ANZCTR search results

Symptoms of insomnia are common for women in the perinatal period. A primary precipitating factor for postpartum insomnia is infant nocturnal awakenings. As women cope with these significant sleep disruptions, they may also develop unhelpful sleep-related cognitions/behaviours, which can perpetuate sleep problems well into the postpartum period. Therefore, (a) infant sleep as a precipitator, and (b) maternal sleep-related cognitions and behaviours as perpetuators are sound therapeutic targets for reducing and preventing insomnia in perinatal women. The primary aim (Aim 1) is to examine whether reducing exposure to a major precipitator of postpartum insomnia by increasing infant sleep continuity and duration from 0-6 months, lowers symptoms of postpartum insomnia in first-time mothers who are at risk for insomnia. It is predicted that compared to controls, women receiving the infant sleep intervention will report better sleep and wellbeing. The secondary aim (Aim 2) is exploratory. It examines how two interventions, one addressing infant sleep, the other targeting maternal sleep-related cognition/behaviours, might ameliorate the development of postpartum insomnia. Participants, 114 mother-and-infant dyads recruited during pregnancy (N = 228), will be randomised into 1 of 3 conditions: (a) an infant sleep intervention, (b) a maternal sleep intervention, and (c) a control condition. Infant sleep intervention participants will receive a bassinet that uses noise and ‘rocking’ motions to boost infant sleep. The maternal sleep intervention is based on Cognitive Behavioural Therapy for Insomnia (CBT-I), and is delivered at 6 stages: 30 and 35 weeks pregnancy, then 2 weeks, 2 months, 3 months, and 6 months postpartum. The control group will receive sleep information at 26-32 weeks pregnancy. Outcome measures of sleep and wellbeing will be collected at 30 and 35 weeks pregnancy, and 2, 6, and 12 months postpartum.

This project will address the complex issue of the use of headgear for the prevention of sports concussion in junior Australian Rules football. Specifically, we will explore injury rates and on-field player behaviour in a repeated-measures study design. Players will be asked to wear headgear for half the match (and not wear headgear for the other half) for five matches during their regular season to facilitate comparison of injury rates and on-field behaviour with and without headgear.

This study will explore the feasibility and potential benefit of providing early vocational rehabilitation following a stroke. Participants will be n=54 males and females, all aged over 18 who have been admitted to inpatient rehabilitation with new stroke (all severities) and who were working (including self-employed, paid or unpaid) prior to their stroke. Participants will be recruited from all rehabilitation services across Alfred Health, including in-hospital, home-based and community rehabilitation. Researchers will liaise with clinicians to identify eligible participants for the study, and the research assistant will undertake the informed consent process. Following participant consent, participants will be randomised to either the usual care (control) or intervention group. Participants in the intervention group will receive 'Early Vocational Rehabilitation' for 12 weeks, delivered by a stroke specialist occupational therapist (in addition to usual clinical rehabilitation). The experimental intervention will be tailored to the needs of the individual participant. The control group will receive usual clinical rehabilitation only.

A randomised, double-blinded study to determine if the application of Mi-Gel to the vulvar vestibule results in reduced impact of pain compared to placebo in patients with entry dyspareunia.

PolyNovo Biomaterials Pty Ltd has developed a new medical device, NovoSorb® Biodegradable Temporising Matrix (BTM), BTM is a skin substitute used to treat patients who need their wounds to be covered after an injury such as a deep burn, an accident where the skin has been damaged, or a severe skin infection. This study will assess the long-term safety and performance in patients where BTM was applied to at least 5% of their body at least 18 months ago. Patients will be asked to return to their hospital where a surgeon will examine them to assess their current health. Areas of the body where BTM was applied will also be examined by the surgeon. Patients will also assess the areas treated with BTM.

In this study, we aim to use eyelid movement data collected from a commercial system from Optalert (Optalert Australia Pty Ltd, Melbourne, Australia) in patients with seizures in order to develop models to detect, predict and classify seizures. The device records eyelid and eye movements using an infrared light emitting diode located on a pair of light weight glasses frames. Participants admitted for inpatient video-EEG monitoring across the combined Comprehensive Epilepsy Program at The Alfred Hospital and The Royal Melbourne Hospital will be invited to participate in the study. Participants will wear the glasses during wakefulness throughout the monitoring period, which typically lasts five days. Once the seizure annotations and associated eyelid movements are collected, machine learning shall be used to determine if there is a digital biomarker that can be used to: 1. predict the onset of a seizure, 2. identify the occurrence of a seizure 3. classify the nature of the seizure.

Veno-arterial extra corporeal membrane oxygenation (VA-ECMO) involves the use of a machine that performs the function of the heart and lung. It is occasionally required after open heart surgery as a means of providing life-saving, temporary support of organ function if other strategies to support organ function are not working. There is little data about outcomes after such a strategy in the Australian context. This observational study based on historical data from patients who required VA-ECMO after cardiac surgery seeks to describe the 30 day outcomes for these patients. Furthermore, modelling will be performed on the data to determine if there are risk factors that can predict survival.

MVP is a common clinical diagnosis. Whilst the majority of patients with MVP have a benign prognosis, increased rates of arrhythmias and sudden cardiac death have been reported in some patients with MVP. This observational study will attempt to assess whether patients with MVP are at higher risk of ventricular arrhythmias or sudden death compared to a control cohort. Patients (study group and control group 1) will be recruited after initial echocardiography has identified the presence of mitral valve prolapse and will undergo continuous cardiac rhythm monitoring with an implantable loop recorder. They be followed up for a minimum of 3 months. The patients for control group will be patients who have an ILR inserted for clinical reasons. The primary outcome will be identification of ILR detected ventricular arrhythmias.

Early childhood education and care (ECEC) is a promising setting for interventions targeting children’s nutrition behaviours. Web-based modalities may be a promising way of delivering childcare-based interventions whilst overcoming some of the challenges of previous approaches. As such, the primary aim of this study is to examine the impact of a web-based intervention together with health promotion officer support targeting childcare centre healthy eating practices on improving child dietary intake of fruit and vegetable serves in childcare. The intervention will target staff within childcare centres and support their implementation of healthy eating practices.

The purpose of this study is to see if a handheld imaging device (MEprobe) can accurately detect the microscopic presence of cancer in breast surgery patients. Who is it for? You may be eligible for this study if you are female, aged 18 or over and have been diagnosed with an invasive or localized breast cancer. Study details All Participants in this study will have a surgical probe take images of the breast tissue during their breast surgery. Your breast surgeon will also send the breast tissue removed during surgery to pathology for routine laboratory testing to determine the characteristics of the breast cancer (including the size of the cancer as well as diagnostic factors such as tumour margins and hormone receptor status). The images from the device will be assessed by a reading centre following the procedure, to ascertain the accuracy of the probe acquired images. The images from the device will not be used to make any treatment decisions. It is hoped this research will demonstrate that surgical imaging incorporated into the MEprobe is capable of creating high quality images that can be used during breast surgery to identify residual breast cancer and guide future protocols using this device.