Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial.

OBJECTIVES: Delirium is a serious complication following neurosurgical procedures. We hypothesise that the beneficial effect of music on a combination of delirium-eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes. DESIGN: Prospective randomised controlled trial. SETTING: Single centre, conducted at the neurosurgical department of the Erasmus Medical Center, Rotterdam, the Netherlands. PARTICIPANTS: Adult patients undergoing craniotomy were eligible. INTERVENTIONS: Patients in the intervention group received preferred recorded music before, during and after the operation until day 3 after surgery. Patients in the control group were treated according to standard of clinical care. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was presence or absence of postoperative delirium within the first 5 postoperative days measured with the Delirium Observation Screening Scale (DOSS) and, in case of a daily mean score of 3 or higher, a psychiatric evaluation with the latest Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. Secondary outcomes included anxiety, heart rate variability (HRV), depth of anaesthesia, delirium severity and duration, postoperative complications, length of stay and location of discharge. RESULTS: We enrolled 189 patients (music=95, control=94) from July 2020 through September 2021. Delirium, as assessed by the DOSS, was less common in the music (n=11, 11.6%) than in the control group (n=21, 22.3%, OR:0.49, p=0.048). However, after DSM-5 confirmation, differences in delirium were not significant (4.2% vs 7.4%, OR:0.47, p=0.342). Moreover, music increased the HRV (root mean square of successive differences between normal heartbeats, p=0.012). All other secondary outcomes were not different between groups. CONCLUSION: Our results support the efficacy of music in reducing the incidence of delirium after craniotomy, as found with DOSS but not after DSM-5 confirmation, substantiated by the effect of music on preoperative autonomic tone. Delirium screening tools should be validated and the long-term implications should be evaluated after craniotomy. TRIAL REGISTRATION NUMBER: Trialregister.nl: NL8503 and ClinicalTrials.gov: NCT04649450.

Feasibility of Light and Music Therapy in the Elderly for the Prevention of Hospital-Associated Delirium.

Hospital-associated delirium is common in older adults, especially those with dementia, and is associated with high morbidity and mortality. We performed a feasibility study in the emergency department (ED) to examine the effect of light and/or music on the incidence of hospital- associated delirium. Patients aged ≥ 65 who presented to the ED and tested positive for cognitive impairment were enrolled in the study (n = 133). Patients were randomized to one of four treatment arms: music, light, music and light, and usual care. They received the intervention during their ED stay. In the control group, 7/32 patients developed delirium, while in the music-only group, 2/33 patients developed delirium (RR 0.27, 95% CI 0.06-1.23), and in the light-only group (RR 0.41, 95% CI 0.12-1.46), 3/33 patients developed delirium. In the music + light group, 8/35 patients developed delirium (RR 1.04, 95% CI 0.42--2.55). Providing music therapy and bright light therapy to ED patients was shown to be feasible. Although this small pilot study did not reach statistical significance, there was a trend towards less delirium in the music-only and light-only groups. This study lays the groundwork for future investigation into the efficacy of these interventions.

Advances in the prevention and treatment of postoperative delirium by acupuncture: A review.

Postoperative delirium is a common postoperative complication of neurocognitive dysfunction, especially in elderly surgical patients. Postoperative delirium not only damages patients' recovery but also increases social costs. Therefore, its prevention and treatment has essential clinical and social significance. However, due to its intricate pathogenesis and limited pharmacological interventions, the effective prevention and treatment of postoperative delirium remains a thorny problem. As traditional acupuncture therapy has been shown to be an effective treatment in many neurological disorders, and in recent years, it has begun to be clinically used as an intervention for postoperative delirium. Although most clinical and animal studies confirm that multiple types of acupuncture interventions can alleviate or prevent postoperative delirium by relieving acute postoperative pain, reducing the consumption of anesthetics and analgesics, attenuating neuroinflammation and neuronal lesions, while more evidence-based medical evidence and clinical validation are needed for these encouraging effects.

