ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31138 results sorted by trial registration date.
  • The Developmental and Social Benefits of a Classical/Contemporary AllPlay Dance Program for Children with Autism Spectrum Disorder

    Dance is a unique form of physical activity that involves complex movement, emotional expression, and social opportunities. While many avenues of research have suggested that dance offers a wide range of benefits to its participants, children with ASD often face barriers to participating in dance and have fewer opportunities to take part in recreational programs compared to their typically-developing peers. As a consequence, few studies have been able to assess the effects of participating in dance for these individuals and it remains unclear whether this unique activity offers any significant benefits to social, cognitive, emotional/behavioural and motor functioning. The current study aims to deliver a tailored classical/contemporary dance program to children with ASD to begin exploring the potential outcomes of participation. The primary aim will be to determine the feasibility and acceptability of the classical/contemporary AllPlay Dance program. We hypothesise that the program will be feasible, and acceptable to children with ASD, their parents, and the experienced dancers/ buddies acting in a supportive role. Data for this analysis will be collected from all participants within 8 weeks of completing the program. We will also explore the effect of the classical/contemporary AllPlay dance program on social, cognitive, emotional/behavioural and motor functioning for children with ASD. Data for these analyses will be collected from all ASD families regardless of group allocation within 8 weeks of the intervention group commencing (baseline) and completing (primary timepoint 1) the dance program.

  • Are we giving appropriate dose of tranexamic acid in hip replacement surgery?

    According to the annual report from national joint replacement registry, around 32000 primary total hip replacements (THR) have been performed in 2017 in Australia. Reported prevalence of blood transfusion in THR is around 24%. Blood transfusions are associated with infectious risk and complications such as acute lung injury, and acute or delayed immune responses. Tranexamic acid (TXA) has been widely used for its anti- fibrinolytic effect in major joint replacement surgery. It has been shown to prevent excess bleeding and reduce the risk of blood transfusion following lower limb joint replacements. Current dosing of TXA for joint replacement surgery is not based on rigorous scientific evidence and dosing based on bleeding endpoints may be sub-optimal. In this study, we propose investigating the use of biomarkers to describe the extent of fibrinolysis as dosing endpoints for the physiological effect of TXA. From this, we will provide recommendations for effective dosing regimens of TXA in patients undergoing THR.

  • Clonidine at Low dosage postOperatively to Nocturnally Enhance Sleep

    Postoperative delirium is a common surgical complication associated with major long-term morbidity and mortality. No single pharmacological agent has been conclusively shown to reduce or prevent postoperative delirium, but recent trials with dexmedetomidine – a highly selective alpha2- adrenoreceptor agonist – have been promising. A low-dose infusion on the night of surgery appears to have a lasting effect at reducing delirium for the week post infusion, and improved both the quantity and quality of sleep. If these findings could be replicated with clonidine (the prototypical alpha2-adrenoreceptor agonist), this – and subsequent – studies could have substantial implications for future perioperative delirium risk management.

  • The effect of a milk-based oral rinse on satiety

    Acute exposure to fatty acid in the oral cavity leads to a satiety response (both hormonal and behavioural) in rodent models. However, this has never been shown in human studies. In addition, there is a large variation in taste sensitivity to fatty acid among humans. Therefore, it is possible that variation in fatty acid taste sensitivity might influence the efficacy of a fatty acid-mediated satiety response. The primary aim of this study was to assess whether oral exposure to a high concentration fatty acid solution would affect satiety in healthy Australian adults. The secondary aim was to assess whether fatty acid taste sensitivity would modify the aforementioned effect.

  • Using transcranial direct current stimulation to boost the hypoalgesic effects of exercise:: A randomised controlled experimental study

    Exercise is considered a first-line treatment for chronic musculoskeletal pain (Pescatello, 2014). One mechanism contributing to the near-ubiquitous prescription of exercise in chronic pain populations is ‘exercise-induced hypoalgesia’. Exercise-induced hypoalgesia (EIH) is the term used to describe acute reductions in pain sensitivity following exercise (Koltyn, Brellenthin, Cook, Sehgal, & Hillard, 2014). However, in chronic musculoskeletal pain, EIH effects are, at best, small to moderate. Exploration of novel interventions that could bolster EIH effects are therefore warranted. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that provides a promising avenue to boost the EIH response (O'Connell, Marston, Spencer, DeSouza, & Wand, 2018). ’However, the effectiveness of tDCS in enhancing EIH is not known. Therefore, this study will investigate whether tDCS can be used to boost the hypoalgesic effect of isometric exercise .

  • Usability and effectiveness of next generation sound processor used in adult hearing impaired population

  • A multicentre, qualitative evaluation of the impact of advertised Emergency Department (ED) wait time on ED patients, potential patients and other stakeholders.

