Clinical trial NCT05589194: Comfort Theory-Based Nursing Interventions in Women with Stress Urinary Incontinence
Official title: The Effect of Comfort Theory-Based Nursing Interventions on Urinary Incontinence, Quality of Life, and Comfort Levels in Women with Stress Urinary Incontinence: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Comfort Theory
Yoga
Nursing
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a randomized controlled single-blind quasi-experimental research design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Urinary incontinence (UI) is a symptom that develops due to damage to the bladder, sphincter mechanism or pelvic floor muscles, defined as unconscious urinary incontinence, which is a common health problem among adult women. Urinary incontinence can be classified as urge incontinence (UUI), stress incontinence (SUI) or mixed incontinence (MUI). Considering the prevalence values of UI subtypes that change with age, it was found that SUI was the highest (32%) in the 40-59 age group.

Although UI is not life-threatening, it imposes significant limitations on women's activities of daily living and sexual and interpersonal relationships. Emotional problems such as embarrassment, depression, sadness and low body image associated with UI have a negative impact on quality of life. Pharmacological, surgical and behavioral treatment methods can be applied in the treatment of UI, which causes significant negative effects on quality of life. However, there are various limitations in the implementation of these methods. This situation has revealed the necessity of developing new methods in the treatment of UI. One of the behavioral treatment methods that can provide therapeutic benefits for urinary incontinence is yoga. Recently, yoga has become a new option for strengthening pelvic floor muscles and treating symptoms related to pelvic floor dysfunctions. Yoga can be practiced by women without constant supervision by healthcare providers, thus providing an accessible and cost-effective self-management strategy for large numbers of women in the community.

Nurses have important roles and responsibilities in the diagnosis, treatment and care process of UI. Nurses need to plan and implement a care that will increase the quality of life and provide comfort for patients with UI. The word comfort, which we often use in our daily life, expresses a basic human need. The taxonomic structure of the Comfort Theory, which was formed on the basis of the concept of comfort, which is a nursing function, attempt and at the same time, the intended result of most nursing interventions, consisting of three levels and four dimensions, was revealed by Kolcaba in 1988. Kolcaba emphasized that comfort care is a process as an attempt to achieve comfort, and that increasing comfort level is a product.

In the literature, no randomized controlled study was found in which nursing interventions based on Comfort Theory were applied to female patients with a diagnosis of SUI. In this study, it is aimed to evaluate the effect of nursing interventions based on Comfort Theory applied to female patients with a diagnosis of SUI on UI, quality of life and comfort level.

Detailed description: Urinary incontinence (UI) is seen as a common health problem among adult women. UI, defined as unconscious urinary incontinence, is not a disease, but a symptom that develops due to damage to the bladder, sphincter mechanism, or pelvic floor muscles. Different rates are expressed regarding the incidence of UI in the world. When population studies conducted in many countries are evaluated, it has been determined that the incidence of UI varies between 5% and 70%. Population-based studies have reported that UI is more common in women than men, and approximately 10% of all adult women experience UI.

Urinary incontinence can be classified as urge incontinence (UII) (involuntary leakage accompanied by urgency), stress incontinence (SUI) (involuntary leakage upon exertion or sneezing or coughing), or mixed incontinence (MUI) (involuntary leakage associated with urgency and effort, sneezing or coughing). In a prevalence study, the prevalence of any type of UI among women was found to be 53%; according to UI subtypes, 16% of women had MUI, 26% had SUI and 10% had UUI. Although many adult women experience SUI today, they see this as a natural consequence of birth and aging and do not think that it is a serious health problem. As a result of this situation, women do not attempt to apply for health services for UI. However, although UI is not life-threatening, it imposes significant limitations on women's activities of daily living and sexual and interpersonal relationships. Emotional problems such as embarrassment, depression, sadness, and low body image that UI brings with it cause a negative effect on quality of life.

