ANZCTR search results

This research aims to identify whether individuals currently living in a Queensland Health Community Care Unit (CCU) and who have a diagnosed psychiatric disability (Schizophrenia), maximize their recovery during rehabilitation for discharge and successful community living. Galletly et al. (2016) points out that social and economic costs for “individuals living with a diagnosis of schizophrenia is associated with a greater burden of long­term disability more so than any other mental disorder”. Individuals continue to face social exclusion, experience high levels of economic poverty, unemployment, homelessness and declining physical health (Sawyer & Savy 2014). The purpose of admission to a psychiatric rehabilitation service is to address not only psychological distress but improve recovery and social functioning outcomes. Social Cognition Interaction Training (SCIT) (Roberts, Penn & Combs (2016) is a group based psychotherapy targeting social cognition (SC) deficits which has been identified as a hallmark of schizophrenia. Green et al (2008) defines SC as the "mental operations that underlie social interactions". There are four core domains, emotional processing (perceiving and displaying emotions), theory of mind (ToM, the ability to represent the mental states of others), social perception (decoding and interpreting social cues in others)and attributional style (the way individuals explain the causes and or make sense, of social events or interactions)(Pinkham et al 2014). Trialing SCIT at CCU enhances the existing psychiatric rehabilitation program to provide the individual with opportunity to expand their recovery. SCIT targets visual and vocal perception of emotion in others, difficulties interpreting and inferring others ambiguity during conversation, identifies jumping to conclusions occurs from the attribution of subjective bias and learning to make better guesses by obtaining more information (Roberts & Penn (2009). The ability to construct representations of the relations between oneself and others, and to use those representations flexibly to guide social behaviors (Adolphs cited in Galletly et al. 2016) for improved social outcomes and functioning is the goal of researching SCIT. The aim of the research is to improve social cognition skills so individual's living with a SEMI may obtain greater “choice, getting and keeping of valued social roles” that provide meaningful and rewarding lived experiences. A trial of SCIT at CCU will identify if improvement in SC has been achieved with regards to skill development in social engagement and social functioning.

Contemporary Australian data suggest that pulmonary hypertension (PHT) is more common than previously reported and confers a poor prognosis, however this single-centre data needs confirmation in a large population study from many locations and diverse backgrounds. Identification of underlying cause and prognosis of PHT non-invasively using simple markers would have a major impact on the diagnosis and management of patients with PHT. PHT is often identified during echocardiography, performed for investigation of breathlessness. PHT is not a diagnosis in itself, but has a number of underlying causes that require additional investigation to delineate. Such causes include left heart diseases, various chronic respiratory illnesses, and chronic thromboembolic and pulmonary vascular diseases. Over 900,000 echocardiograms (echos) are performed in Australia each year, but to date there has been no systematic method for capturing data from these echos. The newly developed National Echo Database Australia (NEDA) is designed to obtain measurement and report data, but no images, from digital echo laboratory across Australia and transfer them to a secure database, matched against national mortality data. The NEDA database will be the largest echo database in the world. Identification of the population of patients with PHT is of great importance, both to target those who may benefit from disease-specific therapy, and to better understand all forms of PHT in Australia and New Zealand. Abnormalities identifiable using echocardiography may be very useful prognostic indicators, and may help separate various causes for PHT. This information could be used to both identify patients who may respond to treatment, and to identify them earlier, with the goal of decreasing both morbidity and mortality for this common condition.

The purpose of this study is to see if app-based mindfulness training can reduce stress and related problems for public sector employees. This three-arm parallel group RCT will assess the effects of self-guided use of the Smiling Mind Workplace App (App group) and the use of the App supported by four seminars (App+ group) on the primary outcome of perceived stress from pre- to post-intervention, when compared with a wait list control (WLC group). The relative efficacy of each active group will be assessed as a research question. Secondary outcomes include changes in mindfulness, mental health, psychosocial job quality, workplace safety and conflict incidents, productivity changes and health-related quality of life outcomes. Changes on these measures from pre- to post-intervention and then at 12-month follow-up will be investigated by group. Informant reports of observed mindfulness and citizenship behaviours will also be collected and the relationship between observer and self-reports of change will be explored. Participant reports of the perceived usefulness of program elements will be collected to inform acceptability and feasibility. User-data from the Smiling Mind servers will be used to assess adherence and to investigate effects by level(s) of engagement with the program. This study addresses the current lack of strong evidence for app-based mindfulness training for working adults. It will examine the Smiling Mind Workplace App for its efficacy for reducing stress and related mental health problems, and explore its influence on psychosocial, safety and conflict related stressors in the workplace. The study will contribute evidence regarding the importance of including teacher-led classes/seminars to support app-based learning, in terms of efficacy, and it will report economic considerations. It draws on multiple sources of data to cross-validate self-report changes, enable objective assessment of program adherence, and determine if app-based mindfulness training leads to noticeable changes in behaviour at work.

