HysterectomyNCT06609096
The Effect of Sexual Counselling Based on PLISSIT and BETTER Model After Hysterectomy
A study testing Sexual counseling based on the PLISSIT model and Sexual counseling based on the BETTER model in people with Hysterectomy and PLISSIT Model, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
Sexuality is affected by several physiological, cultural, social, and psychological factors. Hysterectomy is one of the factors that affects sexuality. Evidence suggests that hysterectomy, affects the sexual function of women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy, PLISSIT Model, Sexual Health Quality of Life
- What is being tested?
- Sexual counseling based on the PLISSIT model and Sexual counseling based on the BETTER model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 Jul 2024to 1 Mar 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having a sexual partner
- Sexual intercourse within the last month,
- A score below 26.55 on the Female Sexual Function Scale,
- At least 3 months after the hysterectomy operation,
- No previous radiotherapy or chemotherapy treatment,
- Not having any communication problems (mental, auditory, visual, etc.),
Show all 11Show fewer
- Not being involved in any other sexuality-related treatment program,
- Becoming literate,
- Having a smartphone,
- Access to the Internet
- Volunteering to participate in the study
Who cannot join
- Different treatment protocols due to malignancy (radiotherapy and chemotherapy or additional surgical treatment of the reproductive organs)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University Health Research And Application Center
Ankara, 06500
Kütahya Health Sciences University
Kütahya, 43020
About this study
Official title: The Effect of Sexual Counselling Based on PLISSIT and BETTER Model on Sexual Function and Quality of Sexual Life After Hysterectomy: A Randomised Controlled Trial
Sexuality is affected by several physiological, cultural, social, and psychological factors. Hysterectomy is one of the factors that affects sexuality. Evidence suggests that hysterectomy, affects the sexual function of women. Therefore, this study aimed to evaluate the effect of sexual counseling based on the PLISSIT and BETTER models on sexual function and quality of sexual life of women after hysterectomy. This study is a randomized controlled trial with a three-arm parallel design. One of the experimental groups will receive sexual counseling based on the PLISSIT model and the other will receive sexual counseling based on the BETTER model. The control group will not receive any intervention. The difference between the intervention groups and the control group will be evaluated.
Read the detailed description
Nurses are integral members of the health care team in providing care and counseling for sexual health. The provision of education and counseling services to enhance sexual health and research on the subject play significant roles for nurses. In this context, nurses should facilitate up-to-date information dissemination to clients by investigating sexual counseling models. Furthermore, nurses have crucial duties and responsibilities for maintaining evidence-based care practices that utilize these models. Addressing sexual life and adopting a holistic approach to nursing care services are essential considerations. The utilization of models is recommended to assist nurses in evaluating sexuality of patients, which is a sensitive subject, in an appropriate manner and to provide them with the most suitable care in this regard. One such model was the PLISSIT Model. The PLISSIT Model was employed to assess and improve sexual health in patients with breast cancer, multiple sclerosis, gynecologic cancer, type 2 diabetes mellitus, HIV-positive status, and stoma. Additionally, it is actively used in different life stages of women such as pregnancy and postpartum period. In the literature, the results of studies in which sexual counseling based on the PLISSIT model was applied to women undergoing hysterectomy indicate that the model has positive effects on sexual function and quality of sexual life. However, the PLISSIT model has limitations, such as the requirement for skills at the fourth stage of sexual rehabilitation at the 4th stage and its linearity (progressing from one level to another). One of the alternative approaches in sexual counseling is the BETTER Model due to its specific emphasis on developing dialogues on sexual health and the importance of sexual issues. This model has been utilized in the literature to provide sexual counseling to women with multiple sclerosis, women with breast cancer, infertile women, and postpartum women. However, no study was identified in the literature in which sexual counseling based on the BETTER model was provided to women with hysterectomy. Evidence of the effectiveness of model-based sexual counseling in women with sexual dysfunction after hysterectomy is insufficient.
- Conditions
- Hysterectomy, PLISSIT Model, Sexual Health Quality of Life, Sexual Function, Sexual Health
- Being tested
- Sexual counseling based on the PLISSIT model, Sexual counseling based on the BETTER model
- Keywords
- sexual health, Hysterectomy, Sexual Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual counseling based on the PLISSIT modelBehavioural
Four sessions of sexual counseling based on the PLISSIT model will be provided. The intervention consisted of four consecutive sessions, with one session per week. Each session is 30 minutes on average.
