ANZCTR search results

The aim of this randomised control trial is to evaluate the efficacy of a lunchbox program on the nutritional content of student lunchboxes. The program will run for approximately 10 weeks. Ten primary schools in the Hunter New England, Central Coast and Mid North Coast regions of NSW will be randomly allocated to one of two intervention arms or a waitlist control group. The program aims to support parents/carers to swap what is packed in lunchboxes from sometimes to everyday food, through the use of weekly support messages delivered through a school communication app, with or without additional support.

The purpose of the study is to determine if a strength-focused exercise program prior to surgery can improve participant’s physical function, reduce time in hospital and complications from surgery, and help restore physical function and quality of life post-surgery. Who is it for? You may be eligible for this study if you are an adult who is having surgery due to head and neck cancer at Fiona Stanley Hospital in Western Australia. Study details Participants in this study will receive one of three different treatments: 1. A ‘pre-habilitation’ exercise program, involving a strength and aerobic exercise program prior to surgery. Participants in this group will also receive an education program. 2. The same pre-habilitation program as group 1, plus an additional 6-week post-surgery rehabilitation program. 3. Usual care including an education program, and routine post-operative care. Participants in this study will be randomly allocated to one of these treatment groups, and will also need to complete a battery of physical function tests including a timed up and go test, grip strength, step test and DEXA scan. You will also need to complete a number of self reported questionnaires relating to your quality of life, quality of recovery and functional ability. It is hoped that this research will help determine if a pre-habiltiation program is effective at improving post-surgery outcomes in head and neck cancer patients.

Accurate quantification and analysis of jumping and landing technique is one method to improve sport performance. The current gold-standard method for quantifying movement is three-dimensional biomechanical analysis in a motion analysis laboratory. However, due to financial, time, and logistical constraints, this method is frequently inaccessible to the wider sporting population. Wearable inertial measurement units (IMU) – consisting of micro-sensors– have been used as a cost-effective, accessible option that can provide real-time feedback of performance. To further promote wearable IMU use, it is important to evaluate the validity and reliability compared to the previously established method of motion analysis – three-dimensional biomechanical analysis. Study hypothesis: that wearable IMUs are a valid and reliable alternative to quantifying jumping and landing movements compared to three-dimensional biomechanical analysis.

The purpose of this study is to see if melatonin supplementation can help improve sleep in women receiving hormone blocking therapy for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have stage 1-3 breast cancer, are taking hormone blocking therapy and have trouble sleeping. Study details Participants in this study will be randomised by chance into two groups. One group will take melatonin tablets every evening before bed for 12 weeks. The other group will take a placebo tablet every evening before bed for 12 weeks. Neither the participants nor the researchers will know which participants are taking which tablets. All participants will complete questionnaires, complete a medication diary and wear an atigraph watch to measure your sleep. It is hoped this research will demonstrate the usefulness of melatonin in improving sleep in breast cancer patients.

Considering the dearth of research in VR augmented mindfulness in general, and in the use of VR for the management of pain, it is necessary first to trial the training in healthy controls. Therefore, the aim of this study is to generate data on the feasibility and acceptability of VR-augmented mindfulness. We will test the relative efficacy of VR-augmented mindfulness, compared to mindfulness without VR augmentation, an experience of the VR environment without the mindfulness instruction (VR only) and a natural history control (tested with no training). These conditions will be well matched in terms of using the same audiotape (mindfulness and VR-augmented mindfulness) and the same VR scenes (VR-augmented mindfulness and VR-only). This would allow us to generate data on the effect sizes of VR-augmented mindfulness vs mindfulness; and VR-augmented mindfulness vs VR-only on which to power a definitive clinical trial. We hypothesize that VR-augmented mindfulness will be acceptable, feasible and associated with larger effects than mindfulness alone, and that the VR-only group will find the condition credible, but less effective than the two active training groups.

