ANZCTR search results

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

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31399 results sorted by trial registration date.
  • Opioid Requirements After Discharge following Surgery

    This study examines opioid prescriptions that are given to patients following a wide variety of common surgery types. One week following going home, patients will be asked to fill out an online survey via their smart phone or via phone with a research nurse. The amount of opioid used will be examined and pain crises explored. This data will be used to create a prediction model to predict patients' requirements so that unused opioids in the community can be minimised while protecting patients from pain crises.

  • Effects of a probiotic intervention on cognitive symptoms and gut-brain biomarkers in multiple sclerosis (MS); a pilot study.

    This study will be a pilot examination of the effectiveness of a multi-strain probiotic intervention to improve cognitive symptoms (primary outcome variables), and cognition-related fatigue, everyday functioning and health-related quality of life (secondary outcome variables) in people living with Relapsing Remitting MS. The study will also examine the potentially important relationship between gut microbial imbalance, kynurenine pathway biomarkers, and cognitive symptoms in this population. The study will broaden our understanding of the role of the gut-brain connection in MS pathogenesis. It is a requisite step in exploring the innovative application of probiotics to improve cognitive symptomology and associated clinical and psychosocial outcomes in people living with MS.

  • Comparing effects of knee osteoarthritis educational information, with and without pathoanatomical content, on consumer osteoarthritis management beliefs: An online randomised controlled trial.

    We are conducting a trial to evaluate whether the removal of pathoanatomically-based biological information about knee osteoarthritis from a patient information pamphlet changes consumer management beliefs, compared to a standard information pamphlet that includes pathoanatomical information. The entire trial will be administered in one single online survey. Participants will initially complete screening questions within the survey to determine eligibility. Eligible participants will then complete baseline outcome measures before being randomly allocated to one of two groups, both of whom will then be asked to immediately read a digital information pamphlet about knee osteoarthritis on screen: i) Control group: the pamphlet will contain information about osteoarthritis including biological pathoanatomical information and language about osteoarthritis ii) Experimental group: the same pamphlet as the Control group, but with all pathoanatomical information and language relating to the structure of an osteoarthritis joint removed. All participants will complete outcome measures again, immediately after reading their allocated digital information pamphlet.

  • Interactive SNAP (Smoking/Nutrition/Alcohol/Physical Activity) program for adolescents delivered with Augmented Reality technology: A Qualitative Study

    Study Purpose: to understand the general publics opinion of delivering health information using augmented reality, and any factors that improve/reduce its perceived effectiveness. Description: we will demonstrate health education delivered via an app called Zappar, which works with an AR poster we developed with adolescents. Our study involves interviews designed to understand peoples opinions on digital education, including our intervention in particular, and learn the perceived strengths and weaknesses of our intervention. Study Hypothesis: Education via AR interventions are an acceptable alternative to adolescents

  • Blood sampling by venepuncture or intravenous cannula in moderate acuity emergency department patients.

    The proposed research project is a study on blood sampling from venepuncture and intravenous cannulas. Venepuncture is when a needle is put into a vein for the specific purpose of drawing blood. Intravenous cannulas are little plastic tubes that are often put into veins to enable fluids or medications to be given. They can also be used for collecting blood. Sometimes when blood is collected through a cannula it can lead to its premature failure. This would mean that the cannula would be removed earlier than expected with the possibility of another being inserted. This study seeks to determine if collecting blood through an intravenous cannula does not increase the frequency of failure when blood is instead only collected by venepuncture.

  • Analgesia for major abdominal surgery: A feasibility study using a combination of intrathecal and epidural morphine

    Major abdominal surgery is a common procedure associated with significant postoperative pain and morbidity. Poorly controlled pain negatively impacts upon recovery following surgery. Intrathecal morphine is an increasingly popular alternative analgesic option in major abdominal surgery but has a limited duration of effect. Epidural morphine can be continued postoperatively for as long as the epidural catheter remains in situ. A direct comparison of epidural morphine and intravenous opioid PCA following preoperative intrathecal morphine for major abdominal surgery has not been conducted. We believe epidural morphine will be superior to intravenous opioid PCA in terms of quality of recovery, cost saving and opioid-sparing in the context of similar or lower side effects. The results of this preliminary feasibility study will be used to design a large-scale phase III, multicentre trial with the objective of obtaining outcomes that will accurately inform clinical practice

  • Yoga or cognitive behavioural therapy for psychological distress and emotional difficulties: Can our neurophysiology predict treatment efficacy?

