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

NCT05589194 | Completed DMC

• 1 other identifier: AkdenizNursing
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Comfort Theory; Yoga; Nursing

Outcome Measures

Primary Outcomes (1)

• Incontinence Severity Index (ISI)

  Incontinence Severity Index (ISI) will be used to determine the UI severity of the participants. The ISI is a short scale developed by Sandvik et al., which is easily applied to individuals with urinary incontinence. The ISI is an assessment tool consisting of two questions that evaluate the frequency and amount of incontinence. The result regarding the severity of incontinence is calculated by multiplying the scores obtained from the questions. The results obtained are "Mild" (1 and 2 points), "Moderate" (3, 4 and 6 points), "Severe" (8 and 9 points) and "Very Severe" (12 points) are divided into four groups.

  6 week

Secondary Outcomes (1)

• Urinary Incontinence Quality of Life Scale (IQO-L)

  6 week

Other Outcomes (1)

• Urinary Incontinence and Frequency Comfort Scale

  6 week

Study Arms (2)

Intervention Group

EXPERIMENTAL

After the first interview with the patients in the intervention group, a phone call will be made for regarding the implementation of nursing interventions based on the Comfort Theory, and they will be informed about the planned dates for the implementation. The implementation phase of nursing interventions based on Comfort Theory will be carried out for 6 weeks at the Communication Laboratory of the Faculty of Nursing of Akdeniz University on the planned dates with the patients. In addition, a handbook will be given to the patients at the beginning of the practice, and the Home Yoga Diary in the handbook will be expected to be filled in daily by the patients during the research. Immediately after the implementation of the nursing interventions based on Comfort Theory (week 6), patients will be asked to fill in ISI, IQO-L, and the Urinary Incontinence and Frequency Comfort Scale. During this whole process, patients will continue their planned routine care and treatment.

Behavioral: Nursing Practices Based on Kolcaba's Comfort Theory

Control Group

NO INTERVENTION

After the first interview with the patients in the control group, the routine care and treatment practices planned by the polyclinic physician and nurse will continue. No additional intervention is planned for the patients in this group. A new interview will be planned with the patients in the control group 6 weeks after the first interview, and they will be asked to fill in the ISI, IQO-L, and the Urinary Incontinence and Frequency Comfort Scale.

Interventions

Nursing Practices Based on Kolcaba's Comfort Theory BEHAVIORAL

Nursing interventions planned to be carried out within the scope of the research will be based on Comfort Theory. Nursing interventions will be planned according to the needs in the physical comfort (diet practice, providing effective and correct pelvic floor muscle contraction, repetitive and regular yoga practice training), psychospiritual comfort (appreciation and encouragement, self-confidence, expressing the feeling of embarrassment, expressing fear, confidence, repetitive and regular practice of yoga practice, meditation), sociocultural comfort (to be informed, to develop effective interpersonal communication, to interact with other women with SUI) and environmental comfort (Informing about making the necessary arrangements to prevent possible situations such as sleep disruption and falling, bad smell, etc. and performing nursing practices by respecting privacy). The yoga practice will carry out with the participation of 60-minute group yoga classes twice a week for 6 weeks.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will be limited to female patients with a diagnosis of SUI.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Antalya, 07070, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the randomization process, those who meet the criteria for inclusion in the sample and accept to participate in the study do not know that they will be included in the intervention group or the control group, so it will be single-blind.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The research is a randomized controlled single-blind quasi-experimental research design.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: December 21, 2022
• Primary Completion: June 1, 2024
• Study Completion: January 10, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)