ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Eggs Over Easy: Effects of egg consumption on blood vitamin D levels in young adults.

    The aim of this 12-week study is to compare the effectiveness of consuming 2, 7 and 12 eggs per week during the winter-spring months on serum (blood) vitamin D levels in adults aged 25-40 years who are at risk of low vitamin D status. This design will determine whether there is a dose-response relationship between egg consumption and vitamin D levels, and to help assess if there is an optimal number of eggs required to maintain vitamin D status during the winter-spring months. We hypothesize that there will be a linear dose-relationship between egg consumption and vitamin D levels, and that the consumption of 7 eggs per week (equivalent to a weekly vitamin D dose of approx. 1150 IU) will maintain vitamin D levels relative to the low egg group who will experience a wintertime decline, whereas consumption of 12 eggs per week (equivalent to a weekly vitamin D dose of approx. 2000 IU) will be effective to increase vitamin D levels after 12 weeks.

  • Recognising and managing fatigue after brain injury

    A mixed methods study. A randomised controlled trial with 78 participants adult inpatients with severe acquired brain injury; 40 allocated to routine usual care and 38 to four group therapy sessions over two weeks run by an experienced Occupational Therapist. Outcome measures were collected at baseline and at the completion of the therapy (Barrow Neurological Institute Fatigue Scale, Quality of Life after Brain Injury questionnaire and a Fatigue Knowledge questionnaire assessing knowledge related to the aims of the education modules). Ten patients were interviewed to discuss their fatigue journey and impressions of receiving fatigue management therapy in a group.

  • Intraperitoneal instillation of Ropivacaine at gynaecological laparoscopy: a randomised control trial

    Pain after surgery can impact your recovery and there has been a lot of research into what we can do to improve your pain. After a laparoscopy for a hysterectomy or endometriosis, you would normally have regular paracetamol and an anti-inflammatory called diclofenac, and some opioid medication called oxycodone for when your pain is particularly bad. We are conducting a trial to determine whether placing some local anaesthetic in the pelvis at the end of your laparoscopic hysterectomy or excision of endometriosis can improve your pain in the first 24 hours after surgery, in addition to the standard medications that you would use for pain. Approximately 100 women will be involved in the study. You will be randomly allocated to either receiving the local anaesthetic, or receiving a placebo (something that looks exactly like the local anaesthetic but doesn’t have any medicine in it). Neither we, as your doctors, or you will know which allocation you receive, and we cannot decide which allocation you receive if you agree to take part in the study. After your surgery, we will ask you to tell us about your pain using what is called a ‘visual analogue scale’ at 1, 4, 8 and 24 hrs postoperative. You will need to fill in a paper questionnaire at home. We will also ask you to record how much pain relief you need during the first 8, 24 and 72 hrs. This form can either be emailed or posted back to us via the envelope provided. A member of the research team will call you at 72 hrs and 2 weeks postoperative to evaluate for any complications. We will be conducting the study at the Townsville University Hospital and the Mater Hospital in Pimlico.

  • Towards best practice in the delivery of prescribed exercise via Telehealth for individuals diagnosed with cancer undergoing active treatment.

    The purpose of this study is to explore the pitfalls and showcase best practices of using telehealth to provide exercise to cancer patients, and explore whether results are comparable to face-to-face delivery of exercise. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer. Study details Participants in this study will randomly receive one of two treatments: 1. An 8-week exercise program, where participants will join an online Zoom group teleconference and complete exercises as prescribed by the study team. 2. Physical and online copies of the current Australian Guidelines for Physical Activity. It is hoped that this research will help to determine whether the use of telehealth is beneficial to cancer patients and whether it is a useful alternative option to face-to-face exercise therapy. Note: this brief summary is intended for lay audience.

  • Optimising Health in Women across Pre-Pregnancy, Pregnancy & Post-Birth.

    Overweight/obesity is a National Health Priority and women of reproductive age are at greatest risk with a high rate of weight gain and increasing proportions entering pregnancy overweight (>30%) or obese (20%). Once pregnant, 60% have excessive gestational weight gain (GWG) and 65% retain weight postpartum. Simple lifestyle interventions can prevent weight gain and related complications for improved health. Here we aim to adapt and diversify an evidence based lifestyle intervention to optimise healthy weight and modifiable lifestyle behaviours across preconception, pregnancy and postpartum life stages. Utilising a novel design we will recruit women preconception that have signalled pregnancy intention by joining or upgrading their private health insurance to include Obstetrics cover via our funding partner Medibank Private. Women will receive 3 healthy lifestyle modules across preconception, pregnancy and postpartum, delivered via an online platform with ongoing support provided. Outcomes will include improved preconception health knowledge and risk perception, optimised weight gain in pregnancy and limited postpartum weight retention.

  • Promoting Resilience in Nurses: evaluating the impacts of a workplace resilience program on mental health nurse wellbeing

    This project aims to improve mental health nurses’ resilience, retention and quality of practice through implementation of a resilience-building program. There is a critical national shortage of nurses in mental health, and attrition of the mental health nursing workforce is due in large part to workplace stressors. Using a randomised controlled trial design, the study will compare outcomes for mental health nurses who participate in the resilience program with a group of nurses who do not. The anticipated outcomes are improved nurse resilience, turnover intention, and quality of nursing practice, and reduced negative psychological impacts of workplace stress.

