ANZCTR search results

This randomised study will evaluate the efficacy of intravenous lignocaine as an alternative analgesic in patients undergoing percutaneous coronary intervention to fentanyl which is standard of care. The rationale behind this study relates to multiple biochemical studies demonstrating delayed absorption of antiplatelet agents when opioid analgesia is administered. Furthermore, these studies demonstrate that by delaying gastric absorption, the antiplatelet effects of ticagrelor based on platelet function are also delayed. Retrospective analysis of large clinical studies suggest poorer clinical outcomes in patients treated wtih opioid analgesia. Patients admitted and consented for coronary angiography will be recruited from The Alfred Hospital, Victoria. Patients presenting with STEMI, cardiogenic shock, out of hospital cardiac arrest, previous opioid or P2Y12 administration, coagulopathy or allergy to opioids or lignocaine will be excluded. Patients undergoing percutaneous coronary intervention will be randomised to receive either lignocaine or fentanyl as follows: For patients allocated to lignocaine: - Lignocaine 1mg/kg (maximum dose 100mg) will be given as a bolus at the start of the case - During the case, if analgesia is required a further bolus of 0.5mg/kg will be given. - If satisfactory analgesia is not achieved then patient will crossover to fentanyl arm - Total lignocaine dose will be recorded For patients allocated to fentanyl: - If under 70 years of age 0.75mcg/kg of Fentanyl IV will be given at the start of the case. If >70 years of age 0.5mcg/kg will be given at the start of the case. - Further IV fentanyl boluses can be given at the discretion of the interventional cardiologist if further analgesia is required during the case - Fentanyl IV 0.5mcg/kg mcg will be given at the end of the case at the time of administration of ticagrelor. Study endpoints will evaluate the efficacy of intravenous lignocaine in terms of analgesic efficacy and assess the interaction in terms of platelet function studies and pharmacokinetic analysis. This will determine if lignocaine is a safe, effective alternative analgesic which does not interact with antiplatelet agents.

The purpose of the study is to compare a new way of undertaking informed medical consent, that being with the aid of a video, to the regular way a doctor would tell you about the procedure (which is usually a conversation between the doctor and yourself). Who is it for? You may be eligible for this study if you are aged 18 or over and are attending Royal North Shore Hospital or The Skin Hospital (Darlinghurst) for Mohs micrographic surgery. Study details Participants will be randomised by chance into two groups. One group will first watch a 6 minute video about the procedure before talking with their doctor to address any questions. The other group will only talk with their doctor (usual practice). As part of this study, all participants will complete a number of questionnaires before and after the consent process. It is hoped this research will show improved patient comprehension of the risks and benefits of the procedure, enhance patient satisfaction with the consent process, lower anxiety levels and save time.

This study is to investigate the effectiveness of Imagery Rescripting (IR) in treatment eating disorders. It is common for people with eating disorders to report that memories of early negative experiences related to their body or eating (e.g., being teased about weight), or even unrelated to their body or eating (e.g., being rejected by a friend), are still relevant to how they feel emotionally about their body and eating today. With the use of IR, we go back in our imagination to experience the past event from a new perspective. We hypothesized that eating disorders treatment is more effective in decreasing disordered eating behaviours and improving body image among people with an eating disorder than with IR is used as a treatment adjunct.

The aim of this project is to examine the role of a ‘global’ coagulation assay called Rotational Thromboelastometry (ROTEM) in the guidance of prophylactic blood product in patients with liver cirrhosis undergoing invasive procedures. Currently available laboratory tests (such as platelet count, International Normalised Ratio (INR) and activated partial thromboplastin time (aPTT)) are suboptimal for the assessment of bleeding risk in patients with chronic liver disease. These tests may overestimate the risk of bleeding, and their use may result in unnecessary transfusion of blood and coagulation products, exposing the patients to risk of serious adverse events and potentially overuse of scarce blood products. During the past few years, ‘global’ coagulation tests such as ROTEM have been developed to provide an overall measurement of the clotting system. These point of care tests provide quick results and have been used to assess coagulation and better guide blood product transfusion in a number of surgical and trauma multi-transfusion settings. However, the value of these global tests in predicting bleeding outcomes and guiding blood component transfusion in liver disease has not been well studied. We plan a multi-centre randomised-controlled trial (RCT) examining ROTEM-based decisions to guide FFP and platelet use in patients with cirrhosis undergoing invasive procedures. We hypothesise that using ROTEM to guide blood product delivery in this setting, will lead to reduced usage of blood products whilst maintaining optimal clinical outcomes.

