ANZCTR search results

This study is a multi-site parallel group cluster randomized trial delivering pain education and biopsychosocial care to students attending secondary schools. This school-based intervention aims to provide the opportunity for all adolescents to access accurate and evidence-based information about pain and pain management. This study is a three-arm parallel group cluster randomized trial, with economic evaluation. Participating schools will be randomly allocated to 1) pain education module and parent resources, 2) pain education module and parent resources, plus biopsychosocial care for students reporting problems with pain, or 3) no intervention.

Tonsillectomy is one of the most common childhood surgical procedures, however the postoperative recovery is often long and challenging for children and their families. This study aims to investigate if seven days of oral melatonin is able to improve sleep and pain management in children post-tonsillectomy, without increasing the risk of postoperative complications compared to placebo. We hypothesise that: (1) Melatonin will improve sleep following tonsillectomy; (2) melatonin will decrease post-operative pain and reduce breakthrough opioid requirement; and (3) melatonin will not increase the risk of post-operative complications.

There is an increasing focus on, and acknowledgement of, the role of behaviour change science, in modifying health and other behaviours. The current project involves developing a behaviour change readiness index for predicting health behaviour change in the domain of dietary interventions. The study focuses on understanding behavioural outcomes rather than improving health behaviours. Therefore, a simple health behaviour (improving water intake) will be used as a behaviour change target. The aim of this study is to refine and validate the CSIRO behaviour change readiness index by assessing its utility to predict successful short-term behaviour change in the dietary domain (i.e., water drinking) but also to better understand the associations and strengths of relevant psychological factors to refine this tool into a succinct survey.

The primary objective of the proposed study is to evaluate the safety and tolerability of the Coolio System when administered as a genicular nerve block for pain management in subjects with osteoarthritis of the knee. The secondary objective of the study is to observe analgesic performance of the device. The Coolio System intends to utilize cold temperatures to temporarily inhibit nerve signaling through the injection of Neural Ice into the extra-neural space of target sensory nerves. Brixton Biosciences hypothesizes that the injection of Neural Ice around three genicular nerves in the knee can reduce knee pain associated with osteoarthritis. The anesthesiologist-investigator will inject Neural Ice around these three nerves and evaluate pain scores and other assessments throughout a 6-month follow-up period.

We aim to improve vegetable intake of 3-5 year old children in Early Child Education and Care (ECEC) services and at home through targeted strategies. These include a children's daily mid-morning vegetable break and experiential learning activities while in ECEC, parental resources and ECEC educator professional development support to support children's behavioural intentions and increase opportunities to eat vegetables. Efficacy will be primarily measured by change in skin carotenoid levels. Secondary outcomes include changes in child preferences for vegetables and vegetable provision by parents in lunchboxes. A process evaluation to assess the implementation fidelity of the program strategies will also be undertaken.

This trial will assess whether a single dose of azithromycin (or placebo) given shortly before birth will reduce maternal and infant infections requiring antibiotic intervention in the 6 weeks following the birth, Pregnant women will be randomised close to time of delivery, and followed up for 6 weeks. Nasopharyngeal and vaginal swabs will be collected to monitor the impact of azithromycin on colonisation and resistance. Primary outcome assessment of new infections will be done by review of clinical presentations at primary health care and hospital.

Previous research has identified the need for urgent interventions to improve quality of care for people accessing residential respite care (i.e. ‘recipients’) and their carers (Sarris et al., 2020; Temple et al. 2020; Willoughby et al., 2018 ) . The 3C Program aims to respond to these concerns by addressing the following three key areas to improve the quality of residential respite care: Comprehensive assessment that identifies health issues and care needs Care planning that is tailor-made for the needs of the individual (and their carer), (Clinical) Communication during handover/admission to respite care that will be aided by the novel use of user-friendly video technology (These are the "3 Cs"). The objectives of this research project are to develop, implement and evaluate the 3C Program for respite care recipients and their carers who are planning to or accessing residential respite care. The project team anticipates that this form of improved respite planning will lead to better outcomes for respite recipients and their carers, such as: improved quality of life and wellbeing, improved experiences with respite care and the transitions between home/respite, consumers identifying a greater likelihood of using respite care again in the future and reductions in unnecessary hospitalisations during respite care.

This is a randomised, double-blind, placebo-controlled, First-in-Human Study to assess the safety ofXG2002 and how this drug acts in the body in healthy volunteers. XG2002 may be indicated for use in patients with acute and chronic pain, but a trial of the drug in healthy volunteers is needed before trials in patients suffering from acute and chronic pain can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of XG2002 or placebo. All participants will have their vital signs checked (heart rate, blood pressure with Core Body Temperature (CBT) being measured by an ingested real-time monitoring device), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of XG2002 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of XG2002 that can be administered safely without causing severe reactions. Once the dose of XG2002 has been determined in healthy volunteers, a trial investigating the efficacy of XG2002 as a treatment for patients with acute and chronic pain may proceed.

Polyphenol-rich sugarcane extract (PRSE) is derived from sugarcane molasses. Polyphenols are naturally occurring substances in plants, known to reduce blood glucose levels. The aim of this study is to investigate the ability of PRSE to reduce blood glucose levels after eating a sandwich. We will investigate two doses of PRSE to find out the best concentration to reduce blood glucose levels of healthy people

The study is a randomised control trial (RCT) testing a self-directed online childbirth education course aimed at improving a mother’s childbirth self-efficacy and reducing the onset and/or severity of birth related PTSD symptoms, and in turn improving mother-infant bonding. The experiment was conducted as a primary prevention study by recruiting women during pregnancy. It was hypothesised that the intervention group would report greater prenatal childbirth self-efficacy, less postnatal birth related PTSD symptoms and greater mother-infant bonding than in control groups.