ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Right Brachiocephalic Vein Origin (RBCVO) Access for Trauma

    Hypovolemic shock due to blood loss, known as haemorrhagic shock, is the most common cause of preventable death after injury. Principles of managing haemorrhagic shock include haemorrhage control and replacing the lost circulating blood volume. This requires venous access, which is a fundamental aspect of trauma resuscitation. In shocked trauma patients, obtaining venous access can be difficult and there are limitations to current methods of obtaining peripheral and central venous access. This project will investigate the use of the brachiocephalic veins for venous access in the resuscitation of shocked adult trauma patients. The origin of the brachiocephalic veins is currently used for venous access in adult and paediatric populations, there is no published literature on what happens to the brachiocephalic veins in shock and the use of the brachiocephalic veins for access in shocked adult trauma patients. The Right Brachiocephalic Vein has been found to be preferable for access in adult patients may stabilised by the surrounding anatomical structure which could prevent vascular collapse collapse in severe shock. If Right Brachiocephalic Vein origin access is found to be feasible in shocked trauma patients, it will provide a new access route for use during trauma resuscitation. This may improve venous access in patients with peripheral circulatory collapse, allowing for earlier replacement of lost blood volume using fluids and blood products. Additionally, vasoactive drugs can be given, and coagulopathies can be corrected earlier in resuscitation. This is vital in managing haemorrhagic shock and may improve patient outcomes. Hence, venous access using the origin of the Right Brachiocephalic Vein may improve resuscitation and decrease preventable deaths after injury due to haemorrhage. The aim of this prospective randomised control trial is to prospectively evaluate the RBCVO central venous access technique in adult trauma patients to determine if the technique is appropriate for access in the trauma resuscitation setting., by comparing it to SCV access. This will include analysis of complications, success rates, efficacy and accuracy. The research question of this study is: How successful is RBCV origin access for the resuscitation of adult trauma patients? The objectives of this study are to: 1. Determine the efficacy of RBCVO access in adult trauma resuscitation 2. Determine the safety of and complications associated with RBCVO access compared to SCV access. 3. Determine how appropriate RBCVO access is for the trauma resuscitation setting. We hypothesize that vascular access using the origin of the RBCVO will be greater than 90% successful in adult major trauma patients.

  • Implementing an allied health reablement program in the community and in residential aged care:

    There is clear evidence from the recent Royal Commission in Aged Care Quality and Safety that (a) older people living in residential aged care and in the community need allied health services to optimise their health and well-being, (b) older people living in residential aged care and in the community are not getting the services they need, and (c) the ways in which allied health services are accessed in the aged care system is not working. The proposed intervention draws on a strong evidence base that reablement principles can improve outcomes for older people in living at home and in residential aged care. Reablement “involves time-limited interventions that are targeted towards a person’s specific goal or desired outcome to adapt to some functional loss or regain confidence and capacity to resume activities”. Some key points about programs that use reablement are they: • Focus on the skills, abilities and social situation a person has to help themselves, rather than doing things for the person; • Are focused, time-limited and goal focused; • Can focus on modifying tasks or the environment to address a loss of function and/or training a new skill and using existing social supports. There is evidence that allied health using reablement principles improve outcomes for older people including physical function, falls prevention, communication, nutrition, personal care and social function. However, the translation of this evidence into practice has not been systematically applied and reported in Australia. To address some of the issues around frailty, falls and social isolation identified in residential aged care and in the community, we will implement and evaluate a multidisciplinary allied health service consisting of physiotherapy, exercise physiology, occupational therapy and speech pathology. Importantly, this service will be based on evidence-based, reablement principles.

