ANZCTR search results

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

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34008 results sorted by trial registration date.
  • Effect of Pre-procedure Video Education on Patient Experience During Intravitreal Injections: A Randomised Controlled Trial

    Intravitreal injections are commonly used to treat a range of retinal conditions, and patients may experience anxiety or have questions about the procedure. This randomised controlled trial investigates whether providing an educational video explaining the injection process, potential risks and benefits, and aftercare improves patients’ experience compared with standard clinician consent and counselling. Patient-reported outcomes, including pain, anxiety and satisfaction, are assessed immediately after the injection using a 0-100 numeric rating scale.

  • Effect of Periorbital Vibration Anaesthesia on Patient Experience During Intravitreal Injections: A Randomised Controlled Trial

    Intravitreal injections are commonly used to treat a range of retinal conditions, but the procedure can cause pain and anxiety for patients. This randomised controlled trial investigates whether applying periorbital vibration using the Dermacuro Vibration Neural Distraction Device during intravitreal injections improves patients’ experience compared with standard care. Patient-reported pain, anxiety and satisfaction are assessed immediately after the injection using a 0-100 numeric rating scale.

  • The impact of an exercise and education program on quality of life for people with postural orthostatic tachycardia syndrome (POTS)

    This study is a multi-site randomised controlled trial. The purpose of this study is to evaluate an individualised 12-week exercise and education rehabilitation program for individuals with Postural Orthostatic Tachycardia Syndrome (POTS). It aims to determine if the program is effective at improving quality of life, symptom burden and exercise capacity in comparison to a control group. Additionally, this study aims to determine if delivery of the program across multiple sites is feasible and whether the co-designed clinician toolkit and implementation strategy are acceptable and appropriate for delivering the intervention.

  • Testing the safety and feasibility of light therapy and electrical brain stimulation in healthy adults and adults with recent concussion

    This study will assess the safety and practicality of combining two non-invasive brain treatments in healthy adults and adults recovering from a recent concussion. Photobiomodulation uses a headset and a small nasal applicator to deliver near-infrared light, while transcranial electrical stimulation delivers a weak electrical current through two pads on the scalp. Six adults aged 18 to 40 (three healthy adults and three with a recent concussion) will use both treatments together at home for 25 minutes per day over one week. Researchers will assess side effects, treatment tolerability, adherence and participants' ability to use the devices safely at home, alongside exploratory measures of concussion symptoms, mood, sleep, cognitive performance and brain activity. The findings will help determine whether the combined treatment is safe and feasible and inform the subsequent randomised controlled trial.

  • A study to assessing a device to measure the efficiency of extracorporeal life support machines

    This single-centre prospective observational study investigates extracorporeal membrane oxygenation (ECMO) circuit performance using ultrasound dilution technology. The parent study (OXBV) assesses membrane oxygenator clot burden in all adult ECMO patients. A predefined sub-study (2TIPS) evaluates recirculation fraction exclusively in patients receiving veno-venous ECMO. Both studies utilise the Transonic ELSA® monitor and do not alter standard clinical care; we are comparing the use of this monitor, to the performance of our standard markers of clot burden and recirculation.

  • A co-designed exercise promotion program for multiple sclerosis (MS) healthcare providers and people with MS

    Evidence indicates that exercise is safe and improves many clinical outcomes, including physical fitness, functional abilities, fatigue, depression and cognitive function in people with MS. However, many people with MS do not engage in the levels of exercise needed to produce the best health outcomes for their condition. In this project, researchers will develop and test an online training program, targeting neurologists and nurses to promote exercise to their patients with MS. We will measure training success based on the healthcare providers’ confidence, knowledge and behaviour towards promoting exercise to people with MS after completing the online training program (PULSE-HCP); as well as the change in exercise levels of people with MS after they engage in a PULSE-HCP clinical consultation. First, six healthcare professionals will pilot-test the training and give feedback via interviews, which will be used to refine it. Around 33 healthcare professionals will then complete the refined training program and practice their exercise-promotion consultation to two persons with MS (66 total). To prepare for a large-scale roll-out of the framework, our team will identify the cost of healthcare provider training and the outcomes, mechanisms and contexts which make the framework realistic for delivery within the Australian healthcare system.

