The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes Towards Sexuality and Sexual Distress in Pregnant Women (Pregnant Women)

July 28, 2024 updated by: Esma Demirezen, Istanbul University - Cerrahpasa (IUC)

The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women

Purpose of the study: In the light of these data, the effect of sexual health education based on the PLISSIT model on sexual function, attitude towards sexuality and sexual distress in nulliparous pregnant women will be examined in a randomized controlled experimental study. It is thought that the data to be obtained will shed light on sexual health education and counseling practices for midwives working with pregnant women in their application areas.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Effect of Sexual Education Based on the PLISSIT Model on Sexual Function, Attitudes towards Sexuality and Sexual Distress in Pregnant Women

Method of the study: FSFI will be applied to pregnant women between 14-20 weeks of gestation who apply to Trakya University Health Research and Application Center Obstetrics Clinic, Polyclinic and Perinatology Clinic departments, and women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction. Pregnant women will be randomized according to the last digit of their protocol number. Pregnant women divided into control and intervention groups will be given PLISSIT model-based sexual health education to the intervention group and a clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again.

Study Type

Interventional

Enrollment (Estimated)

180

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

  • Turkey
      • Istanbul, Turkey, 34320
        • Istanbul University-Cerrahpaşa

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

Accepts Healthy Volunteers

Yes

Description

inclusion criteria: Volunteer to participate, 19 years of age and over, sexually active, at least primary school graduate, of Turkish origin, no communication problems, 14th-20th age, fluent in Turkish. Pregnant women in their 2nd week will be included in the study.

exclusion criteria: Pregnant women who are at serious risk during pregnancy, who are diagnosed with sexual dysfunction, who have mental problems that require treatment, and who use drugs that cause sexual dysfunction will not be included in the study Pregnant women who leave their information forms unfinished, experience loss, and want to leave the study will be excluded.

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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
Intervention / Treatment
Experimental: Experimental: Intervention Group
PLISSIT model-based sexual health education will be provided to the intervention group, and the clinical procedure will be applied to the control group. The Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered simultaneously. Four weeks after the training, the FSFI application and the Sexual Attitude Scale during Pregnancy and the Female Sexual Distress Scale will be administered again
Behavioral: PLISSIT model based sexual health education
the PLISSIT model includes the steps of PLISSIT (P-Permission), LI-Limited Information, SS-Specific Suggestions, IT-Intensive Therapy. This model provides communication with the patient and Since it is a model that increases confidence and provides care interventions based on the patient's preference, it has the feature of guiding sexual education during pregnancy by establishing the bond between the pregnant woman and the midwife.
Placebo Comparator: Kontrol Group
The clinical procedure will be applied to the control group
Behavioral: PLISSIT model based sexual health education
the PLISSIT model includes the steps of PLISSIT (P-Permission), LI-Limited Information, SS-Specific Suggestions, IT-Intensive Therapy. This model provides communication with the patient and Since it is a model that increases confidence and provides care interventions based on the patient's preference, it has the feature of guiding sexual education during pregnancy by establishing the bond between the pregnant woman and the midwife.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Function Level
Time Frame: 12 Mounth
Women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction.
12 Mounth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitude Towards Sexuality During Pregnancy
Time Frame: 12 mounth
An increase in the Attitude Towards Sexuality During Pregnancy score indicates that attitudes towards sexuality during pregnancy are positive.
12 mounth
Sexual Distres Level
Time Frame: 12 mounth
KCDÖ-R consists of 13 items that evaluate different aspects of sexual distress in women and varies between 0-52 points. The scale is a five-point Likert type and is scored between 0-4 points (always=4, often=3, sometimes=2, rarely=1, never=0), and 11.5 and above is defined as sexual distress.
12 mounth

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

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)

May 18, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

July 28, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-74555795-199-990466 17.05.24
  • 17.05.2024-990466 (Other Identifier: ISTANBUL UNIVERSITY)

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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