Pharmacological, surgical, and behavioral treatment methods can be applied in the treatment of UI, which causes significant negative effects on quality of life. One of the behavioral treatment methods that can provide therapeutic benefits for urinary incontinence is yoga. Yoga is an ancient medical practice used to maintain bodily health and heal many types of diseases. Recently, yoga has become a new option to strengthen the pelvic floor muscles and treat symptoms related to pelvic floor dysfunctions. When the literature is examined, the results of studies showing that yoga practice is very effective in the treatment of UI have been found. Unlike most UI treatments, yoga can be practiced by women without constant supervision from healthcare providers, thus offering an accessible and cost-effective self-management strategy for large numbers of women in the community.

Nurses have important roles and responsibilities in the diagnosis, treatment, and care process of UI. Nurses need to plan and implement a care that will increase the quality of life and provide comfort for patients with UI. The word comfort, which we often use in our daily life, expresses a basic human need. Comfort is a nursing function, initiative, and also the intended outcome of most nursing interventions in the field of nursing. Kolcaba created the taxonomic structure of Comfort Theory, consisting of three levels and four dimensions, in 1988. The 3 levels within the scope of the theory were created depending on the intensity of meeting the individual comfort needs of the patients. In other words, the level of meeting the patients' needs for comfort created 3 levels of the Comfort Theory. These levels are respectively; relief, relief, and superiority. Kolcaba handled Comfort Theory in 4 dimensions taxonomically. These dimensions are based on a holistic philosophy, that is, a holistic perspective, and are named physical comfort, psychospiritual comfort, sociocultural comfort, and environmental comfort. When the taxonomic structure of Comfort Theory is evaluated, it is seen that all its components are interconnected. For example; physical comfort is related to bodily perceptions. When the individual's needs for physical responses to various stimuli are met, the individual will get rid of the distress of these responses and reach the desired comfort level. Kolcaba emphasized that comfort care is a process as an attempt to achieve comfort, and that increasing comfort level is a product.

In the literature, no randomized controlled study was found in which nursing interventions based on Comfort Theory were applied to female patients with SUI. In this study, it is aimed to evaluate the effect of nursing interventions based on Comfort Theory applied to female patients with SUI on UI, quality of life, and comfort level. In addition, it is thought that the results obtained from this study will increase awareness of practices such as yoga, meditation, and breathing exercises as an effective, applicable, and easily adaptable behavioral treatment method in female patients with a diagnosis of SUI.

AIM OF THE STUDY The aim of this study; To examine the effects of nursing interventions based on Comfort Theory applied to female patients with SUI on UI, quality of life and comfort levels.

HYPOTHESES OF THE STUDY

1. H1: Nursing interventions based on Comfort Theory have an effect on the UI level of female patients with SUI.
2. H1: Nursing interventions based on Comfort Theory have an effect on the quality of life of female patients with SUI.
3. H1: Nursing interventions based on Comfort Theory have an effect on the comfort level of female patients with SUI.

Eligibility criteria: Inclusion Criteria:

* 18 years and over
* Diagnosed with SUI
* Continuing to experience UI complaints for at least 3 months
* Who agreed to participate in the research

Exclusion Criteria:

* Diagnosed with pelvic organ prolapse
* Experienced urinary tract infection or hematuria more than 3 times in the last 1 year
* Having major neurological health problems
* Pelvic cancer patient
* Having chronic pelvic pain
* BMI\>35 kg/m2
* Having a history of urinary system surgery
* Having yoga experience in the last 1 year
* Actively doing pelvic floor exercises
* Have given birth in the last 6 months
* Pregnancy
* Having limited movement
* Alcohol/drug addiction

Primary outcomes:
measure: Incontinence Severity Index (ISI)
timeFrame: 6 week
Secondary outcomes:
measure: Urinary Incontinence Quality of Life Scale (IQO-L)
timeFrame: 6 week
Other outcomes:
measure: Urinary Incontinence and Frequency Comfort Scale
timeFrame: 6 week
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
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