Transcutaneous electrical acupoint stimulation combined with an integrated perioperative nursing program prevents subsyndromal delirium in older patients after joint replacement.

OBJECTIVES: This study aimed to develop transcutaneous electrical acupoint stimulation combined with an integrated perioperative nursing program and evaluate its effects on preventing subsyndromal delirium (SSD) and postoperative delirium (POD) in older patients after joint replacement surgery. METHODS: Participants were randomly divided into two groups, the experimental group (n = 48) was given transcutaneous electrical acupoint stimulation combined with an integrated perioperative nursing program based on the routine care of the control group (n = 49). The incidence of SSD and POD in a week after surgery was recorded. Assessments of delirium severity, cognition, anxiety, and depression were also conducted at baseline and on postoperative day 7. RESULTS: The findings indicate that the intervention program had significant advances in alleviating the severity of delirium, cognitive impairment, anxiety, and depression but failed to reduce the incidence of SSD and POD. CONCLUSIONS: Our study indicated that TEAS combined with an integrated perioperative nursing program has a beneficial effect on alleviating symptoms of delirium, cognitive dysfunction, anxiety, and depression in older adults after joint replacement surgery.

Effects of nonpharmacological interventions on sleep improvement and delirium prevention in critically ill patients: A systematic review and meta-analysis.

OBJECTIVE: Sleep disturbance and delirium are common problems experienced by critically ill patients in the intensive care unit (ICU). These interrelated issues increase the length of stay in the ICU but might also negatively affect long-term health outcomes. The objective of this study was to identify the nonpharmacological interventions provided to improve sleep or prevent delirium in ICU patients or both and integrate their effect sizes. REVIEW METHODS: This study was a registered systematic review and meta-analysis. We searched MEDLINE, CINAHL, EMBASE, Web of Science, and Cochrane Library from their inception until December 2021. We included randomised controlled trials and nonrandomised controlled trials-(RCT) that provided nonpharmacological interventions and reported sleep or delirium as outcome variables. Studies not published in English or whose full text was not available were excluded. The quality of the evidence was assessed with version 2 of the Cochrane risk-of-bias tool for RCTs and the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I). RESULTS: The systematic review included 118 studies, and the meta-analysis included 100 studies. Overall nonpharmacological interventions had significant effects on subjective sleep quality (standardised mean difference = 0.30, 95% confidence interval [CI] = 0.05 to 0.56), delirium incidence (odds ratio = 0.62, 95% CI = 0.53 to 0.73), and delirium duration (standardised mean difference = -0.68, 95% CI = -0.93 to -0.43). In individual interventions, aromatherapy, music, and massage effectively improved sleep. Exercise, family participation, information giving, cognitive stimulation, bright light therapy, architectural intervention, and bundles/protocols effectively reduced delirium. Light/noise blocking was the only intervention that ensured both sleep improvement and delirium prevention. CONCLUSIONS: Our results suggest nonpharmacological interventions improve sleep and prevent delirium in ICU patients. We recommend that ICU nurses use nonpharmacological interventions that promote person-environment compatibility in their clinical practice. The results of our review can guide nurses in adopting interventions related to sleep and delirium. PROSPERO REFERENCE NUMBER: CRD42021230815.

PAINT I: the effect of art therapy in preventing and managing delirium among hospitalized older adults in the PAINT I study-a proof-of-concept trial.