Sexual counseling based on the BETTER modelBehavioural
A total of four sessions of sexual counseling based on the BETTER model will be provided. The intervention consists of four consecutive sessions, one session per week. Each session is 30 minutes on average.
| Study group | Role | What they receive |
|---|---|---|
| PLISSIT Group | Experimental | Women assigned to the sexual counseling group based on the PLISSIT model will receive four sessions in total, once a week. Each session consisted of an average of 30 min. Sessions will be conducted online as individual counselling sessions. The Plissit model was used based on a four-stage approach. These stages are (P-Permission): Permission, (Ll- Limited Information), providing limited information (SS-Specific Suggestions): Giving specific suggestions, (IT- Intensive Therapy): Intensive Therapy. In this study, the first three stages of the model will be applied. After the first three stages of the model are implemented, women with ongoing sexual problems are referred to specialized sexual therapists for intensive treatment/therapy. Receives: Behavioral: Sexual counseling based on the PLISSIT model |
| BETTER Group | Experimental | Women assigned to the sexual counseling group based on the BETTER model will receive four sessions in total, once a week. Each session will consist of 30 minutes on average. Better model consists of Bring up the topic, Explain, Telling, Timing, Education and Recording steps. The sessions will be conducted online as individual counselling sessions. Receives: Behavioral: Sexual counseling based on the BETTER model |
| Control Group | No intervention | Women in the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Quality of Life Scale-Female Scale
Sexual Quality of Life Scale-Female (SQOL-F) developed by Symonds et al. (2005). The scale should be completed by considering sexual life in the last four weeks. The scale consisted of 18 items and was evaluated between 1 and 6 points. As the scale score increased, so did the quality of sexual life.
Measured: Change from baseline level sexual function to month 1 and month 2
Female Sexual Function Scale
The Female Sexual Function Scale (FSFI) developed by Rosen et al. (2000) focused on sexual problems in the last four weeks and evaluated sexual function. It consists of 19 questions and six sub-dimensions including desire, arousal, lubrication, orgasm, satisfaction, and pain. The scores obtained from the scale varied between 2 and 36. As the scale score increased, sexual function also increased. The cutoff score of the scale was 26.55. Those with a score of 26.55 and below were considered to have female sexual dysfunction.
Measured: Change from baseline level sexual function to month 1 and month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start23 Jul 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Sevil Cicek Ozdemir, Kutahya Health Sciences University
- Investigators
- Sevil Çiçek Özdemir, Asst. Prof., Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609096
- Sponsor's protocol ID
- 908520
- Status last verified
- Aug 2025
- First submitted
- 20 Sep 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counselling Based on PLISSIT and BETTER Model on Sexual Function and Quality of Sexual Life After Hysterectomy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06609096
- Acronym / sponsor ID
- 908520
- Conditions
- Hysterectomy, PLISSIT Model, Sexual Health Quality of Life, Sexual Function, Sexual Health
- Keywords
- sexual health, Hysterectomy, Sexual Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 24 Sep 2024 (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.
Sexuality is affected by several physiological, cultural, social, and psychological factors. Hysterectomy is one of the factors that affects sexuality. Evidence suggests that hysterectomy, affects the sexual function of women. Therefore, this study aimed to evaluate the effect of sexual counseling based on the PLISSIT and BETTER models on sexual function and quality of sexual life of women after hysterectomy. This study is a randomized controlled trial with a three-arm parallel design. One of the experimental groups will receive sexual counseling based on the PLISSIT model and the other will receive sexual counseling based on the BETTER model. The control group will not receive any intervention. The difference between the intervention groups and the control group will be evaluated.