Tympanic membrane retraction can lead to increased technical difficulties for surgeons when conducting tympanoplastic procedures. Nitrous Oxide is a commonly used inhaled anaesthetic agent that has a solubility 35 times higher than Nitrogen. Its diffusion into the middle ear has been well reported and the effects on middle ear pressure and effusions have previously been investigated. Currently, at the discretion of the anesthetist and surgeon the use of Nitrous Oxide as part of anesthetic prior to surgery to the middle ear is conducted at our hospital. It has been noted that in patients with a retraction, normalization of the tympanic membrane can occur thereby allowing for ease of surgery. This study aims to assess the effect of Nitrous Oxide on retracted tympanic membranes, in a controlled manner to see if this practice should be implemented as a standard of care. It is hypothesized that the use of Nitrous Oxide at the time of induction on patients with tympanic membrane retraction will result in normalization of positioning of the membrane thereby allowing for ease of surgery. A multicenter randomized prospective control trial will be conducted at the Townsville Hospital and the Mater Health Service North Queensland. All patients undergoing middle ear surgery with a retracted tympanic membrane graded Sade 2 or higher will be assessed for suitability for participation. Patients will be randomized via random number generator into two groups of either 30% Oxygen and 70 % Nitrous Oxide vs 30% Oxygen and Air. At time of surgery following the insertion of airway device, the tympanic membrane will be visualized by the surgeon, its state recorded and tympanography will be performed. Single blinded to the Surgeon; who will leave the operating room to prepare for surgery, the maintenance gases will be commenced at 6L/min for 10 minutes. Following cessation, the surgeon will return and again visualize the tympanic membrane and repeat tympanography will be performed allowing for comparison. The operation will then commence. Following the surgery the surgeon will document his personal experience or ease of surgery using a standardized system. Postoperative nausea or vomiting will be documented as well as use of antiemetic’s. Patients will be followed up at 3 months as per our hospitals standard procedures and any complications will be noted.

The purpose of the research is to determine the feasibility of a school-based program called Making Maths a HIIT at School. This is an initiative focusing on High Intensity Interval training (HIIT) and mathematics. The program integrates mathematics and physical activity into the delivery of the school curriculum. Based on previous studies, increased participation in Physical Activity (PA) may improve cognitive functioning and academic achievement. Movement can actually aid learning and the integration of physical activity has the potential to enhance learning and student engagement in other curriculum areas.

This study will provide novel, translational data by evaluating the feasibility and efficacy of a structured, goal directed, exercise and physical activity intervention, coupled with nurse-led education, initiated within one month of implant, for patients receiving a primary prevention ICD. Across Australia, there are ~4000 new recipients of an implanted cardioverter defibrillator (ICD) annually. Recipients are commonly those with left ventricular (LV) dysfunction and/or inducible ventricular arrhythmia. Annual all-cause mortality in patients with prophylactic ICD implantation is approximately 5.0 to 8.5% . Additionally, ICD recipients report lower quality of life coupled with both anxiety and depressive symptoms, which may be exaggerated by higher prevalence of inactivity. The rationale for this study is therefore to combine nurse-led education with a physical activity intervention in new recipients of a primary prevention ICD. Both interventions are clinically effective in patients with heart failure or an ICD, yet have not been comprehensively assessed in a combined strategy.

This Phase I clinical trial will compare the bioavailability of dihydroergotamine mesylate (DHE) following a single dose administration of INP104 (DHE administered by I123 Precision Olfactory Delivery (POD TM) Device nasal spray to that of D.H.E. 45 for Injection (intravenous [IV]) and Migranal nasal spray in healthy adult subjects. It is hypothesized that INP104 will address the current variability in nasal administration and give more reproducible dose delivery compared to Migranal nasal spray. Blood concentrations of all three investigational products will be compared for 48 hours following dosing. The safety and tolerability of INP104 will be monitored throughout the study. INP104 has been developed for the treatment of acute migraine headache. The device in which the drug will be delivered has been designed to deliver the medication to the upper nasal cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the dose being swallowed. Approximately 36 participants in general good health (equal ratio of males and females desired) will be enrolled and will be allocated to receive 3 treatments in a randomised sequence. They will receive a single dose of INP104 via the POD device, a single dose of DHE via intravenous injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where no treatment will be administered for at least 7 days in between each treatment. Participants are required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be in the study for up to 43 days.

