ANZCTR search results

Sleep and circadian disturbances are intricately linked to the onset, co-morbidity and chronicity of various mental disorders. For instance, shortened or extended sleep duration, increased sleep fragmentation and delayed and disorganized sleep-wake schedules have been observed in young people with a range of affective and psychotic disorders. Increasing evidence suggests that changes in sleep and circadian rhythms may modulate the trajectory of mental disorders and treatment outcomes, but little is currently known about sleep and circadian rhythms during critical mental illness episodes leading to hospitalization and how this may relate to the recovery process. The current observational study will use novel ambulatory devices to monitor sleep, general activity levels, body temperature and ambient light exposure across multiple days in inpatients admitted to a young adult mental health service. Potential associations between sleep-wake and circadian parameters and changes in self-reported clinical symptoms measured across the course of hospitalization will also be investigated. This study has the potential to deepen our understanding of sleep and circadian disturbances in acute phases of mental disorders and how they relate to the recovery process.

In Australia, as in most developed countries, hot beverage scalds are the leading cause of burn injuries in young children. The high incidence of hot beverage scalds make it an important paediatric public health issue, yet is often overlooked in research and injury prevention. Not only are hot beverage scalds painful, they carry a risk of lifelong psychological stress and physical scarring. As well as the physical and emotional consequences, the associated financial costs of managing these injuries on the healthcare system are also substantial. Therefore, developing targeted prevention strategies to reduce these injuries are essential. The aim of this project is to develop an awareness and prevention program specifically targeting mothers of children aged 5 to 12 months using an App-based ‘gamified’ platform. Mothers will receive messages about hot drink scald risk factors associated with their child’s age and developmental stage, and the correct burn first aid treatment. The potential benefits of this intervention include: - Increased awareness among mothers of young children about the risks, severity and frequency of hot beverage scald injuries. - Reduction in both the incidence of hot beverage scalds among young children, and the long-term physical and psychological impact of these injuries on the child, family and community. - Reduction in health care costs and burden on health system. - Potential for campaign to be rolled out in other regions and states. By increasing mothers' awareness of the frequency and severity of hot beverage scalds, and providing them with regular age-relevant messages of the potential risk factors, they will be better equipped to take preventative measures, and provide the correct first aid in the event of a scald occurring to minimise injury severity. This study will use ‘gamification’ techniques (rewarding participants for involvement) in an awareness and prevention program. Innovative new technologies such as Smartphone applications (apps) present a novel way for delivering individual-level injury prevention messages. Smartphone ownership goes beyond socio-economic status boundaries. One of the latest methods being used in health-related apps aimed at behaviour change is gamification. Gamification is “applying game mechanics and game design techniques in a non-game context in order to engage and influence people’s beliefs, attitudes & behaviours”. Although there are a multitude of health related apps currently available for chronic disease management, smoking cessation, weight loss etc, to date there has been no research into the efficacy of using gamification in injury prevention interventions.

To our knowledge no study investigated serum ketone levels in Gestational Diabetes Mellitus (GDM) pregnancy with a modestly lower carbohydrate diet. Our primary aim is to document a range of blood ketone in women on a routine GDM diet (180-200 g carbohydrates/day) and a modestly lower carbohydrate diet (135g carbohydrates/day). The 135 g of carbohydrate/day is an absolute amount of carbohydrate which is in line with Institute of Medicine (IOM) recommendation for carbohydrate intake during pregnancy. We also aim to examine the effect of modestly lower carbohydrate diet on the risk of ketonemia in GDM pregnancy. We hypothesise that when compared to a routine GDM diet, a modestly lower carbohydrate diet will not increase ketone levels in GDM pregnancy, nor will it increase the risk of adverse pregnancy outcomes including risk of large/small gestational age babies and caesarean delivery. If our hypotheses are proven to be correct, perhaps prescribing a modestly lower carbohydrate diet to no less than 135g/day will be the new standard for treatment of GDM.