BACKGROUND: Delirium is common among older hospitalized patients and is regarded as a negative outcome parameter. Non-pharmacological strategies have been shown to be effective in the prevention and management of delirium. This study aimed to determine the effectiveness of art therapy as part of a multicomponent intervention in preventing and managing delirium in hospitalized older patients. METHODS: 138 patients at risk of developing delirium were included and received art therapy twice daily for 25 min using a mobile atelier. 107 participants were included in the final analysis (N = 53 intervention, N = 54 control). The primary outcome was the effectiveness of art therapy in preventing delirium. The secondary outcome was to determine its impact on duration of delirium in patients with existing delirium. Delirium was assessed using the Nursing delirium Screening Scale (Nu-DESC). RESULTS: 8 patients (7.5%) developed new onset delirium after admission, equally distributed among control and intervention group. Therefore, no valid statistical analysis could be performed. There was a statistically non-significant decrease in the duration of delirium in the intervention group (4 days, IQR 2.25-8.75) compared to the control group (7 days, IQR 5-10), Mann-Whitney-U-Test p-value = 0.26. After stratifying by dementia diagnosis on admission, the non-significant decrease in duration of delirium in the intervention group was more apparent in patients without dementia. CONCLUSION: Findings from this study showed that the integration of art therapy as part of a multicomponent intervention in delirium management is feasible, and can reduce duration of delirium among hospitalized older adults.

The effect of taurine supplementation on delirium post liver transplantation: A randomized controlled trial.

BACKGROUND & AIMS: Delirium is a prevalent complication of liver transplantation (LT). It may enhance the risk of morbidity and mortality. Taurine is considered to have antioxidant and neuroprotective activities. The aim of this study was to evaluate taurine supplementation effect on post-LT delirium. METHODS: Patients older than 18 years old who had received LT in Abu-Ali Sina transplantation center in Shiraz, Iran from September 2020 to June 2021, were enrolled in this double-blinded randomized clinical trial. Exclusion criteria was known hypersensitivity to taurine, pregnancy or breast-feeding and death within 72 h post-LT. Patients were randomly divided into two groups, each received 2 g/day placebo or taurine from the first day post-LT for 30 days. Delirium was assessed using Confusion Assessment Method-Intensive Care Unit (CAM-ICU). Mortality and rejection rates and length of Intensive Transplantation Unit (ITU) and hospital stays were evaluated within one month after transplantation. RESULTS: Two hundred and seven patients were divided into two groups. Twenty-eight and 23 patients were excluded due to their refuse to participate in the study and death within 72 h post-LT, respectively. Delirium rate within the first month was 23.08% and was significantly lower in taurine group (9.46%) compared with placebo (35.36%, P = 0.012). Length of ITU stay was significantly higher among delirious patients (P = 0.015) in this analysis. CONCLUSION: we reached to the result that taurine can prevent post-LT delirium, dramatically. Placebo receiving and longer stay in ITU were the only independent risk factors in this trial. REGISTRATION NUMBER OF CLINICAL TRIAL: The study was registered at the Iranian Registry of Clinical Trials (IRCT20200312046755N1; http://www.irct.ir/).

Prevention of delirium with agitation by yokukansan in older adults after cancer surgery.

OBJECTIVE: Preventing postoperative delirium with agitation is vital in the older population. We examined the preventive effect of yokukansan on postoperative delirium with agitation in older adult patients undergoing highly invasive cancer resection. METHODS: We performed a secondary per-protocol analysis of 149 patients' data from a previous clinical trial. Patients underwent scheduled yokukansan or placebo intervention 4-8 days presurgery and delirium assessment postoperatively. Delirium with agitation in patients aged ≥75 years was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and the Japanese version of the Delirium Rating Scale-Revised-98. We assessed odds ratios for yokukansan (TJ-54) compared with placebo for the manifestation of postoperative delirium with agitation across patients of all ages (n = 149) and those aged ≥65 years (n = 82) and ≥ 75 years (n = 21) using logistic regression. RESULTS: Delirium with agitation manifested in 3/14 and 5/7 patients in the TJ-54 and placebo groups, respectively, among those aged ≥75 years. The odds ratio for yokukansan vs. placebo was 0.11 (95% confidence interval: 0.01-0.87). An age and TJ-54 interaction effect was detected in patients with delirium with agitation. No intergroup differences were observed in patients aged ≥65 years or across all ages for delirium with agitation. CONCLUSIONS: This is the first study investigating the preventive effect of yokukansan on postoperative delirium with agitation in older adults. Yokukansan may alleviate workforce burdens in older adults caused by postoperative delirium with agitation following highly invasive cancer resection.