  • Cyclists perception of comfort, metabolic demand and biomechanics in cyclists with a novel bicycle saddle

    Compare the perception of comfort, biomechanics and physiological responses of cycling with a novel saddle compared to a reference cycling saddle. Participants cycling for a short duration on a cycle ergometer using each saddle in random order whilst perception of comfort, biomechanics and physiological responses will be monitored. Hypothesis is that the novel saddle will improve comfort and optimise cycling biomechanics compared to the control saddle.

  • Optimisation of Perfectionism Micro-Interventions for Perfectionism and Disordered Eating Psychopathology in At-Risk Young Adults

    Perfectionism, holding oneself to excessively high standards alongside harsh self-criticism, is rising among young people and is a transdiagnostic risk factor for anxiety, depression, eating disorders, and obsessive-compulsive disorder, as well as being associated with poorer wellbeing, stress, and burnout. Research has begun to develop brief, self-guided and online interventions to better which help address perfectionism, However, it is currently unknown which components of perfectionism interventions are most effective, as there are few if any trials that isolate and compare them. The proposed project addresses this gap in young adults aged 18 to 25 years. Using the Multiphase Optimisation Strategy (MOST) framework, we will test the individual and combined effects of common perfectionism intervention components delivered as brief online "micro-interventions", In doing so, we aim to identify the most effective and efficient combination, to inform the design of accessible, low-cost interventions for perfectionism that can produce change in the shortest time possible, better meeting the needs of young people and offering potential preventative benefit for serious mental health problems.

  • Efficacy and safety of prehospital fibrinogen early in severe trauma study: A feasibility and two arm phase II study (PRE-FEISTY II)(Stage 2).

    This study aims to investigate the feasibility of administering fibrinogen concentrate in the setting of severe traumatic bleeding in the prehospital setting. This is being done to evaluate the possibility of conducting a prehospital arm of the forthcoming FEISTY II study.

  • The effect of virtual reality induced optic flow manipulations during cycling on exercise engagement, experiences, and clinical outcomes in people with knee osteoarthritis

    Despite clinical guidelines recommending exercise for the management of knee osteoarthritis (OA), many Australians with painful knee OA are physically inactive. Pain during exercise can reduce initial and sustained exercise engagement, making it difficult for people with knee OA to maintain regular exercise. Although exercise can improve pain, function, and long-term health outcomes, new strategies are needed to improve exercise uptake and engagement in people with arthritis. Virtual reality (VR) technology holds promise as a strategy to reduce exercise barriers and increase exercise engagement and experiences, and thus, have greater effects on clinical outcomes including knee pain and physical function. This study will use a parallel-group randomised trial design. Participants will be randomised to one of two active treatment groups: VR-enhanced cycling with increased optic flow or VR-enhanced cycling with decreased optic flow. Both groups will receive two in-person, one-on-one treatment sessions per week over six weeks (total of twelve sessions). The sessions will be delivered by an allied health professional (physiotherapist, occupational therapist). The primary outcomes will be exercise engagement (total work during cycling) and experiences (affective valance via Feeling Scale). Secondary outcomes will include knee pain (WOMAC pain subscale), physical function (WOMAC function subscale), knee pain intensity during cycling (101-point NRS), perceived exertion during cycling (Borg scale), exercise engagement (average/maximal power, cycling duration), exercise enjoyment (101-point NRS, Physical Activity Enjoyment Scale), physical activity (The Active Australia survey), pain interference (BPI-PI), and motion sickness symptoms during cycling (FMS), pain self-efficacy (PSEQ), health related quality of life (EQ-5D), pain-related fear of movement (Brief FoM), bodily perception of the knee (FreKAQ), knee osteoarthritis conceptualization (OACS), pain catastrophizing (PCS), positive and negative affect (PANAS-SF), psychological distress (PHQ-4), fatigue level (ROF) and treatment expectation.

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