DO NOT DUPLICATE. Changes in the demographic transition process have increased life expectancy,

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1 ORIGINAL RESEARCH WOUNDS 2012;24(5): From the Division of Plastic Surgery, Federal University of São Paulo UNIFESP, Brazil Address correspondence to: Geraldo Magela Salomé, RN, DHSc Division of Plastic Surgery UNIFESP Rua Napoleão de Barros 715, 4o andar, Vila Clementino CEP São Paulo, SP, Brazil 124 WOUNDS Sleep Quality Among Patients With Venous Ulcers: A Cross-sectional Study in a Health Care Setting in São Paulo, Brazil Geraldo Magela Salomé, RN, DHSc; Donata Maria de Souza Pellegrino, RN, ET; Thais Fernanda Vieira, RN; Leila Blanes, RN, PhD; Lydia Masako Ferreira, MD, PhD Abstract: This was an exploratory, descriptive, cross-sectional study to assess sleep quality in 100 patients with venous ulcers using the Pittsburgh Sleep Quality Index (PSQI). Thirty-six (36%) patients had a global PSQI score < 5, indicating that they were good sleepers, while 64 (64%) patients were considered poor sleepers. Fifty-three (53%) patients reported going to bed between 9:00 pm and 11:00 pm, 63 (63%) taking from 16 to 30 minutes to fall asleep, and 41 (41%) waking up after 4 to 5 hours of sleep. Sixty (60%) patients regarded sleeping as a necessity. Most patients with venous ulcers experienced poor sleep quality. Changes in the demographic transition process have increased life expectancy, leaving the population susceptible to chronic degenerative diseases. 1 Leg ulcers have become more common in patients with chronic diseases, particularly those of the circulatory system. These ulcers may be caused by factors, such as vascular, metabolic, and hematologic changes, with venous insufficiency being the main cause of leg ulcers in many developed countries. 2,3 Chronic venous insufficiency can be defined as changes in the functioning of the venous system caused by venous valvular incompetence. Its prevalence ranges from 2% to 7% in the adult population. Nearly 47% of cases affect the superficial venous system, and 53% affect the deep venous system. 3 6 Venous ulcers cause pain, depression, social isolation, loss of self-esteem, degraded self-image, lifestyle changes, reduced sleep quality and quality of life, and limits the ability of patients to perform normal daily activities. The prevalence of venous ulcers ranges from 0.5% to 1.5% in the adult population. 3,4,7,8 Since sleep is a physiological and behavioral process that is essential for the proper functioning of the human body, sleep quality, as experienced by the patient and its impact on the daily life of healthy persons or persons with diseases, has been the focus of many studies. 9,10 The measurement of sleep quality has become an important clinical tool to identify health problems. 9 Sleep disturbances may be associated with fatigue, mood changes, and decreased pain tolerance. 11 Moreover, impaired sleep may lead to metabolic dysfunctions because hormones, which play a vital role in the functioning of the body, are

