (pregnant women not receiving sexual counselling)
Scales and forms for the control group will be completed at the end of the second and fourth weeks.

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 Scale
Time Frame: 5 weeks
The Female Sexual Function Scale will be used to evaluate the sexual functions of pregnant women. The total score that can be obtained from the scale is between a minimum of 2 and a maximum of 36 points. Increasing scores indicate a good level of sexual function. If the total KCFI score is 30 and above, the sexual function level is defined as "good", between 23-29 points as "medium", and less than 23 points as low, and the cut-off value of the scale is 26.55. A total KCFI score of 26.55 and below indicates that the level of sexual function is inadequate.
5 weeks

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 Self-Efficacy Scale
Time Frame: 5 weeks
will be used to determine the sexual self-efficacy levels of pregnant women. The scale is one-dimensional. The lowest score that can be obtained from the scale is 0, the highest score is 40. High scores indicate a high level of sexual self-sufficiency belief.
5 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attitude Towards Sexuality During Pregnancy Scale (
Time Frame: 5 weeks
It will be used to evaluate pregnant women's attitudes towards sexuality during pregnancy. The lowest possible total score from the Attitudes Towards Sexuality During Pregnancy Scale was calculated as 34 and the highest as 170. An increase in the total score from the GCCTS indicates that attitudes towards sexuality during pregnancy are positive, while a decrease in the total score indicates that attitudes towards sexuality during pregnancy are negative.
5 weeks
Sexual Life Quality Scale-Female Version
Time Frame: 5 weeks
It will be used to evaluate the Sexual Life Quality of pregnant women. The range of scores that can be obtained from this scale varies between 18-100. Before calculating the total score of the scale, the scores of items 1, 5, 9, 13, 18 must be reversed. Increasing scores from the scale indicate that the quality of sexual life has also increased.
5 weeks

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.
Tokat Gaziosmanpasa 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.
Ankara Yildirim Beyazıt 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.
March 15, 2025

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.
May 15, 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.
June 30, 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).
February 10, 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.
March 3, 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.
March 6, 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 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.
April 22, 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.
April 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.
  • GaziosmanpasaU-OS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Supporting information: CSR

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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