NCT05589194

Comfort Theory-Based Nursing Interventions in Women with Stress Urinary Incontinence

Completed NA Last updated 29 January 2025

What this trial tests

NA trial testing Nursing Practices Based on Kolcaba's Comfort Theory in Urinary Incontinence in 40 participants. Completed in 10 January 2025.

Timeline

21 December 2022

Primary endpoint
1 June 2024

10 January 2025

Quick facts

Lead sponsor	Akdeniz University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	40
Start date	21 December 2022
Primary completion	1 June 2024
Estimated completion	10 January 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Nursing Practices Based on Kolcaba's Comfort Theory

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →

Sponsor

Akdeniz University

Who can join

18 and older, female only, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.