2 produced and released during the sleep cycle. Aside from hormonal changes, irregular sleep patterns may result in reduced ability to plan and perform tasks, irritability, mood changes, and difficulty concentrating in the short-term, and may cause early aging and cardiovascular diseases over the long-term. All of these factors acting together in patients with venous ulcers may impair wound healing Patients with chronic or acute ulcers have an increased risk for sleep disorders, particularly if hospitalization is required. 15 It is believed that patients with venous ulcers tend to have more trouble falling asleep and staying asleep compared with other clinical patients, because this condition is usually associated with other comorbidities, such as vascular diseases, diabetes, and hypertension. Hospitalization and other changes in the sleep routine may result in sleep disorders in these patients and exacerbate problems caused by chronic diseases Questionnaires may be used to assess and measure sleep quality in patients with venous ulcers. The Pittsburgh Sleep Quality Index (PSQI) was chosen for this study because it is an instrument designed to measure subjective sleep quality and sleep disturbances. 9 The PSQI had been translated into Brazilian Portuguese and was culturally validated, while maintaining its high sensitivity (80%) and specificity (69.8%). 15 Patients with venous ulcers require care from a multidisciplinary team working in unison with the purpose of improving treatment approaches and cost-effectiveness, which can lead to better sleep quality. DaVanzo et al 18 reported statistical improvement outcomes and lower Medicare costs ($ versus $ per resident episode day; P < 0.01) in skilled nursing facility residents with chronic wounds treated by a wound management Keypoints Irregular sleep patterns may result in reduced ability to plan and perform tasks, irritability, mood changes, and difficulty concentrating in the short-term, and may cause early aging and cardiovascular diseases over the long-term. All of these factors acting together in patients with venous ulcers may impair wound healing Patients with venous ulcers require care from a multidisciplinary team working in unison, with the purpose of improving treatment approaches and cost-effectiveness, which can lead to better sleep quality. DaVanzo et al 18 reported statistical improvement outcomes and lower Medicare costs ($ versus $ per resident episode day; P < 0.01) team compared with those who did not receive care from the wound management team. The aim of this study was to assess the sleep quality in patients with venous ulcers. Methods This was an exploratory, descriptive, cross-sectional study. The Research Ethics Committee of the Universidade Federal de São Paulo (UNIFESP), Brazil, approved the study. Written informed consent was obtained from all patients prior to their inclusion in the study, and steps were taken to ensure patient anonymity. Data were collected between December 2008 and December One hundred patients with venous ulcers who attended the outpatient wound care clinic of a hospital center in the state of São Paulo, Brazil, participated in this study. Eligibility criteria included patients with venous ulcers who were 18 years or older and were attending the outpatient wound care clinic. Patients who were not physically or mentally able to complete the questionnaire, and those with mixed ulcers, arterial ulcers, foot ulcers, and wounds other than venous ulcers, were excluded from the study. Sleep quality was assessed using the PSQI, which is a questionnaire designed to measure subjective sleep quality and sleep disturbances. 9 The Brazilian Portuguese version of the PSQI 15 was administered to all patients in a private room to ensure comfort and tranquility. The questionnaire consists of 10 items (some containing multiple subitems), of which 4 (items 1 to 4) are presented as open-ended questions, and 6 (items 5 to 10) as semi-open questions. The items are grouped into 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. Each component is scored from 0 to 3. The global PSQI score is calculated as the sum of ratings for the 7 components for a possible range of 0 to 21, with a cut-off score of 5 (a higher score indicates poorer sleep quality). A global PSQI score > 5 indicates that a person is a poor sleeper. 9,15 Statistical Analysis Statistical analysis was carried out using the Statistical Package for the Social Sciences (SPSS) version 15.0 (SPSS Inc, Chicago, IL). The chi-square test, Student s t test, nonparametric Mann-Whitney U test, and Kruskal-Wallis test, followed by the post-hoc Dunn s multiple comparison test, were used. Statistical significance was set at P < 0.05 for all tests. Vol. 24, No. 5 May

3 Keypoints Sleep quality was assessed using the PSQI, which is a questionnaire designed to measure subjective sleep quality and sleep disturbances. 9 The Brazilian Portuguese version of the PSQI, 15 which had been culturally validated for use in Brazil, was administered to all patients in a private room to ensure comfort and tranquility. Table 1. Global PSQI Scores for patients with venous ulcers (n = 100). Results Thirty-six (36%) patients with venous ulcers had global PSQI scores 5, indicating good sleep quality, while 64 (64%) patients had poor sleep quality (Table 1). The sociodemographic data show that 51 (51%) were men, 59 (59%) were 60 years and older, 78 (78%) were white, and 45 (45%) were married (Table 2). It was also observed that 29 (29%) patients had diabetes mellitus, and 61 (61%) had high blood pressure (Table 3). Global PSQI scores n % Valid % Cumulative % 5 (good sleepers) > 5 (poor sleepers) Table 2. Sociodemographic characteristics of the patients with venous ulcers (n = 100). Variables Age groups (years) No. patients n % Valid % Cumulative % Race White Other Sex Male Female Marital status Married Divorced Single Widowed No information WOUNDS

4 Table 3. Clinical characteristics of the patients with venous ulcers (n = 100). Variables No. patients n % Valid % Cumulative % Diabetes mellitus No Yes Arterial hypertension Yes No Sleep patterns. Fifty-three (53%) patients went to sleep between 9:00 pm and 11:00 pm, 63 (63%) took between 31 and 60 minutes to fall asleep, 53 (53%) woke up between 4:00 am and 5:00 am, and 41 (41%) slept 4 to 5 hours per night. There were significant differences (P < 0.001) in the distribution of responses across categories in all open-ended questions (Table 4). The results also revealed that 34 (34%) patients took more than 30 minutes to fall asleep, 92 (92%) woke up in the middle of the night or early in the morning, 90 (90%) woke up to use the bathroom, 88 (88%) had bad dreams or nightmares, 12 (12%) took medication to sleep, and 87 (87%) had trouble staying awake while driving (Table 5). There were significant differences (P < 0.001) in the distribution of responses across different response categories in all semiopen questions (Table 5). Forty (40%) patients considered sleep a necessity, 60 (60%) took intentional daytime naps, and 40 (40%) reported a need for daytime naps (Table 6). Discussion Chronic ulcers are painful, difficult to heal, and may present odor and exudate. The presence of ulcers may reduce the mobility and autonomy of patients, interfere with their professional life, and result in social isolation and low self-esteem. All of these factors combined may contribute to poor sleep quality and reduced quality of life. 8 Therefore, it is important to assess sleep quality in patients with venous ulcers. Some studies have reported on the negative impact of chronic diseases on sleep quality, reduced sleep duration, prolonged time to fall asleep, 16,23 and a strong association between chronic diseases and sleep disorders. 24 Disturbed subjective sleep quality was reported by van Dijk et al 17 in adult patients with longstanding type 1 diabetes mellitus, and by Luyster et al 16 in patients with rheumatoid arthritis. The present study showed that most patients with venous ulcers (64%) experienced poor sleep quality; however, the venous ulcer with associated pain, odor, fear of complications or amputation, and financial concerns may not be the sole cause. Other factors that cause poor sleep in this population include age-related illnesses, nocturia, issues related to marital status, a morning-type orientation, irregularity in bed times and rise times, functional disability, and cognitive impairment. Sleep-disordered breathing, periodic limb movements in sleep, restless legs syndrome, morning headaches, circadian rhythm disorders, excessive daytime sleepiness, obstructive sleep apnea syndrome, and insomnia, are age-related factors that may also be associated with poor sleep. 16,25 28 The study population was predominantly (59%) older adults (age > 60 years). Many older adults have sleep issues associated with age-related physiological changes or secondary to medical illness Studies have shown that older adults spend more time in bed and wake up during the night more often than younger adults, and that they experience insomnia and hyposomnia more frequently, which are often secondary to other conditions. 29 Unsatisfactory sleep quality or insufficient sleep are very unpleasant experiences and may affect performance, behavior, and sense of well-being during daily activities. 30 It was also observed that 45 (45%) patients were married and reported poor sleep quality, indicating that the marital status of patients may interfere with their sleep quality. 30 Sleep disturbances may be related to the presence or absence of a partner. Patients without a partner may have feelings of fear, which may influence the sleep pattern. 31 Twenty-nine patients (29%) had diabetes and 61 (61%) had hypertension. In patients with diabetes, sleep may be interrupted by nocturia, which compromises sleep quality. Daytime sleepiness may be one sign of changes in sleep quality. 32 Bad dreams and nightmares were re- Vol. 24, No. 5 May

5 Table 4. Responses to open-ended PSQI questions (n = 100). Questions What time do you usually go to bed at night? Responses n % 7:00 pm to 9:00 pm :00 pm to 11:00 pm :00 pm to 1:00 am :00 am to 3:00 am :00 am to 5:00 am How long does it usually take you to fall asleep? Up to 15 min to 30 min to 60 min More than 60 min What time do you usually wake in the morning? 3:00 am to 4:00 am :00 am to 5:00 am :00 am to 6:00 am :00 am to 7:00 am > 7:00 am How many hours do you sleep at night? 1 to 2 h to 3 h P* < < < to 4 h to 5 h to 6 h < to 7 h to 8 h to 9 h to 10 h *Non-parametric Kruskal-Wallis test 128 WOUNDS

6 Table 5. Responses to the semi-open PSQI questions (n = 100). Questions Never Less than once a week Once or twice a week Three or more times a week Total n % n % n % n % N % Cannot get to sleep within 30 minutes Wake up in the middle of the night or early morning Have to get up to use the bathroom Cannot breathe comfortably Cough or snore loudly Feel too cold Feel too hot Have bad dreams or nightmares Have a good night s sleep Have taken medication to help sleep Have had trouble staying awake while driving It has been a problem maintaining enough enthusiasm to get things done ported by 88% of the patients, which may be related to psychological factors, such as stress and anxiety. In stressful situations, there is a hypersecretion of cortisol, which is associated with insulin resistance. 16,17,26,30 Regarding PSQI item 10, 60 (60%) patients took intentional daytime naps, and 40 (40%) patients reported daytime naps as a necessity, and not a pleasure (Table 6). Daytime naps may be associated with sleep interruptions at night, which contribute to poor sleep quality. Currently, nap episodes and sleep interruptions at night are considered to be part of the natural sleep/wake cycle, but remains a controversial issue. An experimental study showed that sleep deprivation could trigger insulin resistance. 26 Most of the patients went to sleep between 9:00 pm and 11:00 pm (n = 53), took between 31 and 60 minutes Vol. 24, No. 5 May

7 Table 6. Responses to item 10 of the PSQI (n = 100). Questions n % P* For you, sleep is a: Pleasure Necessity Do you take daytime naps? Yes No If your answer is yes, do you take intentional naps? Yes No For you, napping is a: Pleasure Necessity *Non-parametric Kruskal-Wallis test to fall asleep (n = 63), woke up between 4:00 am and 5:00 am (n = 53), and slept 4 to 5 hours per night (n = 41). These results are similar to the Luyster et al 16 study in which patients with rheumatoid arthritis reported symptoms of depression, fatigue, functional impairment, and sleeping for 6.6 hours per night on average; one-third of the participants reported having pain that disturbed their sleep 3 or more times per week. An adult needs about 7 hours of sleep per night, but the amount of sleep needed decreases with age. It is important to note that the number of hours of sleep needed varies among individuals, and an individual can feel rested even after a short period of sleep. 31 When PSQI component scores are evaluated with the global PSQI score, it is possible to understand the relationship between them, because a person who had slept for less than 5 hours, and taken more than 30 minutes to fall asleep, is considered to have poor sleep quality, and consequently, might be sleepy during the day and feel the need for daytime naps. In order to assess sleep quality, the sleep pattern of patients should be determined. To this end, health care professionals should assess the patient s daily routine to determine the time they go to sleep, how long they take to fall asleep, sleep duration, the number of times they wake up at night, how long they take to fall asleep again, and what time they wake in the morning WOUNDS Keypoints The present study showed that most patients with venous ulcers (64%) experience poor sleep quality; however, the venous ulcer with associated pain, odor, fear of complications or amputation, and financial concerns may not be the sole cause. Other factors that cause poor sleep in this population include age-related illnesses, nocturia, issues related to marital status, a morning-type orientation, irregularity in bed times and rise times, functional disability, and cognitive impairment. Therefore, it is important to note that daytime naps may be necessary for some patients, but may adversely affect nighttime sleep. The present results reaffirm the importance of sleep quality among patients with venous ulcers. Currently, an instrument to specifically assess sleep quality in patients with venous ulcers does not exist. This study may help health care professionals increase their knowledge on factors that interfere with sleep quality and sleep patterns, facilitating the search for effective interventions in order to improve sleep quality in patients with venous ulcers. Conclusion It is not possible to state conclusively that venous ulcers are responsible for poor sleep quality, but alterations in sleep quality were observed in the study population. Thus, the results reaffirm the need to implement a holistic approach to care for patients with venous ulcers. This holistic approach should aim to identify alterations in patients sleep patterns, and should be implemented in health care settings, such as hospitals, outpatient clinics, and home-based care, among others. It is also important to identify any significant health care needs, and to evaluate the capacity of the caregiver to control this type of condition. References 1. Otero LM, Zanetti ML, Teixeira CR. [Sociodemographic and clinical characteristics of a diabetic population at a primary level health care center]. Rev Lat Am Enfermagem. 2007;15: [Article in Portuguese] 2. Figueiredo M. [Scientific evidence of compression treatment]. J Vasc Bras. 2009;8: [Article in Portuguese] 3. Callam MJ. Epidemiology of varicose veins. Br J Surg.1994;81(2): Nicolaides AN. Chronic venous disease and the leukocyte-

