ANZCTR search results

During general anaesthesia muscle relaxant drugs are administered to make airway management and surgery easier. Muscle relaxants are usually reversed with neostigmine at the end of the operation. A newer drug, sugammadex, reverses muscle relaxants more rapidly than neostigmine, but is not clear whether sugammadex results in fewer postoperative complications than neostigmine. We are conducting a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine.

Chronic pain is one of the most common chronic conditions in Australia and the prevalence is on the rise. It is estimated that by 2050, the prevalence of chronic pain will rise to 5.23 million Australians. People with chronic pain suffer not only physically, but also financially and emotionally. One of the eight goals identified by Painaustralia in the National Strategic Action Plan for Pain Management (2021) is for “People living with pain have timely access to consumer-centered best practice pain management including self-management, early intervention strategies and interdisciplinary care and support”. Chronic pain can have a significant impact on mental health and they commonly occur together. Depression and anxiety are the most common comorbidities associated with chronic pain in Australia at 44.6%, followed by osteoarthritis and degenerative arthritis (29.3%) and hypertension(25.1%). Nearly half of the patients with chronic pain presenting for treatment suffer from major depression. Major depression in people with chronic pain often leads to reduced functioning, poorer treatment response, and increased healthcare costs. Breathing intervention is an effective self-management for a range of medical and mental health conditions. To date, there has not been a reported randomized control trial examining the effectiveness of a breathing intervention for adults with a range of chronic pain types. This research aims to examine the efficacy of telehealth-based group breathing intervention on patient-reported outcomes in patients with chronic pain as compared to usual care. The research question for this trial is “In people living with chronic pain, what is the effect of a telehealth-based group intervention on mood, pain intensity and interference, catastrophising, and self-efficacy compared with no breathing intervention within a 12-month period?”. The hypothesis of this randomised control trial is “telehealth-based group breathing intervention is beneficial for improving patient-reported outcomes in adults living with chronic pain”. Once consented to participate this research, participants will be randomized to either treatment (telehealth breathing intervention group) or usual care (control group). Patient reported outcomes will be collected at baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment, and 6 months post-initiation of treatment.

The proposed study will deliver an existing validated and empirically supported Cognitive Behaviour Therapy (CBT) program, Exploring Feelings - Anxiety, for anxious young autistic children. The program will be slightly extended based on the results for an earlier study, by way of the inclusion of two additional sessions specifically focused on social skills. A within-subjects design with repeated measures will be used to evaluate changes in levels of anxiety across the delivery of the program. Delivery of pre- and post-intervention assessments along with session-by-session measures will allow the researchers to explore (a) changes in anxiety levels from before to after intervention delivery, and (b) if any changes that do occur are more likely at certain timepoints of the intervention, pointing towards particular components of the intervention as being more helpful than others.

The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery. It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.

It is anticipated that intra-uterine instillation using autologous platelet-rich plasma (A-PRP) injected into the uterus will improve successful pregnancy outcomes in current IVF cycles and frozen embryo transfer cycles for women either with RIF, an endometrium of <7mm, or an Asherman's Syndrome diagnosis. In the non-randomised prospective trial, around 10mLs of your own blood (autologous) will be collected to produce around 1mL of A-PRP. The A-PRP will be injected into the uterus transvaginally via an embryo transfer catheter either 48 hours prior to trigger for thin endometrium cases or 48 hours prior to ET for RIF cases.

By 2030, road crashes are predicted to be the fifth leading cause of death globally. Although Australia has made great strides in road injury prevention and safety, road fatality rates have plateaued over the last decade. Of concern is the fact that young drivers are overrepresented in road injury and fatality statistics in Australia - whilst young drivers comprise only 14% of all licence holders, they are involved in about one-fourth of all serious crashes (Australian Transport Council 2011). For young people aged 18-25, driving is a high-risk activity, with the risk of a crash greatest in the first six months of licensure (VicRoads 2005). In-vehicle telematics presents a promising technological means of reducing road trauma. Telematics technology generates real-time motor vehicle data, such as acceleration and braking information, providing drivers with direct feedback on driving performance. Moreover, linking safety-specific feedback with financial incentives may achieve safer driving behaviours. This study aims to assess whether personalised safety feedback linked to financial incentives will improve driving behaviour and reduce road crashes among novice drivers. This study will be the largest trial of personalised transport safety feedback delivered using telematics technology in Australia. Recent aforementioned research highlights that personalised driving feedback and financial incentives shape safer driving behaviours (Mortimer et al. 2006; Stevenson et al. 2018), and this study will extend this important finding by assessing the likely impact that personalised safety feedback and incentives have on reducing the likelihood of road crashes. This study will be a crucial step in advancing scientific knowledge around road safety and enabling large-scale implementation of interventions to reduce road trauma. A unique element of this trial is that it delivers across the entire state(s). Most technology trials have relied on participants and researchers in close proximity to ensure appropriate installation of the technology in-vehicle, and hence have been wholly delivered in urban environments. This trial, on the other hand, will overcome the underrepresentation of regional and rural young drivers in such studies. This is a significant strength as about two-thirds of serious injuries and fatal crashes occur in regional and rural areas. In the past decade, hospitalisations from road crashes in Australia have not declined. As such, the market penetration of technologies like telematics highlights the opportunity to reduce the burden of road traffic injury. Furthermore, this research will provide decision-makers with data in order to guide policymaking. Our research will generate new knowledge that can be directly translated into transport safety policies associated with all newly licensed drivers.

