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

Sponsor

Akdeniz University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05589194

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Behavioral: Nursing Practices Based on Kolcaba's Comfort Theory	N/A

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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 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.
No Intervention: Control Group 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.

Arm

Intervention/Treatment

Experimental: Intervention Group

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

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.

No Intervention: Control Group

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.

Outcome Measures

Primary Outcome Measures

Incontinence Severity Index (ISI) [6 week]
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.

Secondary Outcome Measures

Urinary Incontinence Quality of Life Scale (IQO-L) [6 week]
The Urinary Incontinence Quality of Life Scale (IQO-L) was developed by Wagner et al. to determine the quality of life of patients with UI. The IQO-L was later re-evaluated by Patrick et al. in 1999. In the process of creating the European versions of the scale, 6 questions were removed with the evaluation of psychometric measurements, and the number of questions was reduced to 22. In the IQO-L, all items are evaluated on a 5-point Likert-type scale (1 = a lot, 2 = a lot, 3 = moderately, 4 = a little, 5 = not at all). The total score calculated on the scale is converted to a scale value from 0 to 100 for better understanding. The IQO-L limiting behaviors (1st,2nd,3rd,4th,10th,11th,13th,20th items), psychological influence (5th,6th,7th,9th,15th. ,16.,17.,21.,22. items) and limiting social life (8.,12.,14.,18.,19). High scores indicate that the quality of life is better than low scores.

Other Outcome Measures

Urinary Incontinence and Frequency Comfort Scale [6 week]
Urinary Incontinence and Frequency Comfort Scale was developed by Dowd et al. using Kolcaba's General Comfort Scale to evaluate the comfort of individuals with UI and urination problems. The scale includes the comfort of an individual with urinary incontinence in four dimensions: physical, psychospiritual, sociocultural and environmental; It contains 28 expressions that evaluate at three levels as relief, relief, and superiority. Each statement in the scale has a Likert-type rating ranging from 1 to 6 from "Strongly Disagree" to "Strongly Agree". 16 of the expressions are positive (1, 2, 4, 9, 11, 12, 13, 15, 16, 17, 23, 24, 25, 26, 27, 28), 12 negative (3, 5, 6, 7, 8, 10, 14, 18, 19, 20, 21, 22); negative statements are reversed in scoring. The highest total score that can be obtained from the scale is 168, and the lowest score is 28. A low score indicates bad comfort, and a high score indicates good comfort.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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