- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06609096
The Effect of Sexual Counselling Based on PLISSIT and BETTER Model After Hysterectomy
August 31, 2025 updated by: Sevil Cicek Ozdemir, Kutahya Health Sciences University
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.
Study Overview
Status
Completed
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey (Türkiye), 06500
- Gazi University Health Research And Application Center
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Kütahya, Turkey (Türkiye), 43020
- Kutahya Health Sciences University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.),
- 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
Exclusion Criteria:
- Different treatment protocols due to malignancy (radiotherapy and chemotherapy or additional surgical treatment of the reproductive organs)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PLISSIT Group
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.
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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.
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Experimental: BETTER Group
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.
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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.
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No Intervention: Control Group
Women in the control group will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Quality of Life Scale-Female Scale
Time Frame: Change from baseline level sexual function to month 1 and month 2
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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.
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Change from baseline level sexual function to month 1 and month 2
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Female Sexual Function Scale
Time Frame: Change from baseline level sexual function to month 1 and month 2
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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.
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Change from baseline level sexual function to month 1 and month 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sevil Çiçek Özdemir, Asst. Prof., Kutahya Health Sciences University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2024
Primary Completion (Actual)
January 1, 2025
Study Completion (Actual)
March 1, 2025
Study Registration Dates
First Submitted
September 20, 2024
First Submitted That Met QC Criteria
September 20, 2024
First Posted (Actual)
September 24, 2024
Study Record Updates
Last Update Posted (Estimated)
September 3, 2025
Last Update Submitted That Met QC Criteria
August 31, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 908520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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