CancerNCT05967104
Sexual Education in Women Based On The Plissit Model On Awareness And Attitude in Midwifery Students
A study testing Education based on the PLISSIT model in people with Cancer and Educational Problems, run by Sakarya University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Educational Problems, Sex Behavior
- What is being tested?
- Education based on the PLISSIT model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 27 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a midwifery 3rd year student,
- Agree to participate in the study.
Who cannot join
- -Having failed or not taken the "Gynecology" course even though it is a third year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sexual Education in Women With Gynecological Cancer Based On The Plissit Model On Awareness And Attitude in Midwifery Students: A Randomised Controlled Study
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.
Read the detailed 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.
- Conditions
- Cancer, Educational Problems, Sex Behavior
- Being tested
- Education based on the PLISSIT model
- Keywords
- PLISSIT, sexual education, gynecological cancer, sexual attitudes and beliefs
- Medical subject headings
- Neoplasms, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-intervention, 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 May 2022
- Primary completion20 Jul 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasemin hamlacı başkaya, Sakarya University
- Investigators
- Ahsen DEMİRHAN KAYACIK, Study chair, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967104
- Sponsor's protocol ID
- 03072023
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39161865
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Education in Women With Gynecological Cancer Based On The Plissit Model On Awareness And Attitude in Midwifery Students: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05967104
- Acronym / sponsor ID
- 03072023
- Conditions
- Cancer, Educational Problems, Sex Behavior
- Keywords
- PLISSIT, sexual education, gynecological cancer, sexual attitudes and beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Education based on the PLISSIT modelTraining 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a midwifery 3rd year student,
- Agree to participate in the study.
Key exclusion criteria (1 listed)
- -Having failed or not taken the "Gynecology" course even though it is a third year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education based on the PLISSIT modelTraining 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. | Other | Experimental group |
Primary outcome
Gynecological cancer awareness scale change
Time frame: pre-intervention, 1 month after intervention
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.
Sexual Attitudes and Beliefs Scale Change
Time frame: pre-intervention, 1 month after intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 39161865Demirhan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsen DEMİRHAN KAYACIK study chair
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education based on the PLISSIT model in people with Cancer and Educational Problems, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gynecological cancer awareness scale change (time frame: pre-intervention, 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.