8 endothelium interaction: from symptoms to ulceration. Angiology. 2005;56(Suppl 1):S Clarke-Moloney M, O Brien JF, Grace PA, Burke PE. Healthrelated quality of life during four-layer compression bandaging for venous ulcer disease: a randomised controlled trial. Ir J Med Sci. 2005;174(2): Abbade LPF, Lastória S. [Management of patients with venous leg ulcer]. An Bras Dermatol. 2006;81: [Article in Portuguese] 7. Yamada BFA, Santos VLC. Quality of life of individuals with chronic venous ulcers. WOUNDS. 2005;17(7): Salomé GM, Pellegrino MPD, Blanes L, Ferreira LM. Selfesteem in patients with diabetes mellitus and foot ulcers. J Tissue Viability. 2011;20(3): Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2): Lima J, Rossini S, Reimão R. Sleep disorders and quality of life of harvesters rural labourers. Arq Neuropsiquiatr. 2010;68(3): Engstrom CA, Strohl RA, Rose L, Lewandowski L, Stefanek ME. Sleep alterations in cancer patients. Cancer Nurs. 1999;22(2): Almeida GPL, Lopes HF. The metabolic syndrome and sleep disorders. Rev Soc Cardiol Estado São Paulo. 2004;14: Salomé GM, Espósito VH. [Nursing students experiences while caring people with wounds]. Rev Bras Enferm. 2008;61(6): [Article in Portuguese] 14. Salomé GM, Blanes L, Ferreira LM. [Functional capability of patients with diabetes with foot ulceration]. Acta Paul Enferm. 2009;22(4): [Article in Portuguese] 15. Bertolazi AN. Translation, cultural adaptation, and validation of two sleep assessment instruments: the Epworth sleepiness scale and Pittsburgh Sleep Quality score [master s thesis in Portuguese]. Porto Alegre, RS: Universidade Federal do Rio Grande do Sul; Available at: Accessed: November 15, Luyster FS, Chasens ER, Wasko MC, Dunbar-Jacob J. Sleep quality and functional disability in patients with rheumatoid arthritis. J Clin Sleep Med. 2011;7(1): van Dijk M, Donga E, van Dijk JG, et al. Disturbed subjective sleep characteristics in adult patients with long-standing type 1 diabetes mellitus. Diabetologia. 2011;54(8): DaVanzo JE, El-Gamil AM, Dobson A, Sen N. A retrospective comparison of clinical outcomes and Medicare expenditures in skilled nursing facility residents with chronic wounds. Ostomy Wound Manage. 2010;56(9): Corrêa K, Ceolim MF. [Sleep quality in aged patients with peripheral vascular diseases]. Rev Esc Enferm USP. 2008;42(1): Rezende MM, Ghezzi SR, Fukujima MM, et al. [Analysis of assessment instruments of sleep quality in Amyotrophic Lateral Sclerosis (ALS) patients]. Rev Neurosci. 2008;16(1): [Article in Portuguese] 21. Furlani R, Ceolim MF. [Sleep quality of women with gynecological and breast cancer]. Rev Lat Am Enfermagem. 2006;14(6): [Article in Portuguese] 22. Barichello E, Sawada NO, Sonobe HM, Zago MM. Quality of sleep in postoperative surgical oncologic patients. Rev Lat Am Enfermagem. 2009;17(4): Barclay NL, Eley TC, Buysse DJ, Rijsdijk FV, Gregory AM. Genetic and environmental influences on different components of the Pittsburgh Sleep Quality Index and their overlap. Sleep. 2010;33(5): Pandi-Perumal SR, Seils LK, Kayumov L, et al. Senescence, sleep, and circadian rhythms. Ageing Res Rev. 2002;1(3): Mazza M, Della Marca G, De Risio S, Mennuni GF, Mazza S. Sleep disorders in the elderly. Clin Ter. 2004;155(9): Ancoli-Israel S, Poceta JS, Stepnowsky C, Martin J, Gehrman P. Identification and treatment of sleep problems in the elderly. Sleep Med Rev. 1997;1(1): Canessa N, Ferini-Strambi L. Sleep-disordered breathing and cognitive decline in older adults. JAMA. 2011;306(6): Monk TH, Buysse DJ, Billy BD, et al. Circadian type and bed-timing regularity in 654 retired seniors: correlations with subjective sleep measures. Sleep. 2011;34(2): Geib LTC, Neto AC, Wainberg R, Lahorgue MN. [Sleep and aging]. Rev Psiquiatr Rio Gd Sul. 2003;25: [Article in Portuguese] 30. Ceolim MF, Diogo MJDE, Cintra FA. [Sleep quality of older people in group health care for the elderly at the University Hospital of Campinas]. Nursing (São Paulo). 2001;4(33): [Article in Portuguese] 31. Drasdo N, Chiti Z, Owens DR, North RV. Effect of darkness on inner retinal hypoxia in diabetes. Lancet. 2002;359(9325): Cunha MC, Zanetti ML, Hass VJ. Sleep quality in type 2 diabetics. Rev Lat Am Enfermagem. 2008;16(5): Vol. 24, No. 5 May

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