ANZCTR search results

Considering the dearth of research in VR augmented mindfulness in general, and in the use of VR for the management of pain, it is necessary first to trial the training in healthy controls. Therefore, the aim of this study is to generate data on the feasibility and acceptability of VR-augmented mindfulness. We will test the relative efficacy of VR-augmented mindfulness, compared to mindfulness without VR augmentation, an experience of the VR environment without the mindfulness instruction (VR only) and a natural history control (tested with no training). These conditions will be well matched in terms of using the same audiotape (mindfulness and VR-augmented mindfulness) and the same VR scenes (VR-augmented mindfulness and VR-only). This would allow us to generate data on the effect sizes of VR-augmented mindfulness vs mindfulness; and VR-augmented mindfulness vs VR-only on which to power a definitive clinical trial. We hypothesize that VR-augmented mindfulness will be acceptable, feasible and associated with larger effects than mindfulness alone, and that the VR-only group will find the condition credible, but less effective than the two active training groups.

This study aims to evaluate two pain relief medications, oxycodone/naloxone prolonged-release (OXN PR) and oxycodone alone prolonged-release (Oxy PR). The study will assess how effective these medications are at relieving pain and reducing constipation in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have metastatic cancer (Stage IV) and moderate to severe pain. Study details All participants will be randomly assigned (by chance) to either receive a combination drug of oxycodone/naloxone or oxycodone alone. In both groups participants will take two tablets a day, however this dosage may be adjusted if needed by your treating clinician. The study will involve a variety of questionnaires exploring Pain, Quality of life and Bowel movement over a 5 week period initially and if you decide to continue on the study for a total of 11 weeks. It is hoped this study can provide insight into the clinical effectiveness between the two pain medications and their effect on sustained analgesia and bowel function. This study may provide greater knowledge into how pain is treated in patients with advanced cancer.

Mild traumatic brain injury (mTBI) is a common problem, crossing all socioeconomic circumstances and age groups. In children and young adults, concussions account for 90% of all traumatic brain injuries, with one in five children experiencing a concussion by the age of 10 years. Post-concussion syndrome (PCS) is a collection of symptoms including physical (i.e., headaches, dizziness), cognitive (i.e., difficulties with attention, and memory), and behavioural (i.e., sleep difficulties, depression, anxiety) symptoms. Most children have recovered from their concussion injury within a month, but 11% continue to experience symptoms at three or more months, with 2% still having symptoms at twelve months or longer. Multiple clinical practice guidelines and position statements exist to guide the management of concussion in children but have information gaps in the provision of discharge advice and continuation of care. The benefits of clear and consistent discharge information and routine follow-up care are known, but practice variation occurs in clinical settings. This purpose of this research is to adapt clinical pathways to be used in local ambulatory care settings. Clinical pathways tools will include discharge Fact Sheets and eHealth applications. A prospective study of clinical and process centred outcomes prior to implementation of the amended clinical pathway will be performed, followed by an evaluation of the clinical pathway post-intervention. It is hoped that this research will improve follow-up care for children after a concussion injury including facilitating those with ongoing symptoms to seek appropriate care.

This is a sub-study of the SHINE randomised controlled trial (ACTRN12618001498280). In this sub-study, we will also monitor oxygen supply to the brain (by placing a sensor on the forehead). We hope that this will give further information about the changes in oxygen delivery to the brain during placement of breathing tube for babies.

Internationally stroke ranks second among all causes of disability and is adding to considerable worldwide healthcare burden. Over the last 5 years a new procedure to remove clots (Endovascular Thrombectomy - EVT) has been effective for the treatment of acute large strokes, with significant reductions in long term patient disability compared to standard treatment. However, there minimal guidance on blood pressure management during the procedure. The brain is especially vulnerable to low blood pressure during the acute stroke period due to low blood supply, impairment of how the brain regulates blood flow and further falls in blood flow to the brain. High blood pressure may be beneficial due to increased blood flow in areas at risk during this time. It could be harmful due to brain injury process, swelling, and bleeding into the brain. Conversely, relatively low blood pressure could be harmful. Current evidence is limited to large observational studies. This randomised controlled study will examine the safety and efficacy of two systolic blood pressures (SBP) management arms during general anaesthesia for EVT on outcomes in patients with acute ischaemic stroke.