Early Intervention of Perioperative Delirium in Older Patients (>60 years) with Hip Fracture: A Randomized Controlled Study.

OBJECTIVE: To explore the effect of early intervention for perioperative delirium in older (> 60 years) hip fracture patients. METHODS: This prospective study enrolled hip fracture patients aged ≥60 years who were admitted into our hospital between July 2011 and August 2019. Hip fractures were classified according to the Arbeitsgemeinschaft für Osteo-synthesefragen (AO) classification. This study included patients with isolated hip fracture and excluded patients with pathological or peri prosthetic fracture or patients with multiple traumatic injuries and high-energy trauma. They were randomized to receive conventional orthopedic care group (n = 65) or comprehensive orthopedic care group including preoperative psychological counseling and preventative risperidone (n = 63). Daily assessment was based on patient interview with the CAM-CR, and delirium was diagnosed by the Delirium Rating Scale (DRS-R-98). The rate, severity and duration of perioperative delirium and the length of postoperative stay were analyzed. RESULTS: Totally 200 patients were screened for eligibility. Twenty patients were excluded due to alcohol abuse and 40 were excluded because of brain lesions on head CT. In addition, 12 patients were excluded because of impaired cognition. Finally 128 patients were enrolled. Their mean age was 75.3 ± 2.2 years for the comprehensive orthopedic care group and 73.5 ± 6.1 years for the conventional orthopedic care group, and 53.9% of the patients were female. Sixty-eight (53.1%) patients had intertrochanteric fracture, 39.8% patients had femoral head fracture, and 7.0% patients had subtrochanteric fracture. In addition, 58.6% patients underwent internal fixation and 41.4% patients received arthroplasty. In this study, 63 patients were randomized to the comprehensive orthopedic care group and 65 patients to the conventional orthopedic care group. The two groups were comparable in demographic and baseline characteristics (P > 0.05). The rate of perioperative delirium was significantly lower in the comprehensive care group vs the conventional care group (15.9% vs. 30.8%; P < 0.05). The comprehensive care group had significantly reduced length of postoperative hospital stay vs the conventional care group (11.3 ± 2.5 days vs. 14.2 ± 2.2 days, P < 0.01). The mean DRS-R-98 score was 7.1 ± 2.7 for the comprehensive care group, and was significantly lower than that of the conventional orthopedic care group (11.2 ± 3.0; P < 0.05). CONCLUSIONS: Our early intervention may reduce the incidence of perioperative delirium in elderly hip fracture patients (>60 years).

2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility.

RATIONALE: A guideline that both evaluates current practice and provides recommendations to address sedation, pain, and delirium management with regard for neuromuscular blockade and withdrawal is not currently available. OBJECTIVE: To develop comprehensive clinical practice guidelines for critically ill infants and children, with specific attention to seven domains of care including pain, sedation/agitation, iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment, and early mobility. DESIGN: The Society of Critical Care Medicine Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility Guideline Taskforce was comprised of 29 national experts who collaborated from 2009 to 2021 via teleconference and/or e-mail at least monthly for planning, literature review, and guideline development, revision, and approval. The full taskforce gathered annually in-person during the Society of Critical Care Medicine Congress for progress reports and further strategizing with the final face-to-face meeting occurring in February 2020. Throughout this process, the Society of Critical Care Medicine standard operating procedures Manual for Guidelines development was adhered to. METHODS: Taskforce content experts separated into subgroups addressing pain/analgesia, sedation, tolerance/iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment (family presence and sleep hygiene), and early mobility. Subgroups created descriptive and actionable Population, Intervention, Comparison, and Outcome questions. An experienced medical information specialist developed search strategies to identify relevant literature between January 1990 and January 2020. Subgroups reviewed literature, determined quality of evidence, and formulated recommendations classified as "strong" with "we recommend" or "conditional" with "we suggest." Good practice statements were used when indirect evidence supported benefit with no or minimal risk. Evidence gaps were noted. Initial recommendations were reviewed by each subgroup and revised as deemed necessary prior to being disseminated for voting by the full taskforce. Individuals who had an overt or potential conflict of interest abstained from relevant votes. Expert opinion alone was not used in substitution for a lack of evidence. RESULTS: The Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility taskforce issued 44 recommendations (14 strong and 30 conditional) and five good practice statements. CONCLUSIONS: The current guidelines represent a comprehensive list of practical clinical recommendations for the assessment, prevention, and management of key aspects for the comprehensive critical care of infants and children. Main areas of focus included 1) need for the routine monitoring of pain, agitation, withdrawal, and delirium using validated tools, 2) enhanced use of protocolized sedation and analgesia, and 3) recognition of the importance of nonpharmacologic interventions for enhancing patient comfort and comprehensive care provision.