Detailed description
Nurses are integral members of the health care team in providing care and counseling for sexual health. The provision of education and counseling services to enhance sexual health and research on the subject play significant roles for nurses. In this context, nurses should facilitate up-to-date information dissemination to clients by investigating sexual counseling models. Furthermore, nurses have crucial duties and responsibilities for maintaining evidence-based care practices that utilize these models. Addressing sexual life and adopting a holistic approach to nursing care services are essential considerations. The utilization of models is recommended to assist nurses in evaluating sexuality of patients, which is a sensitive subject, in an appropriate manner and to provide them with the most suitable care in this regard. One such model was the PLISSIT Model. The PLISSIT Model was employed to assess and improve sexual health in patients with breast cancer, multiple sclerosis, gynecologic cancer, type 2 diabetes mellitus, HIV-positive status, and stoma. Additionally, it is actively used in different life stages of women such as pregnancy and postpartum period. In the literature, the results of studies in which sexual counseling based on the PLISSIT model was applied to women undergoing hysterectomy indicate that the model has positive effects on sexual function and quality of sexual life. However, the PLISSIT model has limitations, such as the requirement for skills at the fourth stage of sexual rehabilitation at the 4th stage and its linearity (progressing from one level to another). One of the alternative approaches in sexual counseling is the BETTER Model due to its specific emphasis on developing dialogues on sexual health and the importance of sexual issues. This model has been utilized in the literature to provide sexual counseling to women with multiple sclerosis, women with breast cancer, infertile women, and postpartum women. However, no study was identified in the literature in which sexual counseling based on the BETTER model was provided to women with hysterectomy. Evidence of the effectiveness of model-based sexual counseling in women with sexual dysfunction after hysterectomy is insufficient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLISSIT Group | Experimental | Behavioral: Sexual counseling based on the PLISSIT modelWomen assigned to the sexual counseling group based on the PLISSIT model will receive four sessions in total, once a week. Each session consisted of an average of 30 min. Sessions will be conducted online as individual counselling sessions. The Plissit model was used based on a four-stage approach. These stages are (P-Permission): Permission, (Ll- Limited Information), providing limited information (SS-Specific Suggestions): Giving specific suggestions, (IT- Intensive Therapy): Intensive Therapy. In this study, the first three stages of the model will be applied. After the first three stages of the model are implemented, women with ongoing sexual problems are referred to specialized sexual therapists for intensive treatment/therapy. |
| BETTER Group | Experimental | Behavioral: Sexual counseling based on the BETTER modelWomen assigned to the sexual counseling group based on the BETTER model will receive four sessions in total, once a week. Each session will consist of 30 minutes on average. Better model consists of Bring up the topic, Explain, Telling, Timing, Education and Recording steps. The sessions will be conducted online as individual counselling sessions. |
| Control Group | No intervention | –Women in the control group will not receive any intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Having a sexual partner
- Sexual intercourse within the last month,
- A score below 26.55 on the Female Sexual Function Scale,
- At least 3 months after the hysterectomy operation,
- No previous radiotherapy or chemotherapy treatment,
Key exclusion criteria (1 listed)
- Different treatment protocols due to malignancy (radiotherapy and chemotherapy or additional surgical treatment of the reproductive organs)
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 |
|---|---|---|
| Sexual counseling based on the PLISSIT modelFour sessions of sexual counseling based on the PLISSIT model will be provided. The intervention consisted of four consecutive sessions, with one session per week. Each session is 30 minutes on average. | Behavioural | PLISSIT Group |
| Sexual counseling based on the BETTER modelA total of four sessions of sexual counseling based on the BETTER model will be provided. The intervention consists of four consecutive sessions, one session per week. Each session is 30 minutes on average. | Behavioural | BETTER Group |
Primary outcome
Sexual Quality of Life Scale-Female Scale
Time frame: Change from baseline level sexual function to month 1 and month 2
Sexual Quality of Life Scale-Female (SQOL-F) developed by Symonds et al. (2005). The scale should be completed by considering sexual life in the last four weeks. The scale consisted of 18 items and was evaluated between 1 and 6 points. As the scale score increased, so did the quality of sexual life.
Female Sexual Function Scale
Time frame: Change from baseline level sexual function to month 1 and month 2
The Female Sexual Function Scale (FSFI) developed by Rosen et al. (2000) focused on sexual problems in the last four weeks and evaluated sexual function. It consists of 19 questions and six sub-dimensions including desire, arousal, lubrication, orgasm, satisfaction, and pain. The scores obtained from the scale varied between 2 and 36. As the scale score increased, sexual function also increased. The cutoff score of the scale was 26.55. Those with a score of 26.55 and below were considered to have female sexual dysfunction.
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 3 Sep 2025.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data available to other researchers.
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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.
Sevil Çiçek Özdemir, Asst. Prof. principal investigator
Kütahya Health Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual counseling based on the PLISSIT model and Sexual counseling based on the BETTER model in people with Hysterectomy and PLISSIT Model, run by Kutahya Health Sciences University at 2 sites 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 11 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sexual Quality of Life Scale-Female Scale (time frame: Change from baseline level sexual function to month 1 and month 2). 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?
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 3 Sep 2025.