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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06500
        • Gazi University Health Research And Application Center
      • Kütahya, Turkey (Türkiye), 43020
        • Kutahya Health Sciences University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Sexual counseling based on the PLISSIT model
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.
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.
Behavioral: Sexual counseling based on the BETTER model
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.
No Intervention: Control Group
Women in the control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
Change from baseline level sexual function to month 1 and month 2
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.
Change from baseline level sexual function to month 1 and month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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