The primary objective of this study is to demonstrate that twice daily application of a ceramide dominant emollient reduces the risk of eczema and food allergy, when compared to standard skin management. Secondary objectives are to determine if twice daily application of a ceramide dominant emollient reduces the risk of infants developing allergic sensitisation (as measured by skin prick test); to determine if twice daily application of a ceramide dominant emollient improves infant skin barrier function; to determine the level of parental compliance with a program to build infant skin barrier function; to confirm that a ceramide dominant emollient does not cause adverse effects in infants; to determine the level of compliance required to demonstrate an improvement in infant skin barrier function and to determine if twice daily application of a ceramide dominant emollient influences infant skinmicrobial colonisation, or skin lipid profile. This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and food allergy in high risk infants. A total of 760 participants with a first degree family history of allergic disease (asthma, eczema, allergic rhinitis or food allergy) will be recruited (380 each group) from maternity wards of seven hospitals. Treatment will be from birth until six months, with a six week, six month and twelve month follow-up. An initial assessment will be performed at baseline which incorporates three surveys, a skin assessment, diary card (which is to be completed weekly and measures compliance), a breast milk sample, guthrie card and tape stripping. The six week assessment entails a skin assessment, survey, compliance check, breast milk sample, tape stripping and guthrie card, while the six month assessment entails a survey. Primary outcomes are assessed at the 12 month follow up where in addition to the aforementioned items, a saliva sample will also be taken and skin prick testing and food challenges will be performed when children have a positive SPT to one or more foods. The primary and secondary outcomes are assessed again at the 4-year follow-up where in addition to the aforementioned items oscillometry testing will be performed to measured lung function.

Tonsillectomy is one of the most frequently performed surgical procedures in kids, with approximately ½ million/annum in US, mainly performed as day cases. In Australia, in 2012/13, there were 38575 admissions due to tonsillectomies, representing 724 admissions per 100000 people aged 17 years and under. Sleep disordered breathing (SDB), rather than infection has become the primary reason for tonsillectomy. SDB is defined as an abnormal respiratory pattern during sleep. It presents as a spectrum from simple snoring to severe obstructive sleep apnoea (OSA). The incidence of peri-operative respiratory complications is 10 times higher for children with OSA compared to those without OSA. Perioperative respiratory adverse events necessitating a medical intervention occur in about 10% of children undergoing adenotonsillectomy, 60% of these occur in the immediate post-operative period. However, desaturations can continue for an unpredictable further period of time in a substantial number of children following tonsillectomy. Currently the gold standard test for assessing presence and severity of OSA/SDB is polysomnography. It is however, a high cost, labour intensive test and is associated with long waiting lists and therefore rarely used in these children. There has been some research on using preoperative oximetry to stratify a patient’s need for more or less observation (e.g. ambulatory surgery, ward special, ICU). This study will enrol patients scheduled for tonsillectomy and assess their baseline sleep quality via a questionnaire, overnight pulse oximetry and awake-sleep pattern using novel portable activity monitoring devices (ActiCal). These will be performed in the patient’s home prior to surgery. Then any breathing problems within 24 hours of surgery will be recorded. We will then examine if these problems can be predicted from our preoperative measures. If successful this would allow better stratification of risk of patients for tonsillectomy allowing them to get the most appropriate level of post-operative observation required for each individual child. We will then follow the patients with the same monitors for up to 14 nights after surgery to determine the extent/course of improvement provided by surgery to blood oxygen levels and the impact on sleeping pattern. This will also allow better characterisation of the course of a patient’s night time oxygen levels in the days after surgery, and allow examination of the impact of strong pain killers given around surgery on this parameter. This would help clinicians make more informed decisions in relation to length of stay after surgery. Currently there is very little data to inform these decisions or care pathways. Additionally the activity monitors will help us track the child’s return to normal physical activity which has not previously been assessed objectively. This would allow more evidenced based information to be conveyed to parents about typical recovery after tonsillectomy surgery.

This study is a randomised cross-over trial assessing the efficacy of the addition of hyaluronic acid (HA) to levobupivicane in pudendal nerve blockade as a treatment for pudendal neuralgia. Previous studies have demonstrated that application of local anaesthetic along the path of the pudendal nerve results in the onset of numbness and a reduction in symptoms. This result is however, most often limited from a few hours to a few days . Recent studies have suggested that the addition of hyaluronic acid to the local anaesthetic blockade can result in improved and prolonged analgesia. AIM; to determine whether the addition of hyaluronic acid to local anaesthetic results in improved post-blockade pain scores, change in medication use and change in pain interference in daily activities. MATERIALS AND METHODS; This is a triple-blind randomised cross-over study in which each participant will receive two pudendal nerve blocks 3 months apart one of which will contain hyaluronic acid + levobupivicaine and the other placebo + levobupivicaine. Assessment of symptoms and effect on function will be via use of The Brief pain inventory – short form. We will also assess analgesia use pre and post blockade. RESULTS; Differences in pain and function scores pre and post blockade will be assessed using the students t-test with adjustments made for multiple comparisons. We will also use descriptive statistics to review any changes in medication use. CONCLUSION; if our null hypothesis is true we would expect to see no difference between HA acid and placebo. However, if the HA is effective then we would hope to see improved pain scores, decreased pain interference with life and potentially decreased medication use.