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临床试验/NCT07538752
NCT07538752已完成不适用

The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence: A Randomized Controlled Trial

Al-Quds University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Psychological distress

研究概览

简要总结

This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.

详细描述

Background: Urinary incontinence is a common problem experienced by postmenopausal women, which greatly impacts their psychological state and quality of life. Although urinary incontinence is a common problem, it is often underreported.

Aim: This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.

Design: A Randomized Controlled Trial with pre-test and post-test assessments in both intervention and control groups was conducted.

Setting: The present research was conducted in Egypt, Gharbia Governorate, Tanta city, at gynecological outpatient clinics of Tanta University Hospital and El-Menshawy Hospital.

Tools: A structured interviewing questionnaire, Kessler Psychological Distress Scale, Incontinence Impact Questionnaire (IIQ-7), and incontinence severity index.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Women diagnosed with urinary incontinence during the postmenopausal phase
  • Women having the ability to read and write.

排除标准

  • Women with diabetic nephropathy.
  • Women with previous central nervous system injuries.
  • Women with bladder cancer.
  • Women with urinary tract infections,
  • Women with other significant neurological disorders.

研究组 & 干预措施

intervention group, which received the continuous care model.

Experimental

The study examined the effects of the intervention ( continuous care model) on the psychological distress and quality of life of postmenopausal women who experienced urinary incontinence.

干预措施: Continuous Care Model sessions (Behavioral)

Control group (no intervention)

No Intervention

The control group was provided with standard care at the outpatient clinics but did not receive the Continuous Care Model sessions. They were assessed at the same time as the intervention group.

结局指标

主要结局

Psychological distress

时间窗: 6 months

Psychological distress was measured using the Kessler Psychological Distress Scale (K10), a frequently used self-report tool for assessing symptoms of anxiety and depression. The K10 scale consists of 10 items, with each item rated on a 5-point Likert scale ranging from "none of the time" (1) to "all of the time" (5), yielding a total score between 10 and 50, indicating that higher scores signify greater psychological distress. The results are commonly interpreted using categorized thresholds: scores between 10 and 19 indicate a low likelihood of psychological distress, 20-24 suggest mild distress, 25-29 indicate moderate distress, and scores between 30 and 50 reflect severe psychological distress.

Women' quality of life.

时间窗: 6 months

The IIQ-7 was adopted from Uebersax et al., (1995) and specifically designed to evaluate the influence of UI on women' quality of life.

次要结局

未报告次要终点

研究者

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

Ashraf Jehad Abuejheisheh

Dr.

Al-Quds University

研究点 (1)

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