NCT06530108

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

July 28, 2024

Last Update Submit

July 28, 2024

Conditions

HealthyPregnancy RelatedStress

Keywords

sexual functionsexual attitudesexual distressmidwife careeducation

Outcome Measures

Primary Outcomes (1)

  • Sexual Function Level

    Women with a score ≤ 26.55 as a result of the FSFI evaluation will be defined as having sexual dysfunction.

    12 Mounth

Secondary Outcomes (2)

  • Attitude Towards Sexuality During Pregnancy

    12 mounth

  • Sexual Distres Level

    12 mounth

Study Arms (2)

Experimental: Intervention Group

EXPERIMENTAL

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

Kontrol Group

PLACEBO COMPARATOR

The clinical procedure will be applied to the control group

Behavioral: PLISSIT model based sexual health education

Interventions

PLISSIT model based sexual health educationBEHAVIORAL

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.

Experimental: Intervention GroupKontrol Group

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, 34320, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The data analyse is going to be completed by a independent researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research will be conducted using randomized controlled, experimental type and single-blindresearch methods. For this purpose, after the data are collected, they will be coded as A and Bgroups, so the researcher who will make the research statistics will analyze the data withoutknowing the study and control groups. Randomization method will be used to determine thegroups. For this, the patients who meet the study criteria and volunteer will be assigned to thegroups using the randomization program 'Random Allocation Software 2.0' according to the orderof hospitalization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

May 18, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)