Regional anesthesia techniques and postoperative delirium: systematic review and meta-analysis.

INTRODUCTION: Postoperative delirium is a frequent occurrence in the elderly surgical population. As a comprehensive list of predictive factors remains unknown, an opioid-sparing approach incorporating regional anesthesia techniques has been suggested to decrease its incidence. Due to the lack of conclusive evidence on the topic, we conducted a systematic review and meta-analysis to investigate the potential impact of regional anesthesia and analgesia on postoperative delirium. EVIDENCE ACQUISITION: PubMed, Embase, and the Cochrane central register of Controlled trials (CENTRAL) databases were searched for randomized trials comparing regional anesthesia or analgesia to systemic treatments in patients having any type of surgery. This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We pooled the results separately for each of these two applications by random effects modelling. Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the certainty of evidence and strength of conclusions. EVIDENCE SYNTHESIS: Eighteen trials (3361 subjects) were included. Using regional techniques for surgical anesthesia failed to reduce the risk of postoperative delirium, with a relative risk (RR) of 1.21 (95% CI: 0.79 to 1.85); P=0.3800. In contrast, regional analgesia reduced the relative risk of perioperative delirium by a RR of 0.53 (95% CI: 0.42 to 0.68; P<0.0001), when compared to systemic analgesia. Post-hoc subgroup analysis for hip fracture surgery yielded similar findings. CONCLUSIONS: These results show that postoperative delirium may be decreased when regional techniques are used in the postoperative period as an analgesic strategy. Intraoperative regional anesthesia alone may not decrease postoperative delirium since there are other factors that may influence this outcome.

[Light Therapy for Prevention of Delirium in Critically Ill Patients: What's the Evidence?] / Lichttherapie zur Delirprävention bei Intensivpatienten: Was sagt die Evidenz?

Circadian dysrhythmia affects the majority of ICU patients and has far-reaching effects on organ functioning. At the level of the central nervous system, circadian misalignment facilitates executive cognitive dysfunction and the development of ICU delirium. The pathophysiological mechanisms, especially in the cohort of critically ill patients, appear to be complex, multilayered and far from understood. Results from preliminary research indicate that multidimensional, patient-specific chronotherapeutic concepts developed specifically for the ICU setting may help improve the healing process of patients. Circadian lighting therapy might be a promising intervention in this context.

A framework of social determinants of health for delirium tailored to older adults.

Delirium is a debilitating medical condition that disproportionately affects hospitalized older adults and is associated with adverse health outcomes, increased mortality, and high medical costs. Efforts to understand delirium risk in hospitalized older adults have focused on examining medical comorbidities, pre-existing cognitive deficits, and other clinical and demographic factors present in the period proximate to the hospitalization. The contribution of social determinants of health (SDOH), including social circumstances, environmental characteristics, and early-life exposures, referred as the social exposome, to delirium risk is poorly understood. Increased knowledge about the influence of SDOH will offer a more comprehensive understanding of factors that may increase vulnerability to delirium and poor outcomes. Clinically, these efforts can guide the development and implementation of holistic preventive strategies to improve clinical outcomes. We propose a SDOH framework for delirium adapted for older adults. We provide the definition, description, and rationale for the domains and variables in our proposed model.

