Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05967104
Other study ID # 03072023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date February 27, 2023

Study information

Verified date July 2023
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (CTÄ°Ö) before the training and after the completion of the 3 trainings.


Description:

Intervention In order to improve the educational content, researchers conducted a literature review on gynecological cancers, sexual problems in gynecological cancer, sexual counseling. The training content was created after the literature review. Gynecological cancers are malignant diseases of the ovaries, cervix, endometrium, vulva, vagina and fallopian tubes that make up the female reproductive system. GLOBACAN (Global Cancer Observatory) 2020 data show that gynecological cancers rank fourth among the most common types of cancer among women in the world. Gynecological cancers are responsible for more than 100,000 incidences and 32,000 deaths per year. Significant changes are taking place, especially in the area of sexuality. It is known that sexually active gynecological cancer cases often complain of dyspareunia, vaginal dryness, postcoital bleeding, deterioration in sexual arousal, lack of sexual desire, genitopelvic pain. In addition, changes in the female genital organs, such as vaginal stenosis, vaginal dryness, scar formation in the vagina and vaginal atrophy, can lead to sexual dysfunction. Sexual dysfunction is one of the most common and troubling qualities of life issues faced by women with gynecological cancer, but it is rarely discussed among cancer patients, survivors, and health professionals. Therefore, a comprehensive assessment of sexual health from the first visit of patients should be carried out as a routine part of each examination. In this regard, health professionals need to apply resources that will encourage effective, sensitive, communication with patients about sexual health problems. One of the most widely used interventions in the field of assessing and managing sexual problems is the PLISSIT model. The PLISSIT model provides a safe, tolerant and therapeutic environment for the discussion of sexual concerns, encouraging referral to an appropriate specialist as needed. The model consists of four steps to address sexual concerns: Consent, Limited Information, Specific Recommendations, and Intensive Therapy. The first stage of this model is to allow patients to share their thoughts and concerns about their sex life. In the second stage, individuals are informed about their thoughts and concerns about their sex life. In the third stage, patients are given "special recommendations". Specific recommendations should be appropriate to each person's individual needs. At this point, health professionals need to know more about sexuality in order to give patient-specific information. The fourth stage involves the referral of the patient to the relevant specialist. This model enables healthcare professionals to develop effective strategies for addressing sexual concerns. In order for the model to be applied effectively, it is essential that the relevant health professionals are informed about the subject. In this context, it is very important to show health professionals and students studying in the field of health that sexuality is very important in women with gynecological cancer, to raise their awareness in the field and to ensure that their positive attitudes towards sexuality are formed. For this reason, in this study, 3rd-year students of the midwifery department were trained on "sexuality education for women with gynecological cancer" prepared based on the PLISSIT model, and it was examined how the gynecological cancer awareness and sexual attitudes and beliefs of the students were affected. In this study, it is aimed to determine the effect of sexuality education in line with the PLISSIT model on the gynecological cancer awareness levels of the students and their sexual attitudes and beliefs.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date February 27, 2023
Est. primary completion date July 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being a midwifery 3rd year student, - Agree to participate in the study. Exclusion Criteria: -Having failed or not taken the "Gynecology" course even though it is a third year.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education based on the PLISSIT model
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.

Locations

Country Name City State
Turkey Sakarya University Sakarya

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases