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临床试验/NCT07721727
NCT07721727尚未招募不适用

Evaluation of the Effects of a Hysterectomy Adherence Education Program Based on the Roy Adaptation Model on Hysterectomy Adherence, Self-Esteem, and Quality of Life in Women Undergoing Hysterectomy

Ufuk University0 个研究点目标入组 108 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
主要终点
Hysterectomy Adaptation

研究概览

简要总结

**Brief Summary**

This randomized controlled trial aims to evaluate the effectiveness of a Roy Adaptation Model-based hysterectomy adaptation education program on adaptation to hysterectomy, self-esteem, and quality of life in women who have undergone hysterectomy. A total of 110 participants will be randomly assigned to either the intervention group (n = 55) or the control group (n = 55). The intervention group will receive the Roy Adaptation Model-based education program, while the control group will receive routine care. Outcomes will be assessed using the Hysterectomy Adaptation Scale, Rosenberg Self-Esteem Rating Scale, and WHOQOL-BREF. The study will determine whether the education program improves adaptation, self-esteem, and quality of life compared with routine care.

详细描述

This research is planned as a randomized controlled trial to evaluate the effect of a hysterectomy adaptation training program, based on the Roy Adaptation Model, on hysterectomy compliance, self-esteem, and quality of life in women who have undergone hysterectomy. The study aims to assess the effectiveness of the hysterectomy adaptation training program developed based on the Roy Adaptation Model. A G-Power analysis was conducted to determine the sample size. The sample will consist of 110 individuals: 55 in the control group and 55 in the intervention group. The data collection tools used in the research are: "Personal Information Form (PIF), Hysterectomy Adaptation Scale, Rosenberg Self-Esteem Rating Scale (RSR), and World Health Organization Quality of Life Scale (WHOQOL-BREF). Participants will be assigned to the intervention and control groups using a simple randomization method. The intervention group will receive the hysterectomy adaptation training program developed based on the Roy Adaptation Model. The control group will undergo routine follow-ups.

研究设计

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

盲法说明

Masking was not feasible because participants and the researcher delivering the Roy Adaptation Model-based education program were aware of the group assignments. Therefore, this study was conducted as an open-label randomized controlled trial.

入排标准

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

入选标准

  • Women who have completed at least primary school education. Premenopausal women who have undergone hysterectomy. Have access to the internet and possess a device (smartphone, tablet, or computer) capable of participating in online education sessions.
  • Have an adequate level of health literacy to understand the educational materials, access online information, and follow the intervention.
  • Be sexually active.

排除标准

  • Diagnosed with a sleep disorder. Have a physical and/or mental disability. Have communication difficulties (e.g., speech, language, comprehension, or cognitive impairment).
  • Have a diagnosis of cancer. Currently receiving hormone therapy.

结局指标

主要结局

Hysterectomy Adaptation

时间窗: 8 weeks after training

Adaptation to hysterectomy will be assessed using the Hysterectomy Adaptation Scale. Higher scores indicate better adaptation to life after hysterectomy. Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between the intervention and control groups.

Hysterectomy Adaptation

时间窗: Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between

Adaptation to hysterectomy will be assessed using the Hysterectomy Adaptation Scale. Higher scores indicate better adaptation to life after hysterectomy.

次要结局

未报告次要终点

研究者

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

Gizem Bilmez

PhD Student

Ankara Yildirim Beyazıt University

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