Comfort Theory-Based Nursing Interventions in Women with Stress Urinary Incontinence
NCT ID: NCT05589194
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2022-12-21
2025-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients
NCT05791903
The Effectiveness of a Stress Incontinence Care Protocol
NCT03866356
Use of Comfort Theory In Intensive Care
NCT06781671
The Effect of Music Therapy in COVID-19 Patients Given Prone Position
NCT05038514
The Effect of Mindfulness Program on Clinical Stress Nursing Students
NCT06259955
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with SUI
* Continuing to experience UI complaints for at least 3 months
* Who agreed to participate in the research
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akdeniz University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hilal Gamze Hakbilen
Research Assistant
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akdeniz University
Antalya, Antalya, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Aoki 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.
Charalambous 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.
Huang 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.
Huang 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.
Irwin 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.
Kim 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.
Kim 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.
Kolcaba 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.
Kolcaba KY. Comfort as process and product, merged in holistic nursing art. J Holist Nurs. 1995 Jun;13(2):117-31. doi: 10.1177/089801019501300203.
Kwon 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.
Lee 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.
Mills C, Evans A, Rogers T. Is yoga an effective treatment of urinary incontinence in women?. Evidence-Based Practice. 2021; 24(4): 41-42.
Milsom I, Gyhagen M. The prevalence of urinary incontinence. Climacteric. 2019 Jun;22(3):217-222. doi: 10.1080/13697137.2018.1543263. Epub 2018 Dec 21.
Milsom I, Altman D, Cartwright R, et al. Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal (AI) incontinence. In: Abrams 22. P, Cardozo L, Wagg A, Wein A, eds. Incontinence. 6th ed. Paris: Health Publications Ltd; 2016:17-24.
Nayak G, Kamath A, Kumar PN, Rao A. Effect of yoga therapy on physical and psychological quality of life of perimenopausal women in selected coastal areas of Karnataka, India. J Midlife Health. 2014 Oct;5(4):180-5. doi: 10.4103/0976-7800.145161.
Ozcan M, Kapucu S. Nursing approach in elderly patients with urinary ıncontinence. Journal of Hacettepe University Faculty of Nursing. 2014; 101-109.
Parker ME, Smith MC. Nursing Theories And Nursing Practice. Philadelphia: Davis Company. 2010: 389-401.
Rathore M, Agrawal S, Nayak PK, Sinha M, Sharma DK, Mitra S. Exploring the significance of
Sweta KM, Godbole A, Awasthi HH, Pandey U. Effect of Mula Bandha Yoga in Mild Grade Pelvic Organ Prolapse: A Randomized Controlled Trial. Int J Yoga. 2018 May-Aug;11(2):116-121. doi: 10.4103/ijoy.IJOY_32_17.
Tenfelde S, Tell D, Garfield L, Mathews H, Janusek L. Yoga for Women With Urgency Urinary Incontinence: A Pilot Study. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):57-62. doi: 10.1097/SPV.0000000000000723.
Terzi B, Kaya N. Comfort Theory and analysis. Journal of Anatolia Nursing and Health Sciences. 2017; 20(1): 67-74.
Tunuguntla R, Tunuguntla HSGR, Kathuria H, Verma S. Effectiveness of App-Based Yoga of Immortals (YOI) Intervention for Insomnia in Asian Population during Pandemic Restrictions. Int J Environ Res Public Health. 2021 May 26;18(11):5706. doi: 10.3390/ijerph18115706.
Vinchurkar SA, Arankalle DV. Integrating yoga therapy in the management of urinary incontinence: a case report. J Evid Based Complementary Altern Med. 2015 Apr;20(2):154-6. doi: 10.1177/2156587214563311. Epub 2014 Dec 24.
Sandvik H, Hunskaar S, Seim A, Hermstad R, Vanvik A, Bratt H. Validation of a severity index in female urinary incontinence and its implementation in an epidemiological survey. J Epidemiol Community Health. 1993 Dec;47(6):497-9. doi: 10.1136/jech.47.6.497.
Hazar UH, Şirin A. Validity and reliability study of incontinence severity index. Journal Of Adnan Menderes University Medical Faculty. 2008; 9(3): 5-8.
Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996 Jan;47(1):67-71; discussion 71-2. doi: 10.1016/s0090-4295(99)80384-7.
Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP. Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999 Jan;53(1):71-6. doi: 10.1016/s0090-4295(98)00454-3.
Ozerdoğan N, Kızılkaya NB. The prevalence and risk factors of urinary incontinence and its influence on the quality of life in 20 years or older of women in Eskişehir, Afyon, Kütahya, Bilecik cities. Florence Nightingale Journal of Nursing 2003;51:37-50.
Dowd T, Kolcaba K, Steiner R. Using cognitive strategies to enhance bladder control and comfort. Holist Nurs Pract. 2000 Jan;14(2):91-103. doi: 10.1097/00004650-200001000-00013.
Zengin N. Effects of nursing education and behavioral therapy on comfort, pelvic muscle exercise self-efficacy and quality of life among women with urinary incontinence. Marmara University Institute of Health Sciences, PhD Thesis, 2008, Istanbul.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AkdenizNursing
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.