    The decision to seek out emergency medical care is complex and nuanced. Many factors influence what care to seek and when. Once a facility or provider is chosen, there will be expectations for care competency and timeliness. Acutely unwell or distressed patients hope to see a Health Clinician or Doctor immediately on arrival, however this is rarely achievable. The reality for most patients is that they join a queue for care and wait to be treated. Previously, community health providers and patients have been blinded to the length of those queues. In the era of expanding Information Technology (IT) capabilities, advertised Emergency Department (ED) wait times (real-time, available on the internet) have recently been posted in Australia, including Cabrini ED’s time to see a doctor. There is a paucity of information regarding the impact of this on patients, paramedics and community members. The goal of the study is to explore the potential impact of advertised ED wait times by interviewing consumers and potential consumers of this information. Through this exploration, we hope to provide insight into the positive and negative aspects of this tool, allowing health administrators to determine whether and how to deploy the information. This study will be a prospective, multicentre, qualitative study collecting data via semi-structured interviews with patients (or guardians), paramedics and community members. It will be conducted over 3 months at Cabrini Hospital, Monash Medical Centre and Box Hill emergency departments. Community members (Bolton-Clarke consumers, sports club members and community representatives) will be interviewed either face to face or via telephone. The interviews will be recorded and transcribed. All data will be analysed and a descriptive paper submitted to various biomedical journals. This study aims to explore the impact of advertised ED wait times which may influence future policy decisions, the structure and deployment of wait time information and ongoing wait time and IT metadata application research.

  • Are electric fans effective for keeping people cool in both very-hot-and-dry and hot-and-humid heatwaves?

    In Australia and globally, mean yearly temperatures and heatwaves are on the rise, causing elevated morbidity and mortality rates. It is typically the elderly, poor, and socially isolated who suffer most. Often, these groups lack access to air conditioning, whereas less privileged groups have started using air conditioning more regularly, causing the electricity demand during hot weather periods to increase faster than what existing infrastructure can supply. This mismatch causes regular power failures during heatwaves, which deprive life-saving electricity to those who truly need it. Clearly, alternatives to air conditioning are required. While many cooling alternatives exist, most have never been objectively tested under heatwave conditions. This lack of evidence is detrimental and leads to the spread of misinformation. For example, many major health organizations, including the World Health Organization (WHO), currently advise against the use of electric fans in hot conditions. On the contrary, a recent (2012) Cochrane review concluded that no evidence whatsoever currently exists in the literature supporting or refuting the use of electric fans during heat waves. Following-on, we recently (2015) published a study in the Journal of the American Medical Association demonstrating fan use was better than no fan use for young healthy adults in humid environments at 36°C and 42°C; both conditions at which fan use is commonly discouraged. From a theoretical standpoint, electric fans should be effective in hot and humid conditions because they help increase sweating efficiency, i.e. the amount of sweat that we produce which actually contributes to heat loss. Unlike hot humid conditions, in very-hot and dry conditions, sweating efficiency may be at 100% and therefore fan use may not be beneficial as the increased air speed (when air temperature is above skin temperature) would increase heat gain from the environment through convection without any supplying any additional evaporative heat loss. Therefore, the purpose of this study will be to objectively test the effectiveness of electric fan use for cooling healthy adults during heatwaves in two heatwave conditions (very-hot-and-dry and hot-and-humid). We hypothesize that in very-hot-and-dry conditions, electric fan use will make people hotter, more uncomfortable, increase their cardiovascular strain and increase their rate of dehydration, whereas in the hot-and-humid conditions, fan use will cool people, make them more comfortable and lower their cardiovascular strain at the cost of a slightly elevated sweat rate.

  • Effects of an online behavioural activation intervention combined with self-compassion training on wellbeing, behaviour, and depression symptoms in a non-clinical sample.

    This study will aim to test whether a self-directed behavioural activation intervention is more effective in reducing depression symptoms and increasing subjective wellbeing and value-consistent behaviours in a non-clinical adult sample if enhanced with self-compassion training (EBA condition) than if delivered as a stand-alone intervention (BA condition). Several hypotheses will be tested, including: (a) The mean rate of change in (i) depression symptoms, (ii) positive affect, (iii) negative affect, (iv) satisfaction with life, and (v) value-consistent behaviour will be greater amongst participants in the behavioural activation condition than the waitlist control condition. (b) The mean rate of change in (i) depression symptoms, (ii) positive affect, (iii) negative affect, (iv) satisfaction with life, (v) value-consistent behaviour, and (vi) self-compassion will be greater for participants in the EBA condition than the BA condition. (c) For participants in both the BA and EBA conditions, individuals with greater pre-test depression symptoms will have a larger rate of change in (i) positive affect, (ii) negative affect, and (iii) satisfaction with life than participants in the waitlist control condition. (d) Participants in the EBA condition will be more likely than those in the BA condition to complete online survey measures (which will used as a proxy measure for treatment continuation).

  • Does brain connectivity in healthy adults influence the induction of spatial neglect by non-invasive brain stimulation?

    The aim is determine whether connectivity of the right parietal cortex predicts response to an inhibitory brain stimulation paradigm (TBS), to induce spatial neglect in healthy adults. We hypothesis that the connectivity of the stimulated parietal cortex prior to an inhibitory brain stimulation paradigm, will predict the degree of induced left-sided neglect as measured by behavioural responses.

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