Delirium in Critical Illness Patients and the Potential Role of Thiamine Therapy in Prevention and Treatment: Findings from a Scoping Review with Implications for Evidence-Based Practice.

INTRODUCTION: Thiamine is a water-soluble vitamin and is necessary for energy metabolism. Critically ill patients are at particular risk of developing thiamine deficiency and related complications. One of the complications that can occur is delirium. Delirium is a disorder that affects the body's response to treatment, length of stay in the ward, mortality, long-term cognitive impairment, and significantly increases treatment costs. In addition, studies show that delirium medication is more effective in preventing than in treating delirium. Given its low cost, availability, and minimal risk of side effects, thiamine supplementation could prove to be a relevant strategy in the prevention and treatment of delirium. METHODS: PubMed, Cochrane Library, Ovid, and ClinicalTrials.gov databases were searched using relevant keywords that focus on the use of thiamine to prevent or treat delirium in critically ill patients. RESULTS: Seven articles were included in the analysis. CONCLUSION: The small number of studies and considerable heterogeneity prevent conclusions supporting the use of thiamine as an adjuvant in the prevention and treatment of delirium among critically ill patients. There is a need for high-quality, large-scale randomized clinical trials to confirm the beneficial effects of thiamine in the prevention and treatment of delirium.

A randomized double-blind placebo-controlled trial of intravenous thiamine for prevention of delirium following allogeneic hematopoietic stem cell transplantation.

OBJECTIVE: To determine if high dose intravenous (IV) thiamine can prevent delirium during hospitalization following allogeneic HSCT. Secondarily, we evaluated the effects of high dose IV thiamine on thiamine levels and explored risk factors for delirium. METHODS: Randomized, double-blind, placebo-controlled trial in patients undergoing allogeneic HSCT at a U.S. academic medical center between October 2017 and March 2020. 64 participants were randomized 1:1 to thiamine 200 mg IV three times daily for 7 days or placebo. We used the Delirium Rating Scale to assess for delirium. Delirium incidence was compared between groups using the chi-square test. Group differences in time to onset and duration of delirium were compared using the Kaplan-Meier method. Fisher's Exact and Wilcoxon Rank Sum tests were used to examine associations between pre-transplantation variables and delirium. RESULTS: 61 participants were analyzed. Delirium incidence (25% vs. 21%, Chi-square (df = 1) = 0.12, p = 0.73), time to onset, duration, and severity were not different between study arms. Immediately following the intervention, thiamine levels were higher in the thiamine arm (275 vs. 73 nmol/L, t-test (df = 57) = 13.63, p < 0.0001), but not predictive of delirium. Variables associated with delirium in our sample included disease severity, corticosteroid exposure, infection, and pre-transplantation markers of nutrition. CONCLUSION: High dose IV thiamine did not prevent delirium in patients receiving allogeneic HSCT. Given the multiple contributors to delirium in this population, further research regarding the efficacy of multicomponent interventions may be needed. TRIAL REGISTRATION: Clinical Trials NCT03263442. FUNDING: Rising Tide Foundation for Clinical Cancer Research.

A randomized, controlled, multicenter clinical study of the "improved sitting Wuqinxi" intervention for mechanically ventilated patients in the intensive care unit.

