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临床试验/NCT07126080
NCT07126080尚未招募不适用

The Effect of Coping Training on Urinary Incontinence Attitudes, Sleep, and Quality of Life in Postmenopausal Women With Stress Urinary Incontinence: A Randomized Controlled Trial

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
Personal Information Form

研究概览

简要总结

This study aims to examine the effects of urinary incontinence management training provided to postmenopausal women on their urinary incontinence attitudes, sleep, and quality of life.

Hypothesis H1: Following the urinary incontinence management training, there will be an increase in urinary incontinence attitudes, sleep, and quality of life in the women in the experimental group compared to the women in the control group.

详细描述

  1. Research Model: This study will be conducted using a randomized controlled pretest-posttest control group experimental research design.
  2. Research Universe/Sample or Study Group:

This study will be conducted with postmenopausal women over the age of 45 who attended the Gynecology and Obstetrics Clinic of Ondokuz Mayıs University Health Application and Research Center. The study sample size was calculated using the sample size calculator program. Using the Urinary Incontinence Quality of Life Scale as a reference (12.34 (2.18); 5.43 (1.96)) (Başgöl et al., 2025), the sample size was calculated as 36 participants for the experimental group and 36 participants for the control group, with a 5% margin of error, a 90% confidence interval, and an effect size of 33.332. In addition to the minimum sample size, a sample size of 48 participants was determined for each group, with at least 50% spares, for a total of 96 participants. Randomization Simple randomization will be used to unbiasedly assign 96 women who meet the study criteria to the intervention and control groups. Randomization will be determined computer-aided using the Research Randomizer website (https://www.randomizer.org/). Women in the intervention and control groups will be assigned based on the obtained order. 3. Data Collection Tools: A Personal Information Form, the Urinary Incontinence Short Test, the Pittsburgh Sleep Quality Index, and the Urinary Incontinence Quality of Life Scale (I-QOL) will be used to collect data for the study.

Personal Information Form: Consists of a total of 21 questions that ask about the women's sociodemographic characteristics such as age, education level, and income, their characteristics related to childbirth, and their experience of urinary incontinence. Urinary Incontinence Attitude Scale:

Pittsburg Sleep Quality Index: The scale's validity and reliability studies in Turkey were conducted by Ağargün and colleagues in 1996. The PSQI assesses sleep quality over the past month. The PSQI consists of 24 questions, 19 of which are answered by the individual themselves, and 5 by their spouse or roommate. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score greater than 5 is considered the cut-off score indicating poor sleep quality. The scale's Cronbach's alpha reliability coefficient was found to be 0.804.

Urinary Incontinence Quality of Life Scale (I-QOL): The validity and reliability of the I-QOL was performed by Özerdoğan. In the Incontinence Quality of Life Scale, all items are evaluated on a five-item Likert-type scale (1=a lot, 2=quite a bit, 3=moderately, 4=a little, 5=not at all), and the calculated total score is converted to a scale value from 0 to 100 for better understanding. The Incontinence Quality of Life Scale consists of three subscales: restrictive behaviors (items 1, 2, 3, 4, 10, 11, 13, and 20), psychological impact (items 5, 6, 7, 9, 15, 16, 17, 21, and 22), and limitations on social life (items 8, 12, 14, 18, and 19). Higher scores indicate better quality of life than lower scores.

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, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Having entered menopause
  • •Volunteering to participate in the study
  • •Having no communication barriers
  • •Using a smartphone
  • •Having the WhatsApp application
  • •Experiencing urine leakage when coughing or sneezing, as defined by the ICS (International Continence Association)

排除标准

  • •Having a communication barrier
  • •Not having gone through menopause
  • •Not experiencing urinary incontinence
  • •Having undergone surgical menopause
  • •Being obese

研究组 & 干预措施

Intervention Group-Training in Coping with Incontinence

Experimental

Intervention: Women in the experimental group will receive a four-week training program on managing urinary incontinence. The training will cover the following topics:

  • Definition, types, and risk factors of urinary incontinence
  • Treatment and prevention of urinary incontinence
  • Symptoms of urinary incontinence and non-drug management strategies (addressing eating and toilet habits, such as limiting caffeinated beverages and cautioning spicy foods)
  • The importance and implementation of Kegel exercises After the training, the experimental group will be reminded to practice Kegel exercises, and post-tests will be administered at 1 and 3 months. The control group will also receive post-tests at 1 and 3 months. Training will be conducted individually online.

干预措施: Incontinence Coping Training (Behavioral)

Control Group

No Intervention

No ıntervention.

结局指标

主要结局

Personal Information Form

时间窗: 16 weeks

It consists of a total of 21 questions asking about women's sociodemographic characteristics such as age, education level, income level, birth-related characteristics and urinary incontinence.

The incontinence short test:

时间窗: 16 weeks

A Turkish validity and reliability study was conducted by Kara et al. The test consists of 14 statements and is answered with "Agree," "Disagree," or "Don't Know." The correct answer for statements 1, 4, 6, 8, 10, and 11 is "Agree." The correct answer for the remaining statements is "Disagree." A "Don't Know" response is considered incorrect. The total score ranges from 0 to 14, with higher scores indicating a higher level of knowledge and a more positive attitude toward urinary incontinence.

Urinary Incontinence Quality of Life Scale (I-QOL):

时间窗: 16 weeks

The validity and reliability of the I-QOL was determined by Özerdoğan. All items in the Incontinence Quality of Life Scale are evaluated on a five-category Likert-type scale (1=a great deal, 2=quite a bit, 3=moderately, 4=a little, 5=not at all), and the calculated total score is converted to a scale value from 0 to 100 for better understanding. The Incontinence Quality of Life Scale consists of three subscales: behavioral limitation (items 1, 2, 3, 4, 10, 11, 13, and 20), psychological impact (items 5, 6, 7, 9, 15, 16, 17, 21, and 22), and social limitation (items 8, 12, 14, 18, and 19). High scores indicate better quality of life than low scores.

Pittsburgh Sleep Quality Index:

时间窗: 16 weeks

The scale's validity and reliability studies in Turkey were conducted by Ağargün and colleagues in 1996. The PSQI assesses sleep quality over the past month. The PSQI consists of 24 questions, 19 of which are answered by the individual themselves, and 5 by their spouse or roommate. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. A total PSQI score of 5 or higher is considered the cut-off score for poor sleep quality. The scale's Cronbach's alpha reliability coefficient was found to be 0.804.

Personal Information Form

时间窗: 4 weeks

It consists of a total of 21 questions asking about women's sociodemographic characteristics such as age, education level, income level, birth-related characteristics and urinary incontinence.

次要结局

未报告次要终点

研究者

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

Dilek Celi̇k Eren

Ass. Prof.

Ondokuz Mayıs University

研究点 (1)

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