ANZCTR search results

This single-arm feasibility trial evaluates the acceptability and practicality of an 8-week intervention combining a structured learn to swim program and (pain) educational sessions aimed at reducing LBP. Participants with LBP will engage in supervised swimming lessons, complemented by an educational content on pain management, physical activity benefits, and self-care strategies. The latter will comprise of two short videos. Primary objective(s) is to assess feasibility indicators, including recruitment and retention rates, adherence to learning to swim, and fidelity of the education sessions. Secondary objectives explore outcomes related to preliminary effects on pain intensity, disability, self-efficacy, fear behaviors and physical activity levels to inform the potential clinical benefits of the program. Hypothesis: This feasibility and small single-arm trial will show participant recruitment, retention and baseline data completion along with follow up rates to be within pre-determined levels. Further, participants will show trends towards greater self-efficacy (belief), and reduced pain and disability - associated with participation in an education and learn to swim program.

Peripheral intravenous catheters (PIVCs) are catheters that are inserted into peripheral veins to give medical treatment such as medicines, fluids, and blood transfusions. PIVCs are the most frequently used vascular access device in Australia. This is largely due to the current workforce model in which most PIVC inserters are doctors and nurses (generalist) inserting PIVCs within their existing roles. There are, however, alternate intravenous (IV) devices available which a specialist in Vascular Access has the specialised knowledge and skills available to insert. Our research project aims to find out whether the standard practice of a PIVC device being inserted by your bedside nurse or doctor affects how long the IV device functions and patient satisfaction. Hypothesis 1: The hypothesis for the feasibility of this study is that we will be able to recruit the required number of patients and they will remain within the study for the duration of data collection. The study will adhere to the processes outlined in the study protocol, and data will be collected and complete. Hypothesis 2: The hypothesis for the clinical outcome of the study is that the Vascular Access Specialist will be more successful than usual care in peripheral intravenous catheter insertion with lower incidence of failure and complications and less pain to the patient.

The purpose of this research is to determine the effectiveness of laser treatment on the leg or arm that will be used to reconstruct your mouth after a removal of cancer before the surgery in reducing hair density in the mouth, and to assess overall satisfaction, including comfort and oral hygiene post-surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo free flap reconstruction using hair-bearing donor site. Study Details: By participating in this study, you will be randomised to either the control group (no laser hair removal treatment) or the intervention group (laser hair removal treatment). Following your surgery, an assessment will be conducted while you are still in hospital to review your healing of donor site/free flap as a standard of care. Hair density measurements and a review of the free flap will also be conducted at your routine post operative review at 4 weeks and 12 weeks post-op. Functional and health-related quality of life [HRQOL] patient reported outcome data will be collected using the FACE-Q Head and Neck Module questionnaire at the first appointment and 12 weeks postop. It is hoped that findings from this study will help clinicians and researchers understand the utility of pre-operative laser treatment in improving quality of life for those undergoing head and neck reconstruction.

This study seeks to improve mid to long term outcomes and reduce frailty in post-TAVR patients by implementing a 3-month CR program in an outpatient setting which will include individualised exercise and education. The proposed study aims to provide a model of care that can be implemented in future community settings. Study hypothesis: 1) Patients who engage in outpatient exercise training program will have reduced frailty at six-months post-TAVR, and 2) patients who benefit most can be predicted.

AURORA is an Australasian multisite observational cohort study and biobank study that is seeking to create a representative data set on the current cancer features, diagnostics, treatments and outcomes for people diagnosed with thoracic cancers. Who is it for? You may be eligible for this study if you are an adult who has suspected or positively been diagnosed with a thoracic cancer, including non-small cell lung cancer, small cell lung cancer, mesothelioma, thymoma, thymic carcinoma, and/or carcinoid tumours. If you are eligible for this study, you may be enrolled at diagnosis, upon referral to a participating centre, or at any stage of your cancer treatment journey. Study details Participants who choose to enrol in this study may be asked if they would like to provide blood and tissue samples, complete questionnaires about their symptoms, and permit access to health service data (from Medicare or the medicines/pharmacy database). These activities usually do not require additional study visits; instead, they will take place during regular appointments. Data about cancer and treatments will be collected as part of routine care follow-up, approximately every 3 to 6 months for as long as care is ongoing. As this is an observational study, participants will not be offered any non-standard of care treatments for their cancer. Participants who have previously been involved in cancer studies (Thoracic Malignancies Study [Peter Mac, 2012–2018] or Australian Registry and Biobank of Thoracic Cancers [Australian sites, 2018–2024]) will have their data and follow-up transitioned to this study, which replaces the previous study protocols. The ethics committee has determined that no further action is required from participants for this transition to take place. It is hoped that this study will allow clinicians and researchers to better understand thoracic cancers, how these are being treated and how patients are responding to their chosen cancer treatments in Australian clinical practice. It is hoped this information can then be used to identify the best diagnosis methods and the most effective treatments for the different types of thoracic cancer, which can then be used to provide better outcomes for future patients with thoracic cancer.