This is a pragmatic trial designed to test the effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain. It is a pragmatic design as it is testing two active interventions that people commonly seek for management of musculoskeletal pain, and the interventions are applied with real-world authenticity. The study aims to see if these interventions improve the pain and health status of participants, and whether the osteopathic healthcare intervention is any more effective than the standardised exercise and activity care plan. The core elements of the osteopathic healthcare intervention has been established through research, and includes assessment of musculoskeletal function, manual therapy, education, therapeutic exercise and health promotion advice. The exercise and activity care plan intervention is based on evidence based guidelines for chronic low back pain. After screening for the inclusion and exclusion criteria, participants will complete the first outcome measurements, and then be randomised into groups and receive four weekly consultations. The second outcome measurement will be completed immediately after the final consultation, the third 2 weeks after the interventions and a fourth 6 weeks after the end of interventions in order to test short and medium terms outcomes. Statistical approach is by Intention To Treat, and analysis will be undertaken using a multivariate approach and calculating effect sizes.

The primary aim of this study is to determine whether the addition of IRT to CBT-I improves sleep disturbances in ex-service personnel with PTSD, insomnia, and nightmares compared to CBT-I alone. This study also aims to explore if risk of obstructive sleep apnoea (OSA) negatively moderates treatment outcomes in ex-service personnel receiving either CBT-I or CBT-I+IRT. Participants will be a minimum of 60 ex-serving personnel with PTSD, insomnia, and nightmares. Eligible participants will be randomised to either CBT-I or CBT-I+IRT treatment groups. Participants will attend 8 x weekly 60 minute CBT-I group sessions or 8 x weekly 120 minute CBT-I+IRT group sessions. Participants will complete a series of outcome measures at three time points (baseline, post-intervention, and at three months post-intervention). It is expected that the addition of IRT to CBT-I treatment will result in greater reduction in sleep disturbances than treatment with CBT-I alone.

Research Question: Does Visualisation Affect Pain and Function in Achilles tendonopathy (AT)? Pain is clearly a complex process and involves integration of multiple streams of sensory information. An area of recent research interest has been the integration of what a person sees to augment or moderate the pain experience. Visually-induced analgesia is a term used to describe the reduction of pain intensity by directly viewing one’s own body-part when painful stimulation is applied. In chronic low back pain for example, patients’ visualisation of their lumbar spine reduced pain with movement. We hope to explore this phenomenon to see if, and to what extent, it exists in AT, and to simultaneously investigate the effect of vision on tendon function – something which no study of visually induced analgesia has done before. The aim of this study is therefore to examine the effect of visualisation on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT while they view a video image of their leg and compare these results with a no vision condition. This study will help inform whether non-nociceptive information sources are important in influencing pain in a clinical condition while performing a functionally relevant task, reveal if any changes in pain are associated with functional performance changes and may inform management strategies for the management of AT.

The purpose of this study is to assess whether the drug PAX-1 can delay cancer progression in patients with recurrence glioblastoma. Who is it for? You may be eligible for this study if you are aged 18 to 70, diagnosed with recurrent glioblastoma. Study details Participants who are resistant to SOC therapy will receive PAX-1 monotherapy alone until disease progression/recurrence or patient withdrawal (due to intolerance or withdrawal of consent).Patients will receive a maximum daily daily 15 mg oral dose of PAX-1 Every 8 weeks the patient will have a scan of their tumour to determine whether the therapy is working. It is hoped that information gained in this study will aid in the understanding of treatment of glioblastoma and help in the development of new approaches to its treatment and the care of future patients who share your condition.

A compassion-based digital health program (called CompassionateUs) to increase psychological wellbeing, for adults in the general community, will be evaluated. CompassionateUs is one of the digital health programs offered through the My Digital Health platform. People who consent to take part in the study will be randomly allocation to one of three conditions upon completion of the pre-program survey. The three conditions vary based on when program modules are released (i.e., all modules are open from first login; modules are released on a time schedule; modules released sequentially, following completion of the current module). The CompassionateUs program consists of 10 brief modules (i.e., 5 compassion-knowledge building and 5 compassion-skill building), delivered over 8 weeks. Each module will take 10-20 minutes to read and to consolidate learning, participants will be asked to complete various practise activities (10 minutes per day on average). Participants will also receive automated emails (e.g., when a module is released, once they have completed a module, when scheduled program assessments are due). It is expected that people who undertake the CompassionateUs program will show improvements in their psychological wellbeing (e.g., self-compassion levels) at post-intervention and follow-up assessment time points.

A multi-centre randomised design will be utilised to compare control centre normal practice conditions with intervention centres receiving physical literacy educator professional development and curriculum support. Approximately 60 educators and 300 children (age 4 to 5 years) will be recruited from 16 Early Learning Centres in Queensland and NSW. Centres will be randomly allocated (stratified cluster randomization) to either intervention, or control over a 24-week period. The reach, effectiveness, adoption, implementation, of the intervention will be examined. Change in aspects of children’s physical literacy will also be assessed. Assessments will be conducted at baseline and 6 months (end of intervention),It is hypothesised that educators receiving the intervention will improve the provision of physical literacy activities to children and that children receiving the intervention will have greater improvements in physical literacy.