ANZCTR search results

This study tested whether listening to a guided meditation audio track after hip or knee replacement surgery reduces pain and anxiety during early recovery. Adults undergoing hip or knee replacement were randomly allocated to one of three groups: a 40-minute guided meditation audio track incorporating neural entrainment technology, an identical-sounding placebo audio track without the entrainment technology, or usual care. Participants in the audio groups listened to their track daily for 14 days, beginning the day after surgery where practicable. Pain and anxiety were measured before treatment and after the 14-day intervention period. We hypothesised that participants in the guided meditation group would report greater reductions in pain severity, pain interference, and anxiety than participants receiving the placebo track or usual care.

Muscle wasting is a major driver of ICU acquired weakness, impacting recovery. Critically ill patients have impaired muscle protein synthesis. Therefore, delivering additional protein does not result in increased muscle mass. This study aims to identify the point at which ICU patients regain the ability to utilise dietary protein for muscle protein synthesis, by measuring changes in whole-body protein synthesis rates using amino acid tracer methodology. It is hypothesised that post-prandial whole-body protein synthesis rates will increase over time, indicating patients are less anabolically resistant post-ICU and therefore have a greater capacity to use dietary protein to stimulate protein synthesis.

Aim: We aim to explore the incorporation of the Biomotum Spark ankle exoskeleton into blocks of goal-directed, participation focused therapy e.g. bike-riding, endurance training, engagement with peers at school lunchtime, and gather the insights and perspectives of the delivery mode from all key stakeholders (people with cerebral palsy, their families, their clinicians, and organisation administrators). Research Question 1: What are the benefits and challenges of incorporating robotic mobility technology into a block of goal-directed therapy? Research Question 2: What are the benefits and challenges of implementation of robotic mobility technology within a large disability organisation? Research Question 3: What is the user experience, for all stakeholders, of implementation of robotic mobility technology? ?

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat severe aortic stenosis. A common problem after TAVI is disruption of the heart’s electrical system, which can cause the heart rate to slow and may require a permanent pacemaker. Irregular heart rhythms, such as atrial fibrillation can also occur and may require blood-thinning medication to reduce the long-term risk of stroke. In this study, all patients undergoing TAVI at two centres in Sydney, Australia will receive extended heart rhythm monitoring for 28 days before their procedure. After TAVI, they will be randomly assigned to either standard care, with no routine rhythm monitoring after discharge, or a further 28 days of extended heart rhythm monitoring. Patients will be followed up at 1 month and 1 year after TAVI. The study aims to improve our understanding of baseline conduction disease in severe aortic stenosis and the utility of extended ambulatory monitoring for earlier detection of important rhythm disturbances after TAVI. This can help refine periprocedural risk stratification, inform targeted surveillance and support early discharge pathways.

This study is Part 2 of this Phase 1 study. Part 1 is ACTRN12626000320358. Part 2 evaluates the effect of famotidine, on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of famotidine will not significantly change the systemic exposure of a single 75 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without famotidine. The timing of famotidine dosing relative to ATH434 is adaptive and may be altered based on emerging data from Part 1. The proposed famotidine dose timing is either 10 hours before ATH434 dosing or 2 hours after.

This study will evaluate whether providing several rapid sexually transmitted infection (STI) tests together during a single clinic visit can improve timely diagnosis and treatment for people who may experience barriers to accessing conventional sexual health services. Participants attending the Access Health clinic will be offered point-of-care testing for HIV, syphilis, chlamydia and gonorrhoea, with Mycoplasma genitalium testing offered where clinically indicated, alongside routine laboratory testing. The study will assess whether this approach is feasible and acceptable, how well the point-of-care results agree with routine laboratory results, and whether people with a positive chlamydia, gonorrhoea or Mycoplasma genitalium result can start appropriate treatment during the same visit. It will also examine the experiences of participants and service providers, as well as the costs and practical requirements of delivering the service. We expect that integrating multiple point-of-care tests into the clinic will support faster result delivery and same-visit treatment where appropriate, while providing evidence about whether this model could be sustained and expanded in similar services.

This project aims to co-design, deliver and evaluate to pilot stage, a health service integration program, The Youth Service Integration Resource Kit to improve integrated mental health care for young people. This pilot feasibility RCT study is a second phase installment. This pilot feasibility RCT will evaluate the refined Resource Kit to assess the feasibility and implementation with headspace and LHD centers and other community-based mental health services and if acceptability will be sufficient to recommend if a definitive national trial is warranted. We will recruit participants from ten sites from headspace and corresponding LHD’s. From these sites we will recruit and consent staff, clinical managers and clinicians. Phase 2 will also include recruitment and focus groups with headspace clients.

In this project we will implement a CYP2C19 genetic testing service in patients who are undergoing percutaneous coronary intervention, to guide antiplatelet therapy and reduce the risk of recurrent ischaemic events. The aim of the project is primarily to investigate adoption of the service in routine practice. Secondary aims are to determine clinical efficacy and cost-effectiveness.

Central venous catheters are commonly inserted in critically ill patients to give medications and other treatments. A chest X-ray is routinely used to confirm that the catheter is correctly positioned and to check for complications, but waiting for an X-ray may delay use of the catheter. This study will investigate whether bedside point-of-care ultrasound can accurately and more rapidly confirm central venous catheter placement in adult intensive care patients compared with standard chest X-ray confirmation. Participants will be randomly allocated to either standard chest X-ray confirmation alone or bedside ultrasound assessment in addition to standard chest X-ray confirmation. The study will assess the accuracy and speed of ultrasound confirmation, its ability to identify complications such as pneumothorax, agreement between ultrasound operators, protocol adherence, and potential effects on healthcare costs and clinical workflow.

Epidural analgesia is a common choice for women in labour. There is no evidence about how to best manage the positioning of a woman once an epidural has been placed. When no epidural is used, evidence supports upright positioning in labour, but this is not the case for women with an epidural where the opposite is true. We aim to fill an important gap in the literature about the management of a woman’s position when using an epidural to maximise safe and spontaneous vaginal birth. We are proposing a randomised controlled trial comparing usual care with structured position changes from side to side every hour and assessing the effect on spontaneous vaginal birth, as well as other important maternal and neonatal outcomes, and maternal experiences in labour.