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临床试验/NCT05373550
NCT05373550Unknown不适用

Effectiveness of a Nursing Educational Intervention on Quality of Life, Sexual Function, and Self-esteem in Hysterectomized Women: a Mixed-method Approach

Universidad de Concepcion2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年9月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Female sexual function

研究概览

简要总结

Surgical hysterectomy is second only to cesarean section as a surgical procedure in women, causing an impact on sexual function, quality of life, and self-esteem, therefore it is necessary to incorporate a comprehensive care in search of women's welfare.

Objectives: To know the meaning of education in the perioperative period, in women submitted to hysterectomy for a benign cause.

To determine the efficacy of a nursing educational intervention based on self-care in the improvement of sexual function, health-related quality of life, and self-esteem in women undergoing hysterectomy for benign causes.

Subjects and methods: A sequential exploratory mixed-method study. For the qualitative phase, individual interviews will be conducted with women (35 to 65 years old) with the indication of hysterectomy for benign pathology attending the gynecology office, who will be contacted and invited to participate. The interviews will be analyzed using the content analysis technique. The quantitative phase will correspond to a quasi-experimental study design with a non-equivalent control group in women with indications for hysterectomy between 35 and 65 years old in two Obstetric Gynecological Hospitals in Quito. At least 26 women on the waiting list for hysterectomy for the experimental group and 26 for the comparison group will be included.

Instruments: Bio-sociodemographic questionnaire, Female Sexual Function Index, SF-36, and Rosenberg Scale. The two groups will receive traditional care and the experimental group will additionally receive face-to-face nursing educational intervention with technological support.

Ethical requirements will be considered. Expected results: After the nursing education intervention with technological support, women in the experimental group will improve their sexual function, health-related quality of life, and self-esteem concerning the comparison group

详细描述

TITLE: Effectiveness of a nursing educational intervention on quality of life, sexual function and self-esteem in hysterectomized women: a mixed-method approach.

1.1 PRESENTATION AND RATIONALE OF THE PROBLEM The 20th century has been decisive for the development in different areas of medicine, the great advances achieved have allowed to increase life expectancy at birth and to modify the population pyramids in many countries of the world, reaching in Ecuador 79.30 years in women and 73.33 in men, which has determined that more and more women spend at least a third of their lives after menopause.

However, it is worth mentioning that the physiological transition of menopause can be altered by a surgical procedure to resolve common and more prevalent benign neoplasms such as fibroids, abnormal uterine bleeding, pelvic pressure, among others, inducing surgical or induced menopause in some cases, defined by the Council of Affiliated Menopause Societies (CAMS), of the International Menopause Society, as the definitive cessation of menstruation due to irreversible gonadal damage induced by surgical excision.

Hysterectomy is the most performed major gynecological procedure in the world, becoming a subject of controversy from its beginnings to the present time, therefore, hysterectomy is the last decision in the treatment of gynecological problems and leads the woman to a long period of symptoms for the final decision.

Although most hysterectomies are performed to improve the woman's quality of life, their impact has not been adequately measured and can be markedly heterogeneous, with reports of beneficial, negative, and neutral effects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

As blinding is a necessary condition in this type of study, the knowledge of the surveyors in the collection of the data, about the experimental group and comparison group will be safeguarded, for which the list of the participating women will be delivered in sealed envelopes and they will only know as group A and group B, both at the beginning and at the end of the study in the pre-test and post-test, with the aim of preventing certain biases in some of the stages of the study, reducing the possibility that the variables of results and their measurement are influenced by lack of blinding.

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria Be a woman between 35 and 65 years old, with a partner, on the waiting list for surgery scheduling (two weeks prior to surgery date assignment), with benign pathology, who knows how to read and write and has internet access.

排除标准

  • Women with oncological pathology, complications or obstetric indication, with ectopic pregnancy, with oophorectomy, with mental illness or dementia, with a combination of several surgical procedures or some degree of physical or cognitive disability.

结局指标

主要结局

Female sexual function

时间窗: 12 weeks and corresponds to the perioperative period for hysterectomy.

The primary outcome expected from the intervention is the following to change Female Sexual Function in the hysterectomized woman. It will be measured with the Female Sexual Function Index, to achieve a score greater than 26 in the total sum of all domains, since a score less than 26 means sexual dysfunction.

次要结局

  • Health-related quality of life(12 weeks and corresponds to the perioperative period for hysterectomy.)
  • Self-Steem(12 weeks and corresponds to the perioperative period for hysterectomy.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alide Salazar Molina

Research director

Universidad de Concepcion

研究点 (2)

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