In this randomised, double-blind, placebo-controlled study, 60 adults aged 40 to 75 years with knee osteoarthritis will be randomly assigned to receive either topical administrations of a gel containing curcumin (VAS101) or a placebo. These gels will be applied every 2 days for 28 days. Changes in knee pain and osteoarthritis symptoms will be examined using validated self-report measures, several performance-based tasks, and a urinary marker associated with disease progression in osteoarthritis. Changes in the use of rescue medications for knee pain will also be examined over time. It is hypothesised that compared to the placebo gel, the application of VAS101 will be associated with a greater reduction in knee pain and other knee-related osteoarthritis symptoms; and larger improvements in several performance-based tasks.

Many Australians do not realise that they engage in harmful drinking behaviours and meet diagnostic criteria for alcohol use disorder (AUD). If they are aware, many do not feel motivated to reduce or cease their drinking. While brief motivational interventions have been shown to increase motivation to reduce drinking and therefore, improve treatment outcomes in individuals with AUD, effect sizes are modest at best. Neuropsychological feedback (NPF) is an evidence-based intervention that can be delivered as a brief intervention, and has been found to improve clinical outcomes in other neuropsychological and mental health conditions. Yet, its efficacy and acceptability for AUD remain unclear. In this RCT, we aimed to investigate the efficacy and acceptability of NPF for AUD, compared with an active control, a brief motivational intervention. We hypothesised that adults with AUD who receive NPF would show greater reduction in alcohol use and greater improvement in clinical outcomes (i.e., alcohol craving, psychological distress, and alcohol-related self-efficacy) than those who receive a traditional brief motivational intervention.

Classroom activity breaks have gained traction as an effective strategy for increasing student on task behaviour and academic achievement. Despite these promising results, there remains a gap in the research regarding the effectiveness of activity breaks in secondary school environments. Strength in Numbers is an innovative educational pedagogy that integrates muscle strengthening activities into mathematics lessons. The intervention consists of a series of 5-minute videos that presents numeracy questions aligned with the NSW mathematics syllabus. Students indicate their answer by performing a corresponding muscle-strengthening activity. These activities are designed to be simple, quick, and effective and require no additional equipment or space. It is hypothesised that by combining movement and syllabus outcomes students will find learning less stressful and may improve on task behaviour for up to 30 minutes following the intervention.

This study aims to evaluate gyrocardiography (GCG) as a diagnostic screening tool that detects the presence of aortic stenosis. GCG data will be obtained from 300 participants with either normal aortic valves or mild, moderate or severe aortic stenosis. The results of the GCG data will be compared to that obtained by echocardiography, the gold standard. We hypothesise that GCG will accurately identify aortic stenosis with high sensitivity and specificity - it will be able to detect patients who truly have the disease, and exclude those that do not. This will benefit patients by improving doctors’ ability to diagnose aortic stenosis and more quickly refer onwards for treatment that may be needed.

This study will compare the effects of simplified sleep study testing (with fewer monitoring channels than usual) versus full sleep studies for the diagnosis of obstructive sleep apnea (OSA), by investigating the accuracy of 3 different simplified sleep study devices, their impacts on physician decision-making and important patient outcomes (including symptoms of daytime sleepiness) and whether the use of simplified testing devices in the management of OSA is associated with significant cost savings. The study hypothesis is that limited-channel sleep study testing is accurate, effective and cost-effective compared to full sleep study testing in the diagnosis and management of patients with suspected OSA.