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The effect of a parental preparation video (Take 5) on child and parent anxiety during anaesthetic induction. A randomised controlled trial.
Undergoing surgery can be a stressful and anxiety provoking process both for parents and the child undergoing surgery. Children are particularly vulnerable to experiencing procedural anxiety in the context of anaesthetic induction, especially due to varying and developing cognitive abilities, inability to self-regulate, and limited knowledge and/or experience of the healthcare environment. Young children are especially unlikely to engage in self-coping strategies, and instead rely on primary attachment figures for emotional regulation and behavioural cues. Previous research has demonstrated that parents’ own responses are influential for paediatric procedural coping and distress. As such, providing parents of children undergoing surgery with psychoeducation resources which can reduce their anxiety and promote coping strategies for both them and their child, may reduce negative experiences and post-operative outcomes (e.g., emergence delirium, pain severity, increased analgesic requirements, and longer-term poor psychological sequelae). The “Take Five” video resource for parents is a newly developed resource for procedural distress, and preliminary data from a study in young children with burn injuries indicates it is effective for improving parent and child experiences of burn wound care. We believe that this resource has the potential to significantly improve anaesthetic induction for parents and children and reduce poor post-operative outcomes.
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Mepolizumab for treatment of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome - A pilot study
This is a multi site open label pilot study designed to assess feasibility of further studies looking at the utility of mepolizumab in the treatment of DRESS syndrome. This is an investigator initiated study, with study drug being provided by GlaxoSmithKline. DRESS syndrome is a potentially life threatening, idiosyncratic adverse drug reaction. It is typically accompanied by morbilliform rash, fever, lymphadenopathy, haematological abnormalities including eosinophilia and the presence of atypical lymphocytes, and multiple organ involvement. A number of drugs can cause DRESS syndrome and the common causes include antiepileptic drugs, allopurinol and sulfonamides. We aim to recruit 8 participants over 1.5 - 2 years across the study sites. Mepolizumab, a humanised monoclonal antibody that targets IL5, will be used in conjunction with standard therapy in participants with DRESS syndrome. Mepolizumab is currently approved for use in refractory eosinophilic asthma. Participants will be involved in the study for ~6 months. In addition to standard care investigations/monitoring, blood samples for cytokine analysis and lymphocyte profiling, and patient reported outcome measures will be collected at each visit.
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Investigating the effect of partial meal replacements on weight loss for people awaiting knee or hip arthroplasty
Over half of the people undergoing total knee or total hip arthroplasty (TKA, THA) in Australia have obesity (Body mass index (BMI): 30 kg/m2 or more). Obesity is associated with greater complication rates, lower absolute recovery in mobility and patient-reported pain and function, and higher costs of care following TKA or THA. While weight loss prior to surgery is thought to be beneficial, there is no definitive data to support that this will improve outcomes following surgery, or as to what the most appropriate or effective method of weight loss is. Therefore, this study will test the feasibility and effectiveness of a calorie-restricted partial meal replacement (2 shakes plus a meal, total 1200 Kcal/day) for people with obesity prior to undergoing TKA or THA. This study will assess 30 patients as to whether >50% of people waiting for knee or hip arthroplasty can achieve 5% or more weight loss in 3 months using a clinician-supported partial meal replacement weight loss program.
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Can hyperhydration improve half-marathon time-trial performance in hot conditions?
Exercise performance is impaired in hot conditions compared with temperate conditions. During exercise in such thermally stressful conditions, fluid loss through sweat production to liberate heat from the body is accelerated, which can adversely impact cardiovascular and thermoregulatory function and ultimately hinder exercise performance. To increase the total fluid pool available for sweat production, ingestion of nutritional aids such as glycerol and sodium prior to exercise may increase total body water above normal body water levels (i.e., euhydration) prior to exercise, which is known as hyperhydration. This topic requires further investigation to determine if hyperhydration is a viable preparation strategy for endurance running in hot conditions. The hypothesis for this study is that the combined ingestion of glycerol and sodium will result in a significantly greater fluid retention than the control and this will improve half-marathon time-trial performance in hot ambient conditions.
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Pulse oximeters in Paediatric Patients
Paediatric patients undergoing cardiac surgery or inpatient in the intensive care unit at the Royal Children’s Hospital in Melbourne (RCH) will have a study pulse oximeter (Contec Pulse Oximeter, model CMS50DL) placed on a digit when an arterial blood gas is being drawn for routine clinical management. At this time, the patient’s vital signs and specific values from the arterial blood gas measurements will be recorded and, ultimately, the usual RCH pulse oximetry readings and arterial blood gas co-oximetry values will be compared with study pulse oximeter readings. All paediatric patients undergoing cardiac surgery at RCH during the specified time period will be eligible and may be subjects in this study. Patients and/or the patient’s legally acceptable representative will be provided with a study information sheet. Verbal consent will be obtained for all patients. Patients and/or the patient’s legally acceptable representative will also be asked to fill out a survey as part of the study. Study hypothesis: We are conducting this study to test whether a low-priced pulse oximeter (a medical device to measure the amount of oxygen in the blood) is accurate in paediatric patients, particularly those undergoing cardiac surgery.