  • Effectiveness of Combined Breathwork and Cold Immersion for Psychological and Physiological Measures of Wellbeing and Performance

    This semi-randomised control trial aims to investigate the effectiveness of the Wim Hof breathing method and cold immersion (compared to an active control condition) for promoting stress reduction, resilience, recovery, cognitive functioning, and overall mental health and well-being. The present research combines 24/7 physiological biometric capture, daily experience sampling, and survey measurements across the study period (including a 2-week baseline, 4-week intervention period, and 3-month follow-up period). By measuring physiological, cognitive, and subjective measures, and continuing to monitor participants post-intervention, we aim to contribute to the growing body of knowledge concerning the potential benefits of the Wim Hof Method. In particular, assessing whether it is a suitable and effective strategy for stress reduction, performance optimisation, and mental health enhancement. Hypothesis 1: Onboarding/Exit Measures (Pre/post the 4-week study intervention) We hypothesize that there will be an improvement in post-intervention scores compared to pre-intervention baseline scores across all three conditions. We expect Condition 1 to show greater improvements than Conditions 2 and 3, and Condition 2 to show greater improvement than Condition 3 in the post-intervention outcome measures. Hypothesis 2: Daily Momentary Measures (Pre/post daily intervention) We hypothesise that there will be an improvement in post-daily intervention scores compared to pre-intervention daily scores across all three conditions. We anticipate the improvement to be greater in Conditions 1 and 2, relative to Condition 3, for the momentary outcome measures. Hypothesis 3: Daily Measures (Post daily intervention) We predict better Stroop task scores (lower Stroop interference effect, faster reaction times, and greater accuracy) and N-back task scores (greater accuracy and faster reaction times) in the daily post-intervention cognitive tasks in Conditions 1 and 2, relative to Condition 3. Hypothesis 4: Daily Physiological Recovery (Nightly post-intervention) We predict improved average nightly physiological recovery (greater sleep: quantity (duration) and quality (slow wave sleep and rapid eye movement sleep), and cardiovascular functioning: higher heart rate variability, and lower resting heart rate and respiratory rate) in Condition 1 compared to Condition 2 and 3, and greater recovery in Condition 2 than condition 3.

  • Investigation of Stress Symptoms and Interventions in Firefighters

    Stress is a ubiquitous concern for people however it may be more prevalent in firefighters who routinely face arduous working conditions. Chronic stress has been shown to have detrimental effects on mental health and the ability to self-regulate mood and behaviour. Neurofeedback (NFB) is a brain-computer interface biofeedback intervention. The objective was to investigate whether NFB could substantially alter self-regulation capacity positively to improve self reported symptoms of stress. There were three hypotheses proposed including, H1: firefighters in the experimental group would show improved scores on self-report measures pre and post intervention. H2: firefighters in the experimental group would maintain these changes at long term follow up. H3: firefighters in the control group would show no change from baseline to follow up. Neurofeedback training involves watching a computer display to use mental activity to control brain waves of interest. The display and sound changes, in real time, as changes in participants’ brainwaves occurs. The feedback allows for the participants learn to regulate their mental activity. If the mental activity successfully changes the brainwaves in the desired direction to reduce stress and produce calming, participants are rewarded with points. With practice, consistent with how learning occurs participants can improve their response to stress.

  • Acceptability and Feasibility of a Family Intervention for Autistic Children Who Are Bullied

    We will conduct a clinical case series to investigate the acceptability and feasibility of Resilience Triple P for mainstream primary school students in Australia who have been diagnosed with ASD and are bullied by their peers. We will recruit 20 to 25 families and they will complete Resilience Triple P immediately. Children, parents, and teachers (if applicable) will complete assessments. It is expected families of autistic children will be satisfied with Resilience Triple P as an intervention for decreasing bullying victimisation and they will provide important insights into improving the delivery. Autistic children who participate in Resilience Triple P are expected to experience reductions in bullying victimisation, mental health problems, and school refusal. It is expected each family of an autistic child will use a different combination of strategies from Resilience Triple P depending on what their specific goals are.

  • An evaluation of a mental health literacy program in primary schools

    Mental disorders are common in childhood, but many young people do not receive adequate professional support when they experience mental ill health. Help-seeking interventions may bridge this substantial treatment gap. In adolescents, there is evidence that interventions targeting mental health literacy and mental health stigma can increase help-seeking. However, there has been limited research on such interventions in primary-school aged children. The aim of the proposed study is to evaluate the effectiveness of the newly established Thriving Minds program in increasing literacy, reducing stigma and promoting help-seeking in children aged 7-12 years. Children from at least 12 primary schools will participate in a pragmatic controlled trial to assess intervention effects, while select school staff will participate in semi-structured interviews to evaluate program satisfaction and identify other observable effects of the intervention on student learning and wellbeing. It is expected that Thriving Minds will improve children's help-seeking for difficult emotions. The proposed study will provide important new knowledge on the effectiveness and acceptability of mental health awareness programs in children. If found to be effective, the Thriving Minds program could be scaled up for delivery across Australia, providing a low-intensity and accessible intervention to promote mental health and timely help-seeking in our children, now and into the future.

