Clinical trial NCT06609096: The Effect of Sexual Counselling Based on PLISSIT and BETTER Model After Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hysterectomy
PLISSIT Model
Sexual Health Quality of Life
Sexual Function
Sexual Health
Keywords: sexual health
Hysterectomy
Sexual Counseling
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-09-24
Enrollment: 54
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sexual Quality of Life Scale-Female Scale
timeFrame: Change from baseline level sexual function to month 1 and month 2
measure: Female Sexual Function Scale
timeFrame: Change from baseline level sexual function to month 1 and month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Health Research And Application Center
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University
Study officials:
affiliation: Kütahya Health Sciences University
name: Sevil Çiçek Özdemir, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: