Efficacy and Safety of P2Y12 monotherapy vs standard DAPT in patients undergoing percutaneous coronary intervention: meta-analysis of randomized trials.

BACKGROUND: Debates persist regarding the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Recent trials have introduced a novel approach involving P2Y12 inhibitor monotherapy with ticagrelor or clopidogrel, after a short DAPT. However, the effectiveness and safety of this strategy remains to be established. We aimed to perform a meta-analysis comparing monotherapy with P2Y12 inhibitors versus standard DAPT in patients undergoing PCI at 12 months. METHODS: Multiple databases were searched. Six RCTs with a total of 24877 patients were included. The primary endpoint was all-cause mortality at 12 months of follow-up. The secondary endpoints were cardiovascular mortality, myocardial infarction, probable or definite stent thrombosis, stroke events, and major bleeding. The study is registered with PROSPERO (CRD42024499529). RESULTS: Monotherapy with P2Y12 inhibitor ticagrelor significantly reduced both allcause mortality (HR 0.71, 95 CI [0.55-0.91], P = 0.007) and cardiovascular mortality (HR 0.66, 95% CI [0.49-0.89], P = 0.006) compared to standard DAPT. In contrast, clopidogrel monotherapy did not demonstrate a similar reduction. The decrease in mortality associated with ticagrelor was primarily due to a lower risk of major bleeding (HR 0.56, 95% CI [0.43-0.72], P < 0.001), while the risk of myocardial infarction (MI) remained unchanged (HR 0.90, 95% CI [0.73-1.11], P = 0.32). The risk of stroke was found to be similar across treatments. CONCLUSIONS: In comparison to standard DAPT, P2Y12 inhibitor monotherapy with ticagrelor may lead to a reduced mortality. The clinical benefits are driven by a reduction of bleeding risk without ischemic risk trade-off.

Effectiveness of Karate in Oncology Patients: A Quasi-Experimental Study.

Cancer is a global health concern and affects patient quality of life, anxiety, depression, and sleep. Physical exercise shows promise in alleviating these effects. Karate is a holistic intervention that could be used to improve several outcomes related to cancer disease, but to date its effect remains unexplored. This quasi-experimental pre-/poststudy evaluated the effects of a 6-month karate program conducted twice a week for 60 minutes each session on quality of life, anxiety, depression, sleep quality, and psychosomatic symptoms in 22 patients with posttherapy oncology. Significant improvements in quality of life (P = .006), anxiety (P < .001), depression (P < .001), and sleep quality (P = .011) were observed. Multidimensional psychophysical evaluation showed significant reductions in symptoms (P < .05). High participant satisfaction was reported across all dimensions. This pilot study shows the potential benefits in oncology patients, but more research is necessary to confirm these findings.

Clinical application of virtual reality in patients with cardiovascular disease: state of the art.

Virtual reality offers a multisensory experience to patients, allowing them to hear, watch, and interact in a virtual environment. Immersive virtual reality is particularly suitable for the purpose of completely isolating patients from the external environment to transport them away from the suffering related to the disease. On this state of the art, we summarize the available literature on the effectiveness of virtual reality on various physical and psychological outcomes in patients with atherosclerotic cardiovascular disease. Virtual reality has been employed in the cardiovascular field in various settings such as cardiac rehabilitation, interventional cardiology, and cardiac surgery. This technology offers promising opportunities to improve several outcomes related to cardiovascular disease, but further research is needed to entirely capture its benefits and to standardize the intervention.

Effectiveness of virtual reality on pain and anxiety in patients undergoing cardiac procedures: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cardiac procedures often induce pain and anxiety in patients, adversely impacting recovery. Pharmachological approaches have limitations, prompting exploration of innovative digital solutions like virtual reality (VR). Although early evidence suggests a potential favourable benefit with VR, it remains unclear whether the implementation of this technology can improve pain and anxiety. We aimed to assess by a systematic review and meta-analysis the effectiveness of VR in alleviating anxiety and pain on patients undergoing cardiac procedures. METHODS: Our study adhered to the PRISMA method and was registered in PROSPERO under the code CRD42024504563. The search was carried out in the PubMed, Web of Science, Scopus, and the Cochrane Library databases in January 2024. Four randomized controlled trials were included (a total of 382 patients). Risk of bias was employed to assess the quality of individual studies, and a random-effects model was utilized to examine the overall effect. RESULTS: The results showed that VR, when compared to the standard of care, had a statistically significant impact on anxiety (SMD = -0.51, 95 % CI: -0.86 to -0.16, p = 0.004), with a heterogeneity I2 = 57 %. VR did not show a significant difference in terms of pain when compared to standard care (SMD= -0.34, 95 % CI: -0.75 to -0.07, p = 0.10). The included trials exhibited small sample sizes, substantial heterogeneity, and variations in VR technology types, lengths, and frequencies. CONCLUSIONS: VR effectively lowers anxiety levels in patients undergoing cardiac procedures, however, did not show a statistically significant difference on pain.

Improving adherence to rehabilitation for heart failure patients through immersive virtual reality (VIRTUAL-HF): A protocol for a randomized controlled trial.

BACKGROUND: To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes). METHODS: A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients, according to guidelines, will perform 30-min of CR sessions with moderate intensity, twice a week for one month. RESULTS: Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. CONCLUSIONS: If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.

Effectiveness of Music to Improve Anxiety in Hemodialysis Patients: A Systematic Review and Meta-analysis.

Anxiety affects many hemodialysis patients. The response to treatment varies and often requires patients to take therapeutics for long periods; thus, many patients look for complementary approaches. There have been reports of music alleviating anxiety in hemodialysis patients. However, the efficacy of music needs to be evaluated. The objective of this study was to conduct a systematic review and meta-analysis to compare the effects of participation in standard care combined with music with standard care alone. This was a systematic review and meta-analysis of randomized controlled trials to determine the efficacy of music to lower anxiety in hemodialysis patients. Five studies were included in the review (290 patients). Listening to music resulted, on average, in an anxiety reduction that was -0.52 standard deviation units greater (95% confidence interval, -1.02 to -0.03 lower, P = .003) than in the standard care group. No adverse events were identified. All trials contained a risk of bias due to lack of blinding. The heterogeneity showed an I = 75%. The strength of evidence was very low. No adverse events were identified. Few trials were available for inclusion, with small sample sizes and significant heterogeneity. Within these considerable limitations there was a demonstrated decrease in anxiety for hemodialysis patients receiving standard care augmented with music. The effect size was moderate. Results were inconsistent across studies. We are uncertain about the estimate. The likelihood that effect will be substantially different is very high. Further research has a large potential for reducing uncertainty about the effects of the music interventions.

Narrative-Based Practice.

Narrative-based practice has been developed to bring the health care aspects of illness and treatment closer to the psychosocial and life experiences of a patient. It gives value to the lived experience by using writing tools, spoken words, poetry, drawing, and photography. Nephrology has become one of the first health care fields, likely due to its large patient burden of both critical and chronic disease, to use narrative-based practice. The use of narrative-based practice in renal care explores the lived experience through structured and semistructured interviews with patients, caregivers, and health care providers. The principle topics discussed are the lack of a "disease identity" that would allow patients to identify themselves with a specific state of illness, the "uncertainty" of living with an illness characterized by continuous progression and regression, and the living with the "unspeakable" looming specter of death. This review highlights the powerful significance of qualitative knowledge gained with the narrative method. Increased awareness of these aspects of patients' lived experiences can help nurses improve the quality and effectiveness of the therapeutic relationship between patient and health care professional and may offer a promising approach, within this relationship, to decreasing patient feelings of isolation.

Beneficial Effects of Listening to Classical Music in Patients With Heart Failure: A Randomized Controlled Trial.

BACKGROUND: Practical recommendations on nonpharmacologic non-device/surgical interventions in patients with heart failure (HF) are well known. Although complementary treatments may have beneficial effects, there is no evidence that these on their own improve mortality, morbidity, or quality of life. We examined the effects of listening to recorded classical music on HF-specific quality of life (QOL), generic QOL, sleep quality, anxiety, depression, and cognitive state in patients with HF in the home-care setting. METHODS AND RESULTS: Multicenter randomized controlled trial. One hundred fifty-nine patients with HF were randomized on a 1:1 basis in 2 groups: experimental (music) and control. Patients were evaluated after 30, 60, 90 days (experimental period) and at 6 months. Patients randomized to the music group listened to music from a large preselected playlist, at least 30 minutes per day, for 3 months on an MP3 player. Patients in the control group received standard care. HF-specific QOL, generic QOL, self-care, somatic perception of HF symptoms, sleep quality, anxiety and depression, and cognitive abilities were assessed throughout the use of specific scales. On average, patients in the music group showed greater improvements in terms of HF-specific QOL (P < .001), generic-QOL (P = .005), quality of sleep (P = .007), anxiety and depression levels (P < .001 for both), and cognitive performances (P = .003). CONCLUSIONS: Listening to recorded classical music is a feasible, noninvasive, safe, and inexpensive intervention, able to improve QOL in patients with HF in the home-care setting.

Effects of Virtual Reality in Patients Undergoing Dialysis: Study Protocol.

Dialysis is often considered slow, repetitive, and with programmed intervals. Patients often perceive it as time taken from their lives with a sense of ineluctability and emptiness, engendering a negative emotional and cognitive perception of the world and one's place in it. Today, it is possible to improve the quality of life of patients during hemodialysis using virtual reality (VR). This creation of a true multisensory experience may absorb the patient's perceptions during hemodialysis, improving his/her quality of life. An Italian multicenter, longitudinal experimental study will be conducted with a randomized, pre-post test design, with balanced allocation 1:1, in parallel groups with a control group in the standard care of patients diagnosed with chronic renal failure who are, undergoing hemodialysis treatment. A sample of 186 patients calculated with sample size (power = 80%, ß = 0.2, α = 0.05) will be randomized into an experimental group exposed to VR, and a control group in standard care. The 2 groups will be studied over a period of 1 month, with 12 applications of VR and with measurements of the following outcomes: anxiety, fatigue, pruritus, arterial pressure, heart rate, respiration rate, and duration of the session at each hemodialysis session. This is the first international experimental protocol that examines the application of VR in patients undergoing hemodialysis. If the results show statistically and clinically significant differences, the VR could be an additional holistic intervention, which is evidence based, linked to the humanization of chronic, repetitive interventions, complementary to and synergistic with standard of care.

Effects of Listening to Live Singing in Patients Undergoing Hemodialysis: A Randomized Controlled Crossover Study.

BACKGROUND: Participation in music therapy is associated with improved psychological and physical indices among chronically ill patients. Listening to music during hemodialysis treatments positively affects patients' hemodynamics, laboratory values, quality of life, and physical symptoms. The effect of live singing during hemodialysis treatments, however, has not previously been studied. METHODS: A total of 24 participants with a diagnosis of end-stage kidney disease participated in the study. The vocalist was a musically trained dialysis nurse. Twelve of the patients listened to 15 min of live singing during 6 consecutive hemodialysis sessions, while the other 12 underwent standard hemodialysis. After a washout period of 2 days, the two groups were reversed. RESULTS: Listening to live music was associated with improvements in systolic and diastolic blood pressure, better quality of sleep, fewer cramps, and reduced anxiety/depression, pain, and itching ( p < .05, all values). CONCLUSIONS: Listening to live music during hemodialysis is an effective and potentially low-cost therapy for the dialysis care team to employ during hemodialysis treatments.

A Conceptual Framework Encompassing the Psychoneuroimmunoendocrinological Influences of Listening to Music in Patients With Heart Failure.

Patients with heart failure have been traditionally treated with a pharmacology-based approach, diet, exercise, and rehabilitation for reducing symptoms, hospitalizations, and mortality. We have developed a solid conceptual framework for music listening-based protocols, showing how music may have a broad range of positive effects on cardiovascular health through psychoneuroimmunoendocrinological pathways.

Effects of live sax music on various physiological parameters, pain level, and mood level in cancer patients: a randomized controlled trial.

BACKGROUND: Few randomized controlled trial studies have focused on the effect of music in cancer patients, and there are no randomized controlled trials on the effects of live music with saxophone in cancer patients. OBJECTIVES: To determine the effects of live saxophone music on various physiological parameters, pain level, and mood level. DESIGN: A randomized controlled trial study. PARTICIPANTS: 52 cancer patients were randomized to a control group (n = 26), an experimental group (n = 26) whose members received 30 minutes of live music therapy with saxophone. MEASUREMENTS: Systolic and diastolic blood pressure, pulse rate, glycemia, oxygen saturation, pain level, and mood level were measured before and after the live music performance. RESULTS: There was a statistical difference between the groups for oxygen saturation (0.003) and mood level (0.001). CONCLUSIONS: Live music performed with a saxophone could be introduced in oncology care to improve the oxygen saturation and mood in cancer patients.

Effects of live saxophone music on physiological parameters, pain, mood and itching levels in patients undergoing haemodialysis.

BACKGROUND: Few studies have focused on the effect of music in patients undergoing haemodialysis. OBJECTIVES: To determine the effects of live saxophone music on various physiological parameters and pain, mood and itching levels. DESIGN: A randomised controlled study with 114 patients undergoing haemodialysis with a control group (n = 57) and an experimental group (n = 57) who received 30 minutes of live saxophone music therapy. MEASUREMENTS: Systolic and diastolic blood pressure, pulse rate, glycaemia, oxygen saturation, pain, mood and itching levels were measured before and after the live music performance, resulting in baseline and post-test values for the patients in the experimental group. RESULTS: The experimental group showed a statistically significant reduction in pain level, and an improvement in mood and itching levels and in the oxygen saturation. CONCLUSION: Live saxophone music could be introduced to improve clinical and quality-of-life measures in patients undergoing haemodialysis.