The aim of this project is to determine the feasibility of running a fully-powered randomised controlled trial on the use of high intensity exercise in reducing period pain (dysmenorrhoea). This project will use 30 women aged 18-30 who have primary dysmenorrhoea (period pain not explained by an identifiable pathology). Women will be randomly allocated to an 'Exercise' group or 'Wait-list Control' group. Women in the 'Exercise' group will undertake four high intensity exercise classes per week for 12 weeks total. Both groups will complete a Menstrual Pain Diary during each menstrual period over the 12 weeks. Other outcome measures will include pelvic and period pain scales, anthropometric measurements, fitness level, exercise compliance, analgesic use over the 12 weeks, and any adverse events experienced. These outcomes will assist in determining the feasibility of an appropriately-powered RCT to explore the effectiveness of high intensity exercise on primary dysmenorrhoea.

WalkingTall is a novel neuro-rehabilitation program delivered through a tablet/smart phone and smart socks for people with Parkinson’s that aims to improve mobility and reduce falls. It consists of smart socks, which deliver haptic stepping stimulus via small vibrators, balance and walking exercises, visual and auditory cues delivered via a tablet and mobile phone. Training may be done with the assistance of a trainer, independently or a combination of both. The purpose of this study is to investigate how WalkingTall may improve gait stability and mobility in people living with Parkinson's. It comprises a 2-week neuro-rehabilitation program including a combination of supervised and unsupervised sessions. Our key aims are to collect preliminary evidence for improved step-time variability, determine training dose tolerance and participant safety, identify the characteristics of people most likely to benefit from WalkingTall and engage end-users in the ongoing design process.

This study will investigate the effect of self-directed physical activity and motivational interviewing on quality of life, psychological health and immune outcomes in female breast cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with breast cancer or ductal carcinoma in situ within 3 years and are at least 6 months post-active treatment. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in both groups will be administered 2 components of the intervention: a self-directed physical activity component (supplied with a step count tracker) and a motivational interviewing component. The self-directed physical activity component involves one supervised session by an exercise physiologist at the first week and independent physical activity at home or community using a step tracker throughout 24 weeks. The supervised session will be last 30 minutes for the application of step tracker and jogging or walking at moderate intensity exertion (at their perception of taking some effort but can talk during physical activity). The motivational interviewing components involve a combination of face-to-face and phone calls during self-directed physical activity. The timing of the motivational interviewing component will be randomly allocated to the first 12 weeks or the last 12 weeks. Quality of life, psychological health and immune function will be assessed using questionnaires and blood tests before, during and after the intervention. The study hopes to see the benefits of self-directed physical activity combined with motivational interviewing on the improvement of psychological well-being, quality of life and immune outcomes in female breast cancer survivors. So this program implementation could be rolled out more widely at a low cost in the future in female breast cancer survivors.

Osteoarthritis is a debilitating condition affecting 9% of Australians, and this is likely to increase as our population ages. There are currently no drug treatments for prevention or cure of osteoarthritis, only temporary solutions to treat pain and symptoms. Osteoarthritis can have a huge impact on quality of life and can lead to other complications, like cardiovascular disease. Looking for prevention and treatment options is therefore very important, and dietary oils might provide one potential treatment option. Some research has investigated dietary oils and osteoarthritis. There is some evidence that certain types of oil might have some benefit, but we need to conduct more trials to find out. One of the problems with dietary oils studies is that they are difficult to blind. Blinding means that the participants in the study don’t know which treatment they are receiving, and neither do the researchers. Blinded studies are very useful, because when the treatment is kept secret, any results that are found are more likely to be because of the treatment, and not because of researcher bias or participant belief (placebo effect). We are not sure whether it is possible to blind a dietary oils trial, how participants will handle taking different types of oils, and what impact this might have on their diets, symptoms of arthritis and other health markers like weight and cholesterol. We’d like to answer these questions, to help design a large, blinded, dietary oils study in the future. This study has a couple of main purposes. We want to know: • if people will be able to identify dietary oils, without being told what they are • how people go about consuming the dietary oils (for example, alone, or with food) • whether dietary intake of other foods and oils will be affected • whether consuming different types of dietary oils will impact on symptoms of arthritis, such as pain, and other health markers such as weight and cholesterol levels We will give patients with osteoarthritis three different types of dietary oils for 3 months, and assess how they take the oils, whether they can tell what the type of oil is, whether their diets change, and measure some health markers like lipids and weight. We will also look at pain scores from their arthritis to see if the dietary oils have any therapeutic effect on pain.

The purpose of this trial is to determine, and compare, the effects of intraduodenal versus intragastric administration of quinine on blood glucose, gastric emptying, gut and gluco-regulatory hormones, and gastrointestinal symptoms in comparison to intraduodenal and intragastric water controls respectively.