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

NCT06862011 | Active Not Recruiting

• 1 other identifier: GaziosmanpasaU-OS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; PLISSIT Model; Primiparity

Keywords

pregnancy; primiparous; PLISSIT; Sexual counseling

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Scale

  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 Outcomes (1)

• Sexual Self-Efficacy Scale

  5 weeks

Other Outcomes (2)

• Attitude Towards Sexuality During Pregnancy Scale (

  5 weeks

• Sexual Life Quality Scale-Female Version

  5 weeks

Study Arms (2)

Intervention group (pregnant women receiving sexual counselling)

EXPERIMENTAL

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

Control Group (pregnant women not receiving sexual counselling)

NO INTERVENTION

Scales and forms for the control group will be completed at the end of the second and fourth weeks.

Interventions

control group BEHAVIORAL

Only surveys will be filled out.

Intervention group (pregnant women receiving sexual counselling)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• Ankara Yildirim Beyazıt University: collaborator

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The data from the study will be examined by an independent statistician. The person doing the analysis will not know the groups. Pregnant women included in the study will later learn which group they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tokat Gaziosmanpasa University

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 6, 2025
• Study Start: March 15, 2025
• Primary Completion: May 15, 2025
• Study Completion: June 30, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)