INTRODUCTION: Mechanical ventilation is a powerful tool for the treatment of various critical emergencies. However, surviving critically ill patients often have poor psychological and physiological outcomes. Prevention of various complications and adverse outcomes of mechanical ventilation is a priority and a challenge in the intensive care unit (ICU). Early intervention is the key to reducing complications and improving outcomes of mechanical ventilation in the ICU. As an auxiliary rehabilitation treatment, the improved sitting Wuqinxi intervention has recognized unique advantages. It has achieved beneficial therapeutic effects during early intervention in clinical practice. It can reduce the incidence of delirium, shorten the duration of mechanical ventilation, and prevent complications and secondary damages related to mechanical ventilation in the ICU. Therefore, the purpose of this study will be to explore the effect of improved sitting Wuqinxi on the clinical outcomes of mechanically ventilated ICU patients. METHODS: This prospective, multicenter, randomized, single-blinded, parallel controlled clinical study will involve 160 patients who met the inclusion criteria. The patients will be randomly divided into the experimental and control groups. Both groups will be given standardized comprehensive western medicine treatment (including mechanical ventilation) and routine care in the ICU. Management of the experimental group will also include "improved sitting Wuqinxi," with the treatment objective to observe the effect of the improved sitting Wuqinxi intervention on the clinical outcomes in mechanically ventilated ICU patients. The outcome measures will include the incidence of complications, duration of mechanical ventilation, length of ICU stay, and cost of hospitalization. In addition, the effect of the improved sitting Wuqinxi intervention on the safety indexes of mechanically ventilated ICU patients will be assessed and the clinical effects of the improved sitting Wuqinxi intervention will be comprehensively evaluated. DISCUSSION: The purpose of this study will be to evaluate the effect of the improved sitting Wuqinxi intervention on the incidence of complications, duration of mechanical ventilation, length of ICU stay, cost of hospitalization, and safety indicators. If successful, it will provide a reliable, simple, and feasible auxiliary rehabilitation treatment scheme for mechanically ventilated ICU patients.

Does implementation of a tailored intervention increase adherence to a National Safety and Quality Standard? A study to improve delirium care.

BACKGROUND: Delirium is commonly detected in older people after hip fracture. Delirium is considered to be a multifactorial disorder that is often seen post-operatively (incidence ranging from 35% to 65%). Hospitals in Australia are required to meet eight standards including the comprehensive care standard to be able to maintain their accreditation. The standard includes actions related to falls, pressure injuries, nutrition, mental health, cognitive impairment and end-of-life care. Delirium prevention was identified as an area for improvement in our Orthopaedic unit in a Level 1 University Trauma Centre in Australia. This implementation research project aimed to understand the efficacy of a delirium prevention intervention within an existing orthopaedic speciality care system. OBJECTIVE: Implementation of the tailored intervention will increase adherence to National Safety and Quality Health Service Standards, thereby reducing rate of delirium. METHODS: In this study, we used an interrupted time series design to examine changes in practice over time in people admitted to hospital with a hip fracture. Clinical staff caring for patients with hip fracture in an acute care setting in Adelaide, South Australia, participated in the project. In brief, intervention included education, environmental restructuring, change champions, infographics and audit feedback reports. The primary outcome of interest was rate of delirium. The secondary outcome was compliance with the use of delirium 4AT screening tool, duration of delirium and hospital length of stay. RESULTS: The rate of change per month in patients with delirium decreased significantly by 19.2%. There was no significant change observed in trend for duration of delirium and length of hospital stay between pre-intervention and post-intervention phases. A significant increase in the use of screening tool was observed from 4.7% in the pre-intervention phase to 33.6% in the post-intervention phase. CONCLUSION: Translation of evidence-based intervention model incorporating well-considered implementation strategies had a mixed impact on decreasing the rate of delirium. The scheduled hospital accreditation enhanced the use of validated screening tool to recognize delirium. This project highlights the importance of aligning implementation goals with the wider goals of the organization as well as making clinicians accountable by consistent auditing.

Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC): a randomised controlled trial.