Our team created a new online interactive tool, the Sydney Health Literacy Lab (SHeLL) Health Literacy Editor, to help health services staff write health information that is easy to understand. The Editor gives users real-time feedback to help them write more simply and apply health literacy principles. The aim of this study is to see how well the Health Literacy Editor works. To do this, we will ask participants to simplify health texts using either the Health Literacy Editor, or their usual processes. We will then compare findings across the two groups. We hypothesise that when participants use the Health Literacy Editor to help them revise a text, the health information is easier to understand (e.g. lower grade reading score).

IBD populations experience 2-3 times higher rates of mental health comorbidities in comparison to healthy individuals. Researchers have investigated mental health as contributing to the pathogenies of IBD, finding a significant two-way gut-brain relationship. Mindfulness-based interventions (MBI’s) have been examined as a psychotherapy for IBD. MBI’s aim to foster non-judgmental awareness of emotions, thoughts, and behavior, to support self-regulation. A recent systematic review found MBI’s to be effective in improving IBD biopsychosocial outcomes, including CRP, stress and HRQoL, concluding that MBI’s may be a useful adjuvant therapy in IBD care, with further trials warranted. The review highlighted several limitations providing considerations for the current trial including; trials utilizing unselected participants without psychological distress, no trial utilizing an online intervention, and lack of interventions adapted to IBD. This study aims to evaluate the feasibility and preliminary efficacy of a 6-week online MIND4IBD program, adapted for individuals with IBD, experiencing psychological distress.

Up to 30% of patients with epilepsy are resistant to current anti-seizure medications, i.e. drug-resistant epilepsy (DRE). Resective surgery of the epileptogenic regions is the most effective option to treat patients with DRE. Unfortunately, up to 60% of DRE patients are not suitable for resective surgery. Neuromodulation approaches are increasingly being utilized in patients with DRE. The current approved techniques use invasive neuromodulation, which require complex neurosurgery and could cause side effects, such as infection, bleeding, and non-target brain tissue damage. Focused ultrasound (FUS) is a novel, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with epilepsy. NaviFUS System (a neuro-navigation guided focused ultrasound system) is one of the FUS technologies that uses low-intensity focused ultrasound (LIFU) phased array system to deliver transcranial burst-mode ultrasound energy to induce neuromodulation effect and block signals in a specific area of the brain that cause symptoms of epilepsy such as seizures. The pilot clinical study has demonstrated that NaviFUS System safely delivered LIFU to the seizure onset zone and modulated the neuronal activity. Participants in this study will receive FUS treatment with the NaviFUS System, guided by the neuronavigation system. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi. Briefly, the study consists of a 60-day screening period for baseline observation prior to treatment, a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System, and a safety follow-up period of 81 days.

To evaluate the effects of oral care agents on white spots, healthy human participants will wear appliances with tooth slabs containing artificially-created early decay (white spots) attached. During each 14-day treatment period, a slurry of each dentifrice formulation will be prepared by diluting 1 g of the product in 4 mL of distilled de-ionized water in a 15mL tube. Four times a day at 9:30 am, 11:00 am, 1:30 pm and 3:30 pm, participants will rinse with 5 mL of a 10% sucrose solution (supplied) for 60 seconds. They will expectorate the sucrose rinse after 60 seconds. Forty minutes after each sucrose rinse, participants will shake their slurry solution and immediately rinse with all 5 mL of their allocated slurry for 60 seconds (i.e. four times a day at 10:10 am, 11:40 am, 2:10 pm and 4:10 pm). They will then expectorate the slurry. Participants will (gently) remove their appliances only when they brush their teeth and clean their appliances in the morning and at night without touching the wells holding the enamel/dentine pieces. There will be at least a week’s rest between each treatment period with a different slurry allocated for each treatment period. The order of slurries for each participant will be unknown to the participants or researchers. At the end of each treatment period, the slabs from the appliance will be returned and x-rayed outside the mouth to measure repair of decay. Closure of dentine tubules will be analyzed with microscopy. This project will provide valuable information for development of novel toothpastes.