ANZCTR search results

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.

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

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.

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.

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.

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.

This research involves participants with a diagnosis of anorexia nervosa receiving narrative therapy intervention (as per a manualised treatment developed by Dr Janet Conti) on a weekly basis for approximately 40 sessions. The treatment is facilitated at the Western Sydney University Psychology psychology rooms or over telehealth programs if required. Upon individuals expressing their interest in the intervention, participants were screened according to the inclusion/exclusion criteria and contacted via e-mail to advise of their acceptance to the intervention, request any further information, and to provide recruitment documentation and informed consent forms. Potential participants had approximately 2-3 weeks to consider participation and confirm their desire to proceed. During these 2-3 weeks, participants completed baseline quantitative measures. Following this, clearance was obtained from the participant's GP and contact made via e-mail or telephone prior to, at the outset, during, and at the end point of treatment. Participants received the intervention free of charge. They are asked to complete surveys and questionnaires at the beginning, middle and end points of treatment. They are provided with a two-page summary of the findings at the end of the intervention. Additionally, participants will be actively involved in member-checking the analysis of session and treatment outcomes to ensure that their feedback, experiences and perspectives have been accurately represented in the final paper.

The COVID-19 (coronavirus) pandemic has led to a large amount of information being made available to the community through a range of mediums. How this information is presented can have a different effect on different people in terms of how much the accept it, and how much it may influence their future behaviours. This research seeks to compare the effectiveness of different approaches that can be used to convey COVID-19 health messages. This will better inform government strategies as to how they might share COVID-19 information as well as information relevant to other future health issues in our community. Using both the 6 vulnerable subgroup populations as well as the community sample group, this study aims to assess: a) the interaction effects between direct information provision versus conversational information provision and how this differs between population groups as well as across the contexts.

Diabetes mellitus affects an estimated 451 million adults worldwide, and costs health systems US$850 billion annually. A cornerstone of effective diabetes management is maintaining optimum blood glucose control. However, less than half of people with diabetes reach their target ranges for blood glucose control. A relatively safe and low-cost therapy that is emerging as a promising treatment for diabetes is Olive Leaf Extract (OLE). While findings from laboratory studies indicate OLE may act on multiple metabolic pathways to improve blood glucose control, robust clinical research is needed in order to support the use of OLE in clinical practice. Researchers from the National Centre for Naturopathic Medicine (at Southern Cross University) and Torrens University Australia are embarking on a ground-breaking study to generate this much-needed evidence. The 6-month clinical study will explore whether OLE is safe and effective at improving blood glucose control, diabetes-related distress and quality of life, in adults living with type 2 diabetes. If OLE is shown to be a suitable treatment for diabetes, it may help support individuals living with the condition to reach their blood glucose targets, and in turn, help reduce the impact of diabetes on their lives.

Following surgery for weight loss, the size of the stomach is considerably reduced and food passes through to the small intestines faster. When food passes through the small intestines, various ‘hormones’ that are thought to assist with weight loss enter the bloodstream. While this seems to be a useful effect, some may experience complications such as having a low blood sugar level (post-bariatric hypoglycaemia) or low blood pressure (post-prandial hypotension) after eating and we think this may happen due to increased production of these ‘hormones’. Currently, the treatment options for these conditions are limited. One of the more common types of weight loss surgery is called the Roux-en-Y gastric bypass. From previous studies, one particular hormone called glucagon-like peptide-1 has been consistently found to be elevated following a meal post-surgery and it is elevated to a greater extent in patients with post-bariatric hypoglycaemia. More recently, a newer surgical technique called the one anastomosis gastric bypass has been developed, however, we do not know whether the rate of passage of food and the hormonal changes occur to a similar extent as with the Roux-en-Y gastric bypass. This study will follow up on participants before and after surgery and we will analyse how hormonal profiles and how the speed of the passage of food changes. We will be able to compare the effects of Roux-en-Y gastric bypass and one anastomosis gastric bypass surgery. This understanding may assist in the development of newer therapies for post-bariatric hypoglycaemia and post-prandial hypotension.