    Almost half of all Australians experience a mental health disorder in their lifetime. Consistent with dimensional, transdiagnostic conceptualisations of mental health, many individuals experiencing high levels of psychological distress and emotional difficulties may fall short of formal diagnostic criteria for a mental health disorder yet are in need of psychological intervention. Indeed, these so-called "subclinical" disorders are key predictors of future mental health disorder development and are associated with poorer functioning and lower quality of life. At the same time, the COVID-19 pandemic has increased psychological distress and yet reduced access to gold standard mental health treatment like cognitive behavioural therapy (CBT). A paradigm shift is needed to increase the evidence-base and availability of mental health interventions. A “transdiagnostic” treatment approach where an intervention targets shared processes underlying psychological/emotional distress (e.g., sleep, emotion regulation) rather than disorder-specific symptoms is an innovative way to improve and prevent poor mental health. Individuals with better sleep and emotion regulation have less intense and persistent negative emotions in response to environmental stressors (e.g., pandemics, bushfires, floods), thus protecting against poor mental health. Yoga, a combination of mindfulness meditation, breathwork, and physical postures, is a compelling novel transdiagnostic solution. Yoga is efficacious for prevalent and comorbid mental health disorders associated with high psychological distress among Australians: anxiety, major depressive, posttraumatic stress, and alcohol use disorders. Yoga is also popular and has several advantages over first-line CBT like lower associated stigma and wait times and increased cost-effectiveness. Yoga is proposed to exert positive effects via improved sleep and emotion regulation. This innovative research aims to establish yoga efficacy for psychological/emotional distress (at least subclinical mental health) and to assess if sleep and/or emotion regulation are moderators and/or mediators of mental health outcome. It will use a non-inferiority randomised controlled trial design with CBT as the active control and both subjective (questionnaires, ecological momentary assessment) and objective (actigraphy, heart rate variability) measures of sleep and emotion regulation. This research will bring about a paradigm shift in mental health care and advance precision medicine.

  • A comparison of online and face-to-face Dialectical Behaviour Therapy: A parallel group randomized trial and pragmatic evaluation

    DBT is a programme that has traditionally been delivered face-to-face. That is, people meet face-to-face with a therapist, and attend a skills training group face-to-face for the duration of the programme. People sometimes contact their therapist for coaching by phone. Recently it has become common to offer both individual therapy and skills training online. Our group and other researchers have been exploring the best ways to deliver DBT online to make this very effective programme available to more people. The Australian DBT Institute developed an online DBT programme over five years ago. We have interviewed therapists about their experiences, and most said that online DBT is effective, safe, and most people like it. Some people prefer it to face-to-face DBT. We wish to compare the effectiveness and experience of a full DBT programme delivered face-to-face and online. There has been no research published that has done this.

  • Investigating the effect of fermented dairy on brain structure and function

    The interaction between the human brain and the bacteria within their gastrointestinal tract, otherwise known as the gut microbiome, has been emerging as a major factor in health and wellbeing. Fermented dairy products like yogurt contain “live cultures” of specific types of bacteria that interact with the human gut microbiome and by doing so, maybe potentially beneficial to their brain function, cognitive performance, and mood. To date, research on fermented dairy and brain measures is limited. For this reason, this study is interested in studying the possible impact of fermented dairy on measures of brain function and neurochemistry. This study will compare the possible effects of fermented dairy against a non-fermented dairy drink by measuring several areas of brain function. This study will also investigate possible differences between these groups on antioxidant capacity, cognitive performance, mood, and gut microbiota composition. This study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Forty female participants will complete an 8-week intervention, which will involve two face-to-face visits at the Monash Brain Park, Australia. Participants will be randomly assigned to one of two groups: one receiving a fermented dairy product (intervention) or a matched placebo (n = 20 per group). Findings from this study may be of particular relevance to the many Australians who suffer from depression, anxiety and stress. This research will also enable us to answer an important public health question; are fermented dairy products any better or worse for our health than conventional dairy products? This information will be useful for health professionals and policymakers and may shape future dietary guidelines.

  • Prospective registry for geniculate arterial embolisation as treatment for osteoarthritis and neovascularity.

    Genicular artery embolisation (GAE) or embolisation of the knee is a minimally-invasive procedure used to reduce pain caused by KOA. GAE is a legitimate course of treatment for patients referred by their orthopaedic surgeons who meet the inclusion criteria. A small number of human studies investigating GAE in patients with knee osteoarthritis (KOA) have been conducted in Australia and internationally. We seek to establish a prospective registry on GAE to consolidate local experiences and collect evidence to affirm the safety and efficacy of GAE procedure in patients experiencing moderate-to-severe persistent chronic pain following total knee arthroplasty (TKA) and also those with mild-to-severe knee OA who are not yet suitable for surgical intervention.

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