Urinary IncontinenceNCT05589194
Comfort Theory-Based Nursing Interventions in Women with Stress Urinary Incontinence
A study testing Nursing Practices Based on Kolcaba's Comfort Theory in people with Urinary Incontinence, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Nursing Practices Based on Kolcaba's Comfort Theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over
- Diagnosed with SUI
- Continuing to experience UI complaints for at least 3 months
- Who agreed to participate in the research
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Nursing Practices Based on Kolcaba's Comfort Theory
- Keywords
- Urinary Incontinence, Comfort Theory, Yoga, Nursing
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Practices Based on Kolcaba's Comfort TheoryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
Secondary outcomes (1)
Urinary Incontinence Quality of Life Scale (IQO-L)
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start21 Dec 2022
- Primary completion1 Jun 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a randomized controlled single-blind quasi-experimental research design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Gamze Hakbilen, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589194
- Sponsor's protocol ID
- AkdenizNursing
- Status last verified
- Jul 2024
- First submitted
- 18 Oct 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
PubMed 12559262Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
PubMed 28681849Charalambous S, Trantafylidis A. Impact of urinary incontinence on quality of life. Pelviperineology. 2009; 28: 51-53.
Hagglund D, Walker-Engstrom ML, Larsson G, Leppert J. Reasons why women with long-term urinary incontinence do not seek professional help: a cross-sectional population-based cohort study. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Nov;14(5):296-304; discussion 304. doi: 10.1007/s00192-003-1077-9. Epub 2003 Aug 29.
PubMed 14618304Huang AJ, Chesney M, Lisha N, Vittinghoff E, Schembri M, Pawlowsky S, Hsu A, Subak L. A group-based yoga program for urinary incontinence in ambulatory women: feasibility, tolerability, and change in incontinence frequency over 3 months in a single-center randomized trial. Am J Obstet Gynecol. 2019 Jan;220(1):87.e1-87.e13. doi: 10.1016/j.ajog.2018.10.031. Epub 2018 Oct 26.
PubMed 30595143Huang AJ, Jenny HE, Chesney MA, Schembri M, Subak LL. A group-based yoga therapy intervention for urinary incontinence in women: a pilot randomized trial. Female Pelvic Med Reconstr Surg. 2014 May-Jun;20(3):147-54. doi: 10.1097/SPV.0000000000000072.
PubMed 24763156Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.
PubMed 21231991Kim GS, Kim EG, Shin KY, Choo HJ, Kim MJ. Combined pelvic muscle exercise and yoga program for urinary incontinence in middle-aged women. Jpn J Nurs Sci. 2015 Oct;12(4):330-9. doi: 10.1111/jjns.12072. Epub 2015 Feb 23.
PubMed 25705816Kim HS. A study on self-esteem, depression, anxiety, and discomfort of daily life due to urinary incontinence in women. Journal of Korean Academy of Psychiatric and Mental Health Nursing. 2001; 10: 98-106.
Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.
PubMed 16060582Kolcaba K. Comfort Theory and Practice: A Vision for Holistic Health Care and Research. New York: Springer Publishing. 2003: 15-49.
Kolcaba KY. A taxonomic structure for the concept comfort. Image J Nurs Sch. 1991 Winter;23(4):237-40. doi: 10.1111/j.1547-5069.1991.tb00678.x.
PubMed 1937522Kolcaba KY. Comfort as process and product, merged in holistic nursing art. J Holist Nurs. 1995 Jun;13(2):117-31. doi: 10.1177/089801019501300203.
PubMed 7745238Kwon BE, Kim GY, Son YJ, Roh YS, You MA. Quality of life of women with urinary incontinence: a systematic literature review. Int Neurourol J. 2010 Oct;14(3):133-8. doi: 10.5213/inj.2010.14.3.133. Epub 2010 Oct 31.
PubMed 21179330Lee UJ, Feinstein L, Ward JB, Kirkali Z, Martinez-Miller EE, Matlaga BR, Kobashi KC. Prevalence of Urinary Incontinence among a Nationally Representative Sample of Women, 2005-2016: Findings from the Urologic Diseases in America Project. J Urol. 2021 Jun;205(6):1718-1724. doi: 10.1097/JU.0000000000001634. Epub 2021 Feb 19.
PubMed 33605795
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05589194
- Acronym / sponsor ID
- AkdenizNursing
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Comfort Theory, Yoga, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research is a randomized controlled single-blind quasi-experimental research design.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Nursing Practices Based on Kolcaba's Comfort TheoryAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and over
- Diagnosed with SUI
- Continuing to experience UI complaints for at least 3 months
- Who agreed to participate in the research
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Practices Based on Kolcaba's Comfort TheoryNursing 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. | Behavioural | Intervention Group |
Primary outcome
Incontinence Severity Index (ISI)
Time frame: 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.
1 secondary outcome
Urinary Incontinence Quality of Life Scale (IQO-L)
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 12559262Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
- Background: PubMed 28681849Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
- BackgroundCharalambous S, Trantafylidis A. Impact of urinary incontinence on quality of life. Pelviperineology. 2009; 28: 51-53.
- Background: PubMed 14618304Hagglund D, Walker-Engstrom ML, Larsson G, Leppert J. Reasons why women with long-term urinary incontinence do not seek professional help: a cross-sectional population-based cohort study. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Nov;14(5):296-304; discussion 304. doi: 10.1007/s00192-003-1077-9. Epub 2003 Aug 29.
- Background: PubMed 30595143Huang AJ, Chesney M, Lisha N, Vittinghoff E, Schembri M, Pawlowsky S, Hsu A, Subak L. A group-based yoga program for urinary incontinence in ambulatory women: feasibility, tolerability, and change in incontinence frequency over 3 months in a single-center randomized trial. Am J Obstet Gynecol. 2019 Jan;220(1):87.e1-87.e13. doi: 10.1016/j.ajog.2018.10.031. Epub 2018 Oct 26.
- Background: PubMed 24763156Huang AJ, Jenny HE, Chesney MA, Schembri M, Subak LL. A group-based yoga therapy intervention for urinary incontinence in women: a pilot randomized trial. Female Pelvic Med Reconstr Surg. 2014 May-Jun;20(3):147-54. doi: 10.1097/SPV.0000000000000072.
- Background: PubMed 21231991Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.
- Background: PubMed 25705816Kim GS, Kim EG, Shin KY, Choo HJ, Kim MJ. Combined pelvic muscle exercise and yoga program for urinary incontinence in middle-aged women. Jpn J Nurs Sci. 2015 Oct;12(4):330-9. doi: 10.1111/jjns.12072. Epub 2015 Feb 23.
- BackgroundKim HS. A study on self-esteem, depression, anxiety, and discomfort of daily life due to urinary incontinence in women. Journal of Korean Academy of Psychiatric and Mental Health Nursing. 2001; 10: 98-106.
- Background: PubMed 16060582Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.
- BackgroundKolcaba K. Comfort Theory and Practice: A Vision for Holistic Health Care and Research. New York: Springer Publishing. 2003: 15-49.
- Background: PubMed 1937522Kolcaba KY. A taxonomic structure for the concept comfort. Image J Nurs Sch. 1991 Winter;23(4):237-40. doi: 10.1111/j.1547-5069.1991.tb00678.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Practices Based on Kolcaba's Comfort Theory in people with Urinary Incontinence, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Severity Index (ISI) (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589194, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.