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临床试验/NCT06609096
NCT06609096已完成不适用

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

Kutahya Health Sciences University4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
4
主要终点
Sexual Quality of Life Scale-Female Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

In order to prevent outcome reporting bias, the data obtained from the study will be coded as A, B and C by an independent researcher and transferred to the SPSS program. Group assignment will be concealed from the researchers during the data analysis and reporting process.

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Different treatment protocols due to malignancy (radiotherapy and chemotherapy or additional surgical treatment of the reproductive organs)

结局指标

主要结局

Sexual Quality of Life Scale-Female Scale

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevil Cicek Ozdemir

Assistant professor

Kutahya Health Sciences University

研究点 (4)

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