NCT05967104

Brief Summary

In this study, it was aimed to determine the awareness levels and attitudes of the students with the sexual counseling training conducted in line with the PLISSIT model. This experimental (randomized-controlled) study was conducted with midwifery students who agreed to participate in the study and met the inclusion criteria at a state university in western Turkey. As a result of the randomization, there were 38 students in the intervention group and 36 students in the control group. While training based on the PLISSIT framework was given to the intervention group, no training was given to the control group. Data were collected through the Introductory Information Form, the Gynecological Cancer Awareness Scale (GCPS), and the Sexual Attitudes and Beliefs Scale (CTİÖ) before the training and after the completion of the 3 trainings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 13, 2023

Last Update Submit

July 21, 2023

Conditions

CancerEducational ProblemsSex Behavior

Keywords

PLISSITsexual educationgynecological cancersexual attitudes and beliefs

Outcome Measures

Primary Outcomes (2)

  • Gynecological cancer awareness scale change

    Scale; It consists of four sub-dimensions: routine control and awareness of serious disease perception in gynecological cancers, awareness of gynecological cancer risks, awareness of prevention from gynecological cancers and early diagnosis and information awareness in gynecological cancers.

    pre-intervention, 1 month after intervention

  • Sexual Attitudes and Beliefs Scale Change

    high scores from scale items and grand total; It shows that negative beliefs and attitudes towards evaluating the patient's sexuality/providing sexual counseling increase and there are more obstacles in evaluating sexual problems and providing counseling.

    pre-intervention, 1 month after intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework. Questionnaires (Introductory individual form, Gynecological cancer awareness scale and Sexual Attitudes and Beliefs Scale) were completed by students included in the intervention and control groups at the beginning and one month after the completion of the 3 training sessions.

Other: Education based on the PLISSIT model

Control group

NO INTERVENTION

The students in the control group were not given any training within the scope of the study, and they only had knowledge about gynecological cancers and sexuality, which are included in the course content of gynecological diseases. However, in order to comply with ethical principles, training information was provided online to the control group after the study data collection process was completed.

Interventions

Education based on the PLISSIT modelOTHER

Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.

Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a midwifery 3rd year student,
  • Agree to participate in the study.

You may not qualify if:

  • Having failed or not taken the "Gynecology" course even though it is a third year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Turkey (Türkiye)

Location

Related Publications (1)

  • Demirhan Kayacik A, Hamlaci Baskaya Y, Ilcioglu K. Effect of Sexual Counseling Training in Gynecological Cancers According to the PLISSIT Model on Midwifery Students' Awareness and Attitude: A Randomized Clinical Trial. Int J Community Based Nurs Midwifery. 2024 Jul 1;12(3):140-149. doi: 10.30476/IJCBNM.2024.100377.2355. eCollection 2024 Jul.

    PMID: 39161865DERIVED

MeSH Terms

Conditions

NeoplasmsSexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ahsen DEMİRHAN KAYACIK

    Sakarya University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Midwifery Depatment

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 1, 2023

Study Start

May 1, 2022

Primary Completion

July 20, 2022

Study Completion

February 27, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)