Ondokuz Mayıs University
Samsun, 55200, Turkey (Türkiye)
Location contact
Dilek ÇELİK EREN
CONTACT
Dilek ÇELİK EREN, Dr.
SUB_INVESTIGATOR
Özge Öz Yıldırım, Dr
PRINCIPAL_INVESTIGATOR
İlknur AYDIN AVCİ, Prof. Dr.
SUB_INVESTIGATOR
NCT Number: NCT07126080
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.
Trial opening soon.
Get Notified45 year–55 year
Female
Interventional
Not applicable
Samsun, 55200, Turkey (Türkiye)
Dilek ÇELİK EREN
CONTACT
Dilek ÇELİK EREN, Dr.
SUB_INVESTIGATOR
Özge Öz Yıldırım, Dr
PRINCIPAL_INVESTIGATOR
İlknur AYDIN AVCİ, Prof. Dr.
SUB_INVESTIGATOR
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.
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.
Incontinence Short Test: To determine the level of knowledge about incontinence, Branch et al. The Incontinence Short Test, developed by Kara et al. and whose Turkish version was studied by Kara et al., was used. The 14-item test is answered with "Agree," "Disagree," or "Don't Know." The correct answer for items 1, 4, 6, 8, 10, and 11 is "Agree." For the remaining items, the correct answer is "Disagree." A "Don't Know" response is considered incorrect. The total score ranges from 0 to 14, with a higher score indicating a higher level of knowledge and a more positive attitude toward urinary incontinence.
Intervention: The women in the experimental group will receive a 4-week training program on coping with urinary incontinence. The content of this training consists of the following topics: • Definition, types, and risk factors for urinary incontinence
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention: Women in the experimental group will receive a four-week training program on managing urinary incontinence. The training will cover the following topics:
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Dilek ÇELİK EREN, Dr.
CONTACT
Özge ÖZ YILDIRIM, Dr.
CONTACT
Ondokuz Mayıs University
Other
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
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