Abstract:
BACKGROUND:Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium. METHODS/DESIGN:The Decreasing Delirium through Music (DDM) study is a three-arm, single-blind, randomized controlled feasibility trial. Sixty patients admitted to the ICU with respiratory failure requiring mechanical ventilation will be randomized to one of three arms (20 participants per arm): (1) personalized music, (2) non-personalized relaxing music, or (3) attention-control. Music preferences will be obtained from all enrolled participants or their family caregivers. Participants will receive two 1-h audio sessions a day through noise-cancelling headphones and mp3 players. Our primary aim is to determine the feasibility of the trial design (recruitment, adherence, participant retention, design and delivery of the music intervention). Our secondary aim is to estimate the potential effect size of patient-preferred music listening in reducing delirium, as measured by the Confusion Assessment Method for the ICU (CAM-ICU). Participants will receive twice daily assessments for level of sedation and presence of delirium. Enrolled participants will be followed in the hospital until death, discharge, or up to 28 days, and seen in the Critical Care Recovery Clinic at 90 days. DISCUSSION:DDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity. TRIAL REGISTRATION:ClinicalTrials.gov, Identifier: NCT03095443 . Registered on 23 March 2017.
journal_name
Trialsjournal_title
Trialsauthors
Khan SH,Wang S,Harrawood A,Martinez S,Heiderscheit A,Chlan L,Perkins AJ,Tu W,Boustani M,Khan Bdoi
10.1186/s13063-017-2324-6subject
Has Abstractpub_date
2017-11-29 00:00:00pages
574issue
1issn
1745-6215pii
10.1186/s13063-017-2324-6journal_volume
18pub_type
杂志文章,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-224
更新日期:2012-11-23 00:00:00
abstract:BACKGROUND:Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatmen...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-351
更新日期:2014-09-06 00:00:00
abstract:BACKGROUND:Neurofeedback has been applied effectively in various areas, especially in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). This study protocol is designed to investigate the effect of slow cortical potential (SCP) feedback and a new form of neurofeedback using near-infrared sp...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0683-4
更新日期:2015-04-18 00:00:00
abstract:BACKGROUND:During the last decade, the use of ministernotomy in cardiac surgery has increased. Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomised trials. The aim of the study is to determine if this minimally invasive approach improves qu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2486-x
更新日期:2018-02-17 00:00:00
abstract:BACKGROUND:Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2241-8
更新日期:2017-10-27 00:00:00
abstract:BACKGROUND:Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduced systemic steroid exposure ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4077-x
更新日期:2020-02-03 00:00:00
abstract:BACKGROUND:Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, but an overview of this research area is lacking. We aimed to systematically map the characteristics ...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/s13063-020-04358-3
更新日期:2020-06-05 00:00:00
abstract:BACKGROUND:In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increas...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0622-4
更新日期:2015-03-22 00:00:00
abstract:BACKGROUND:The Swiss health ministry launched a national quality program 'QualiCCare' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ('QualiCCare') improves adherence to recommended clinical processes and shows impact on p...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-96
更新日期:2014-03-27 00:00:00
abstract:BACKGROUND:Haemostasis in liver surgery remains a challenge despite improved resection techniques. Oozing from blood vessels too small to be ligated necessitate a treatment with haemostats in order to prevent complications attributed to bleeding. There is good evidence from randomised trials for the efficacy of fibrin ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-11-109
更新日期:2010-11-19 00:00:00
abstract:BACKGROUND:Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-122
更新日期:2010-12-20 00:00:00
abstract:BACKGROUND:The increasing prevalence of Alzheimer's disease and other forms of dementia raises new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Therefore, we aim to evaluate a tailored intervention to help healthcare pro...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2697-1
更新日期:2018-06-25 00:00:00
abstract:BACKGROUND:Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-3087-4
更新日期:2019-01-14 00:00:00
abstract:BACKGROUND:Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-116
更新日期:2013-04-30 00:00:00