  • Remote blood pressure monitoring in high risk pregnancy – a randomised controlled trial (REMOTE CONTROL trial)

    Hypertension is one of the most common complications of pregnancy, affecting 2-10% of pregnant women. It is associated with adverse maternal and fetal outcomes, such as eclampsia, stroke, fetal growth restriction and stillbirth. Maternal mortality approaches 15% globally. Monitoring, early recognition and treatment are key to reducing severe complications and mortality. Traditionally in pregnancy, blood pressure (BP) is monitored routinely at outpatient visits. However, major recent events - the Australian bushfires and the COVID-19 pandemic, limited social movement, and therefore initiated major change to antenatal healthcare delivery. There was widespread uptake of Telehealth services and home monitoring of BP. Patients are recording their own BP, directed by a healthcare professional on the frequency of monitoring, and given criteria as to when to attend the hospital. In non-pregnant populations, ambulatory and home BP measurements have been shown to have a closer association with long-term health effects, compared to clinic BP measurements. This is reflected in international guidelines, such as the American Heart Association, and the European Society of Hypertension guidelines, which emphasises the importance of BP self-monitoring. However, this practice is not validated in the pregnant population, and the effect on maternal and fetal outcomes has not been quantified. Our study is a multi-centre, cluster randomised controlled trial investigating antenatal home-based blood pressure monitoring when compared with usual care, through exploring maternal and perinatal outcomes, cost-effectiveness, compliance and qualitative patient satisfaction data. Home BP monitoring could provide more accurate data for clinicians to use in management strategies, thereby reducing poor fetal and maternal outcomes, and the burden of multiple clinic visits. Additionally, home-based monitoring would be useful in future events that would require our population to limit social movement, such as in bushfires and health pandemics.

  • Muscle Relaxation and Endotracheal Intubation: Textbook or Evidence Based? (Relaxed Study)

    When patients undergo surgery with general anaesthesia, the anaesthetist places a plastic tube into the windpipe after the patient is put into sleep. At this time, deep muscle relaxation is required to prevent some bad reflex responses to this procedure, such as coughing and bulking on the tube. However, in daily practice it is not practical to monitor every patient so closely who receives the muscle relaxant drugs, especially during the anaesthetic induction period when the tube is placed into the windpipe after patient is anaesthetized, as this is the most intense and stressful period for the anaesthetist. As such, a majority of anaesthetists routinely use the standard dose of the relaxant drugs and place the tube into the windpipe at the set time point according to the drugs’ respective “product information”. Such practice works for most patients, but some patients may have different sensitivity to the muscle relaxant drugs, and thus it may take longer time than normal to have deep muscle relaxation. This time lag may result in the tube being placed into the windpipe too early and thus cause some unwanted body reactions. These reactions may be very bad for certain patients, for example, if the patient has existing high blood pressure. In order to prevent such premature placement of the windpipe tube, we need to first find out how bad the problem is, i.e., how prevalent the premature placement of the windpipe tube is during standard anaesthetics induction, this is measured by a digital peripheral nerve stimulator, quantifying the degree of muscle relaxation. The good time to place the tube into the windpipe is when none of the four twitches appear on Train-Of-Four (TOF) stimulation of a nerve stimulator, applied to the patient's wrist before anaesthesia. The prevalence of premature placement of the windpipe tube is determined by the percentage of patients whose tube is placed before the disappearance of TOF on the nerve stimulator. This is what our study aims to do and only after we have determined the problem's prevalence, we will then be able to make recommendations accordingly so that we can modify and improve our patient care.

  • Micronutrient intake from enteral nutrition in critically ill adult patients

    When people are critically ill and require treatment in an Intensive Care Unit, they are often unable to eat food. In this situation the standard treatment is to supply them with food dripped into their stomach or bowel through a feeding tube (termed enteral nutrition). Enteral nutrition provides both macronutrients (carbohydrates, protein and fat) and micronutrients (vitamins, minerals and trace elements). In Australia, enteral nutrition formula composition is guided by the National Health and Medical Research Council (NHMRC). These standards, termed Nutrient Reference Values (NRVs), include the recommended dietary intake (RDI), adequate intake (AI) and upper level of intake (UL). However, there is very little information on the amount of micronutrients delivered to critically ill patients during Intensive Care Unit admission. We are conducting a retrospective observational study to assist in determining the micronutrient intake of vitamins B12, D, C, A, iron, folate, thiamine, zinc, and selenium delivered from enteral nutrition to critically ill adults admitted to Box Hill Hospital Intensive Care Unit (ICU), Melbourne, Australia between January 2018 and January 2020. Micronutrient intake will be assessed for the first seven days of ICU admission and compared to Australian NRVs.

  • An evaluation of a Mindfulness and Goal Setting Quality of Life Program and Questionnaire

    The purpose of the project is to compare the well-being effects of a mindfulness training program versus a mindfulness and goal setting program. Subjects will be randomly allocated to one of the two conditions and there will be a maximum of 60 people per course. Condition 1 is a 2-day version of the mindfulness training section of the previously tested Mindfulness-based Quality of Life and Well-Being Program. Participants will be introduced to general mindfulness theory and principles before being taught techniques and exercises such as progressive muscle relaxation, neutral observation of the breath and present moment awareness. Condition 2 is the full 2-day Mindfulness-based Quality of Life and Well-Being Program which teaches mindfulness and goal setting. In addition to 1 day of mindfulness training, participants will be trained for 1 day in the theory and methods of goal setting applied to major quality of life domains (relationships, work, money, health and leisure). Individuals will be given assessments at the beginning and end of the 2-day workshops, and at 4 weeks follow up.

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