  • A one year follow-up study of the MedWalk South Australian participants to assess maintenance of lifestyle changes and selected health measures.

    Research trials have demonstrated the short-term benefits of the Mediterranean diet (MedDiet), showing improvements to cholesterol levels, blood pressure and antioxidant levels in the body. Evidence is quite strong that people who follow a MedDiet have improved cardiovascular health, and now we are trying to find out if it might also protect us against dementia and cognitive decline. During 2021 and 2022 we completed a 12-month long study called MedWalk with 74 older Australians. We asked half of them to try the MedDiet, while the other half stayed on their usual diet. Those following the MedDiet were also asked to be active, aiming for 30 minutes of physical activity per day. We were interested in their cognitive function, but also their mental health and wellbeing, their cardiovascular health, fitness and their frailty. While 12 months will tell us about some short-term changes, it is not really long enough to see changes in long-term cognition or dementia diagnoses. So this follow-up study will ask those same 74 people to come in and have some measures taken, to see if they have kept on following the MedDiet, kept up the physical activity, and to see if there is any benefits to their cogntive health 24 months since starting the MedWalk trial (12 months since their final MedWalk visit). We are hoping to see that our participants have maintained some aspects of the MedDiet and their physical activity levels from the study, and we may perhaps see that the control group have also adopted some of these changes since finishing the trial. If we see benefits to cognitive health or in some of the other outcomes, this will be strong promotion for older Australians to adopt a more Mediterranean lifestyle through diet and physical activity.

  • A trial to assess the visual performance of novel myopia management spectacles in short-sighted young adults

    The purpose of this trial is to compare the visual performance of various novel myopia management spectacles to a commercial control spectacle in myopic young adults. Visual performance will be assessed with vision testing and questionnaires. It is hypothesized the visual performance of test spectacles will be no different to control spectacles.

  • A digital anxiety intervention for children with reading difficulties

    The overall goal of this research is to evaluate the efficacy of a digital anxiety intervention developed for children with poor reading. We are aiming to answer the following research question: Does a digital anxiety intervention modified for children with poor reading significantly reduce anxiety symptoms and result in greater remission of anxiety for children aged 7 to 12 years compared to the control condition? We aim to evaluate this through a randomised controlled trial (RCT) with a primary timepoint (post-intervention) at 12 weeks, an interim timepoint (mid-intervention) at 5 weeks, and a secondary timepoint (follow-up) at 24 weeks. We hypothesise that the intervention will significantly improve children's anxiety.

  • Energy needs in adult critically ill patients with infection.

    Indirect calorimetry is a highly accurate instrument which measures energy needs by monitoring the amount of oxygen consumed and carbon dioxide produced. Despite best practice recommendations to use indirect calorimetry in critically ill patients, clinicians often rely on less accurate and quicker estimations of energy needs using predictive equations. There is little published data on how frequent indirect calorimetry measures should be undertaken to capture energy changes in patients with infection during the course of their ICU admission in a busy ICU setting. The primary aims of this study are to compare measured energy expenditure using once daily indirect calorimetry with usual standard of care estimations using predictive methods and determine feasibility of indirect calorimetry from a practitioner perspective, in critically ill patients with a suspected infection. The secondary aim is to describe correlations between measured energy expenditure and infection markers and infection severity predictors. This is a prospective quantitative observational study conducted at Sir Charles Gairdner Hospital ICU that commenced participant recruitment on 17th August 2021 and completed participant recruitment on 9th March 2023. Inclusion criteria includes: Critically ill adult (18 years or older) mechanically ventilated patients with a suspected infection, requiring vasopressors within 24hours of admission and expected to stay within the ICU for at least 24 hours.

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