RATIONALE: Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sleep is important in the prevention and management of delirium. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle. It is possible that melatonin supplementation in intensive care improves sleep and prevents delirium. METHODS AND DESIGN: The 'Prophylactic Melatonin for Delirium in Intensive Care' study is a multi-centre, randomised, double-blinded, placebo-controlled trial. The primary objective of this study is to determine whether melatonin given prophylactically decreases delirium in critically ill patients. A total of 850 ICU patients have been randomised (1:1) to receive either melatonin or a placebo. Participants were monitored twice daily for symptoms of delirium. RESULTS: This paper and the attached additional files describe the statistical analysis plan (SAP) for the trial. The SAP has been developed and submitted for publication before the database has been locked and before the treatment allocation has been unblinded. The SAP contains details of analyses to be undertaken, which will be reported in the primary and secondary publications. DISCUSSION: The SAP details the analyses that will be done to avoid bias coming from knowledge of the results in advance. This trial will determine whether prophylactic melatonin administered to intensive care unit patients helps decrease the rate and the severity of delirium. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ANZCTR) ACTRN1261600043647 , registration date: 06 April 2016. WHO Trial Number - U1111-1175-1814.

Yokukansan for Treatment of Preoperative Anxiety and Prevention of Postoperative Delirium in Cancer Patients Undergoing Highly Invasive Surgery. J-SUPPORT 1605 (ProD Study): A Randomized, Double-Blind, Placebo-Controlled Trial.

CONTEXT: No standard preventive or therapeutic methods have been established for preoperative anxiety and postoperative delirium in patients with cancer. OBJECTIVES: To clarify the therapeutic effect of yokukansan for perioperative psychiatric symptoms in patients with cancer as well as to confirm its safety profile. METHODS: This is a randomized, double-blind, and placebo-controlled trial conducted at a single center in Tokyo, Japan. About 195 patients with cancer scheduled to undergo tumor resection took one packet of the study drug, which was administered orally. Coprimary outcomes were change in preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Interim analysis was performed with one-third (n = 74) of the target number of registered patients. RESULTS: Because this trial was canceled based on the results of the interim analysis and the protocol treatment was discontinued in patients who were already registered, conclusions were based on the full analysis set of 160 participants. There were no significant differences between groups in the change of mean Hospital Anxiety and Depression Scale-Anxiety score (intervention group [SD] 0.4 [3.0] vs. placebo group 0.5 [3.0]; P = 0.796) or the incidence of postoperative delirium (32% vs. 30%; P = 0.798). There were no serious adverse events in either group. CONCLUSION: In patients with cancer undergoing highly invasive surgeries, yokukansan demonstrated no significant efficacy for the treatment of preoperative anxiety or the prevention of postoperative delirium. Yokukansan is already used in daily practice in Japan, but we should be careful with its future use.

[Experience of Implementing ABCDEF Bundle Care to Reduce Delirium in a Traumatic Brain Injury Patient].

Patients with traumatic brain injury (TBI) have a high incidence rate of delirium, which leads to poor prognoses. This case study describes a nursing experience of implementing ABCDEF bundle care to reduce delirium in a patient with TBI. The period of nursing care was April 23 to April 30, 2019. A comprehensive assessment of this patient's physical, psychological, familial, social, and spiritual dimensions was conducted via consultation, observation, and physical assessment. The assessment results showed that the patient suffered from acute delirium and cerebral perfusion impairment. In addition, the results showed that the patient's wife suffered from caregiver role strain that was further exacerbated by family difficulties. Multiple, individualized patient-tailored nursing interventions were developed under ABCDEF bundle care to alleviate delirium during the period of nursing care. These interventions included spontaneous awakening trials, spontaneous breathing trials, coordination, delirium assessment, early mobilization, and family engagement. Furthermore, family involvement and interprofessional cooperation with social workers were conducted concurrently to alleviate economic and care burdens and mitigate caregiver role strain in the patient's wife. It is hoped that this nursing care experience helps promote increased attention towards delirium, helps improve early detection of delirium in patients with TBI, and promotes the provision of individualized bundle care that draws on different perspectives in order to achieve holistic health care.