This study aims to evaluate two pain relief medications, oxycodone/naloxone prolonged-release (OXN PR) and oxycodone alone prolonged-release (Oxy PR). The study will assess how effective these medications are at relieving pain and reducing constipation in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have metastatic cancer (Stage IV) and moderate to severe pain. Study details All participants will be randomly assigned (by chance) to either receive a combination drug of oxycodone/naloxone or oxycodone alone. In both groups participants will take two tablets a day, however this dosage may be adjusted if needed by your treating clinician. The study will involve a variety of questionnaires exploring Pain, Quality of life and Bowel movement over a 5 week period initially and if you decide to continue on the study for a total of 11 weeks. It is hoped this study can provide insight into the clinical effectiveness between the two pain medications and their effect on sustained analgesia and bowel function. This study may provide greater knowledge into how pain is treated in patients with advanced cancer.

Mild traumatic brain injury (mTBI) is a common problem, crossing all socioeconomic circumstances and age groups. In children and young adults, concussions account for 90% of all traumatic brain injuries, with one in five children experiencing a concussion by the age of 10 years. Post-concussion syndrome (PCS) is a collection of symptoms including physical (i.e., headaches, dizziness), cognitive (i.e., difficulties with attention, and memory), and behavioural (i.e., sleep difficulties, depression, anxiety) symptoms. Most children have recovered from their concussion injury within a month, but 11% continue to experience symptoms at three or more months, with 2% still having symptoms at twelve months or longer. Multiple clinical practice guidelines and position statements exist to guide the management of concussion in children but have information gaps in the provision of discharge advice and continuation of care. The benefits of clear and consistent discharge information and routine follow-up care are known, but practice variation occurs in clinical settings. This purpose of this research is to adapt clinical pathways to be used in local ambulatory care settings. Clinical pathways tools will include discharge Fact Sheets and eHealth applications. A prospective study of clinical and process centred outcomes prior to implementation of the amended clinical pathway will be performed, followed by an evaluation of the clinical pathway post-intervention. It is hoped that this research will improve follow-up care for children after a concussion injury including facilitating those with ongoing symptoms to seek appropriate care.

This is a sub-study of the SHINE randomised controlled trial (ACTRN12618001498280). In this sub-study, we will also monitor oxygen supply to the brain (by placing a sensor on the forehead). We hope that this will give further information about the changes in oxygen delivery to the brain during placement of breathing tube for babies.

Internationally stroke ranks second among all causes of disability and is adding to considerable worldwide healthcare burden. Over the last 5 years a new procedure to remove clots (Endovascular Thrombectomy - EVT) has been effective for the treatment of acute large strokes, with significant reductions in long term patient disability compared to standard treatment. However, there minimal guidance on blood pressure management during the procedure. The brain is especially vulnerable to low blood pressure during the acute stroke period due to low blood supply, impairment of how the brain regulates blood flow and further falls in blood flow to the brain. High blood pressure may be beneficial due to increased blood flow in areas at risk during this time. It could be harmful due to brain injury process, swelling, and bleeding into the brain. Conversely, relatively low blood pressure could be harmful. Current evidence is limited to large observational studies. This randomised controlled study will examine the safety and efficacy of two systolic blood pressures (SBP) management arms during general anaesthesia for EVT on outcomes in patients with acute ischaemic stroke.

The aim of this project is to determine the feasibility of running a fully-powered randomised controlled trial on the use of high intensity exercise in reducing period pain (dysmenorrhoea). This project will use 30 women aged 18-30 who have primary dysmenorrhoea (period pain not explained by an identifiable pathology). Women will be randomly allocated to an 'Exercise' group or 'Wait-list Control' group. Women in the 'Exercise' group will undertake four high intensity exercise classes per week for 12 weeks total. Both groups will complete a Menstrual Pain Diary during each menstrual period over the 12 weeks. Other outcome measures will include pelvic and period pain scales, anthropometric measurements, fitness level, exercise compliance, analgesic use over the 12 weeks, and any adverse events experienced. These outcomes will assist in determining the feasibility of an appropriately-powered RCT to explore the effectiveness of high intensity exercise on primary dysmenorrhoea.