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Pilot Study of Preoperative Stereotactic Radiosurgery for Brain Metastases
Whole Brain Radiotherapy (WBRT), Stereotactic RadioSurgery (SRS) and NeuroSurgery (NS) have been used to treat brain metastases (BM) for many years. There has not been any research that tells us which is the best way to use these treatments for individual patients with BM. At present, any combination of SRS, NS and WBRT is considered acceptable. This research aims to evaluate whether changing the sequence of two routinely offered treatment options (SRS and NS), will improve the management outcomes of patients with brain metastasis. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed on MRI of the brain with metastatic brain tumours amenable to a combination of SRS / NS and have a life expectancy of greater than 6 months. Study details All participants will first receive SRS; a standard non-surgical radiation therapy used to treat small tumours of the brain, using precisely focused radiation beams. SRS is not surgery in the ordinary sense, because there is no incision involved and general anesthesia is not required for adults. Treatment will involve an MRI/CT planning session taking approximately 1 hour each, followed by initiation of treatment within 1 week of planning. SRS will be delivered face-to-face in the radiotherapy department. Each treatment session will take up to 1 hour covering initial treatment set-up through to treatment delivery. The number of treatment sessions could range between 1 and 5 sessions delivered over a 1 week period. The number of sessions are based on the size, location, and number of brain metastases. All participants will undergo NS 1-3 days after completion of SRS, An MRI scan is routinely performed 2 days after NS to assess the outcome of the operation. Follow-up of participants will occur at 1 month and 3 months after treatment completion, as well as 3-monthly for the first year after treatment and 6-monthly for the second year after treatment. Follow-up involves surveillance MRI imaging, assessing for side effects of treatments / complications and the efficacy of the treatments. Trial participants will be invited to participate in the optional translational sub-study involving the collection of blood and tissue samples for molecular/laboratory evaluation before treatment, during SRS, after treatment completion and at the time of post treatment disease progression. After the sub-study is completed, any remaining blood and tissue samples collected, will be 'banked' or stored for future research. How may the study impact practice? It is hoped that this approach will decrease the risk of short and long-term complications, in addition to improving the chance of controlling the tumour in the cavity left in the brain after removal of a brain metastasis by NS. The results of this study may also help clinicians to determine which initial treatments to offer people with brain metastases in the future.
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Effectiveness and safety of outpatient versus inpatient balloon cervical ripening preceding induction of labour
Induction of labour (IOL) is one of the most frequent obstetric interventions, being performed in more than 100,000 pregnant women in Australia every year. The first phase of IOL consists of preparation of the cervix, which is often done with the placement of a balloon catheter through the birth canal for 12-24 hours. This procedure is effective, safe and generally performed in hospital. This study will not only investigate whether cervical ripening with a balloon catheter can be performed safely and effectively at home after insertion in hospital, but also establish a network of obstetric services in Australia. If we show that cervical ripening with a balloon catheter can be safely and effectively performed at home, this will reduce significantly the number of admissions and healthcare costs.
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Investigating the effect of tranexamic acid on recovery time in patients undergoing total knee replacements
The purpose of the study is to evaluate a product called Tranexamic Acid (TXA) and its best use in patients who are undergoing total knee replacement. The product is currently used to reduce bleeding during and after surgical procedures. This can lessen the chance of a blood transfusion and may decrease pain, swelling and recovery time following the operation. Tranexamic Acid is already routinely used by surgeons for patients having joint replacements but there is currently no accurate information about how to dose individual patients with this medication to achieve the best results. This study will assess whether different treatment durations and doses will lead to better patient outcomes. The form of TXA that we are using in this study is one single dose in the vein-intravenously and/or an oral tablet. There are 2 treatment groups: Group 1 –Receives 1 gram of TXA intravenously 1 hour prior to surgery Group 2 – Receives 1 gram of TXA intravenously TXA 1 hour before surgery and post-operatively oral dose of 2 grams 8th hourly for a total of 6 doses.
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The Western Australian Heart Valve Study
The West Australian Heart Valves Study (WAVES) aims to improve patient outcomes in valvular heart disease. The study aims to achieve this via two separate components: 1) A registry that includes data linkage of mortality and hospital morbidity records of all patients who have had a heart valve replacement and/or repair in one of the 3 tertiary public hospitals in Western Australia since 2010 and 2) An observational cohort study of all living patients in the registry to determine health outcomes, medication use and patient reported outcomes such as quality of life, functional capacity and life disability.
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Feasibility and impact of a physical activity and lifestyle program for Aboriginal families with Machado-Joseph disease living in the Top End of Australia
The most common spinocerebellar ataxia worldwide, Machado-Joseph disease (MJD) has the highest estimated prevalence in affected Aboriginal communities of the Top End of Australia. MJD, or spinocerebellar ataxia 3 (SCA3), is a rare autosomal dominant neurodegenerative disease that leads to progressive ataxia and functional decline. The ‘Staying Strong Toolbox’ is a physical activity and lifestyle program designed by Aboriginal families living in Groote Eylandt and Ngukurr, to keep their families walking and moving around. Families with MJD in these communities who were concerned about their declining mobility partnered with the MJD Foundation and university researchers to co-design the Staying Strong Toolbox, based on their experiences and what is known from MJD research. The aim of this study was in order to determine the feasibility and impact of the Staying Strong Toolbox program on walking and moving around for Aboriginal families with MJD in the Top End of Australia. A mixed method multiple case study design was used to pilot the Staying Strong Toolbox. Eight individuals with MJD participated in the program for four weeks. Participants tailored their own program using the Toolbox workbook. Families, support workers and researchers facilitated each individual’s program. Feasibility was determined through program participation, adherence, coinciding or serious adverse events, participant acceptability and cost. Impact was determined through measures of mobility, ataxia, steps, quality of life, wellbeing and goal attainment, assessed before and after the program.