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

Active, not recruiting

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

70

Phase

  • 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

      • 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

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
Intervention / Treatment
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.
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

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

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

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.

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)

March 15, 2025

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID 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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