abstract:BACKGROUND:Systematic use of observational pain tools has been advocated as a means to improve pain management for care home residents with dementia. Pain experts suggest that any observational tool should be used as part of a comprehensive pain management protocol, which should include score interpretation and verific...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-78
更新日期:2014-03-13 00:00:00
abstract:UNLABELLED:Screening physical activity levels is common in trials to increase physical activity in inactive populations. Commonly applied single-item screening tools might not always be effective in identifying those who are inactive. We applied the more extensive Active Australia Survey to identify inactive people amo...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0976-7
更新日期:2015-10-08 00:00:00
abstract:BACKGROUND:The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1443-9
更新日期:2016-07-26 00:00:00
abstract:INTRODUCTION:Sample size calculations require assumptions regarding treatment response and variability. Incorrect assumptions can result in under- or overpowered trials, posing ethical concerns. Sample size re-estimation (SSR) methods investigate the validity of these assumptions and increase the sample size if necessa...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04931-w
更新日期:2020-12-04 00:00:00
abstract:BACKGROUND:The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomis...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2518-6
更新日期:2018-03-22 00:00:00
abstract:BACKGROUND:National obesity rates have dramatically risen over the last decade. Being obese significantly reduces life expectancy, increases the risk of a range of diseases, and compromises quality of life. Costs to both the National Health Service and society are high. An increased prevalence of obesity in people with...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-71
更新日期:2013-03-12 00:00:00
abstract:BACKGROUND:Acupuncture has been widely applied in the clinic to treat irritable bowel syndrome (IBS), but the underlying mechanism remains unknown. Diffuse noxious inhibitory control (DNIC) is deficient in patients with IBS, which attenuates the systemic analgesic effect elicited by noxious stimulation that is remote f...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2948-1
更新日期:2018-10-16 00:00:00
abstract:BACKGROUND:Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. METHODS:This proof-of-concept, prospective, randomized controlled...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04385-0
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:Upper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation. The clinical efficacy of acupuncture for the recovery of post-stroke upper limb function has been previously demonstrated. Mirror therapy (MT) has also been found to be effective. However, the effects...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2585-8
更新日期:2018-05-31 00:00:00
abstract:BACKGROUND:The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the ef...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1770-x
更新日期:2017-01-19 00:00:00
abstract:BACKGROUND:Children in low and middle-income countries (LMICs) are at risk for problems in their cognitive, social and behavioural development. Factors such as a lack of cognitive stimulation, harsh parenting practices, and severe and persistent aggression in early childhood are central to the genesis of these problems...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1790-1
更新日期:2017-03-09 00:00:00
abstract:BACKGROUND:Sub-threshold depression is common, impairs functioning, and increases the risk of developing major depression. Although psychological treatments have been investigated for sub-threshold depression, they are costly. A less costly alternative could be an educational health promotion campaign about effective s...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-11
更新日期:2011-01-13 00:00:00
abstract:BACKGROUND:Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. Th...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2413-6
更新日期:2018-01-19 00:00:00
abstract:BACKGROUND:Despite long-standing problems in decisions to stop clinical trials, stopping guidelines are often vague or unspecified in the trial protocol. Clear, well-conceived guidelines are especially important to assist the data monitoring committees for effectiveness trials. MAIN TEXT:To specify better stopping gui...
journal_title:Trials
pub_type: 社论
doi:10.1186/s13063-016-1367-4
更新日期:2016-05-10 00:00:00
abstract:BACKGROUND:Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia. METHODS/DE...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-14
更新日期:2012-02-07 00:00:00
abstract:BACKGROUND:Depressive and anxiety disorders are common in general practice but not always treated adequately. Introducing stepped care might improve this. In this randomized trial we examined the effectiveness of such a stepped care model. METHODS:The study population consisted of primary care attendees aged 18-65 yea...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-171
更新日期:2011-07-07 00:00:00