Aims and research design The aim of this pilot study is to assess the feasibility of a randomised controlled trial aimed to improve sleep of patients with low back pain, using a hypnotic drug called Zopiclone, which is a currently available drug approved by the Therapeutic Goods Administration. Methods In accordance with recommendations for pilot studies this pilot will recruit thirty-two participants. Participants will have acute low back pain and a co-existing sleep disturbance. Participants will be randomly allocated to one of two study groups of equal sizes. Patients in both groups will be encouraged to continue with their usual care, one group will receive placebo, while the other group also will receive Zopiclone over the course of 14 days. Procedure Participants who have sleep apnoea or severe insomnia will be excluded. As this is a pilot study the primary aim of this study is to use the data obtained to refine recruitment, outcome measures and randomisation procedures for a larger trial. A secondary aim of this study is to estimate the effect of managed sleep on acute low back pain from the 95% confidence intervals. There have been no other studies to date that have evaluated the feasibility of controlling sleep as a way of improving low back pain. As this is a feasibility study the primary outcome measure has not yet been defined. The participants will be asked to complete a Pittsburgh Sleep diary and a numeric rating scale (NRS) to rate their average pain intensity daily for the first 14 days. During this time participants will be asked to wear an actiwatch overnight. The actiwatch measures movement during sleep and therefore it is an indirect measure of sleep quality. Participants will be asked to complete a Low back screening questionnaire and Global perception of change scale. These measures were selected because they are widely employed to assess persistence in low back pain. Psychological factors including depression and anxiety will be measured using the DASS. Participants will also be asked to rate next day effects using a Flinders fatigue scale and an Epsworth sleepiness scale. Conclusion. This trial aims to conclude whether or not it is feasible to do a large scale randomised placebo controlled trial.

The aim of this study is to investigate the efficacy of pregabalin against headache resulting from unintentional dural puncture in obstetric patients having epidural analgesia for labour and delivery. The primary question addressed is “Does pregabalin reduce the severity of post-dural puncture headache in postpartum women after unintentional dural puncture?” Our hypothesis is that oral pregabalin will significantly reduce the severity of post-dural puncture headache in postpartum women experiencing the complication of unintentional dural puncture. The question is addressed by conduct of a randomized, double-blind, placebo-controlled, parallel-group, superiority clinical trial. The study drugs will be commenced after unintentional dural puncture and patients followed for one week, with the incidence and severity of headache important outcomes showing whether pregablin is effective compared with a placebo.

People with schizophrenia can experience difficulties with attention, concentration and memory; these are referred to as cognitive symptoms. There are currently no effective treatments for these symptoms. We are investigating whether non-invasive brain stimulation, specifically transcranial Direct Current Stimulation (tDCS), is able to improve cognition in individuals with schizophrenia.

Hypothermia is a known adverse effect of general and regional anaesthesia. It is associated with increased risk of complications including surgical site infections and bleeding. For this reason, it is recommended that strategies are implemented to prevent hypothermia. The most effective strategy is forced-air warming. Of note, with advances in medical technology continuing to expand the indications for minimally invasive surgical techniques, sedation is likely to be increasingly used for many procedures that once could only be performed with general anaesthesia. Interventions to prevent hypothermia from occurring, such as forced air warming, are not currently used for sedated patients. Yet, we recently observed in one of our previous studies that about one quarter of patients undergoing procedures with sedation were hypothermic after their procedure. Sedated patients who become hypothermic may be at similar risk of developing complications, like infections and bleeding, to those patients who undergo a general or regional anaesthetic. As such, investigation of the clinical benefits of preventing hypothermia in sedated patients is required. This research aims to determine whether forced air warming reduces hypothermia in sedated patients. The results could potentially benefit the large number of patients undergoing interventional procedures with sedation.

Lauricidin is an over-the-counter wellness agent, the active ingredient of which is glycerol monolaurate (GML), a naturally occurring inhibitor of production of a bacterial enzyme (a lipase) which breaks down lipids (fats). GML is found in coconut, milk and other foods and is classed by the FDA as Generally Regarded as Safe (GRAS). Lauricidin is sold as a skin cream containing 1% glycerol monolaurate. The purpose of this study is to determine the ocular safety (as measured by ocular redness, ocular staining and discomfort) of lauricidin moisturising cream in a normal population when applied around the eyelids, and the efficacy of the cream when used by dry eye disease participants for the treatment of dry eye. Efficacy will be determined using a number of clinical measures comprising Ocular Surface Disease index (OSDI) score, tear break up time and collection of bacteria from the eyelid using lid swabs. Our hypotheses are that there will be no difference between lauricidin moisturising cream and petrolatum for eye redness, corneal staining and ocular symptoms during the safety phase and OSDI score, tear break up time and lid swabs during the efficacy phase.

The project is a naturalistic observational study of individualised Western herbal medicine in a naturopathic practice setting. This project will explore the effectiveness of individualised herbal medicine prescriptions in self-reported anxiety and depressions, using a whole practice framework. This approach will not only help to evaluate total herbal medicine practice as it is practised – rather than evaluate individual herbal medicines in specific conditions in a manner which does not reflect practice – but will also help to develop research capacity on the herbal practitioner community, who will be involved in the study.

The main aim of this study is to see whether pentosan polysulfate sodium (PPS) is safe and effective in treating Bone Marrow Oedema Lesion (BML) associated with acute knee injury and thereby relieving the pain caused by BML. Every person who participates in this study will receive a course of PPS injections.