ANZCTR search results

Intrauterine devices (IUDs) are medical products placed inside the uterus to provide patients with reliable contraception but their use is often limited by pain at the time of insertion. Virtual reality (VR) is a technology that uses a headset to create a 3-dimensional interactive environment for the user and has been shown to be helpful for improving pain in other settings. This research project aims to find whether VR can help reduce the discomfort of having an IUD inserted. The study hypothesis is that VR will help to manage the pain of having an IUD inserted.

Dental plaque has been defined as a community of microorganisms found on oral structures are embedded in a matrix of polymers of host and bacterial origin (Marsh, 2006). The nature and complexity of oral biofilms have led to the development of various intra-oral devices and models to study the oral microbiome. In vitro biofilm models with conventional culture methods have contributed to significant advances in understanding the oral microbiota, however, the in vitro model cannot mimic the exact in vivo environment which leads to incomparable biofilm to the one found in situ (Robinson et al., 1997; Yu et al., 2017). Several techniques have been identified in the literature to harvest the dental plaque by using paper points, cotton rolls, and scalers (Abdullah et al., 2019; Prada-López et al., 2016). However, these methods mentioned above are impossible to collect all bacteria from in situ and doubtlessly disrupt the three-dimensional architecture of the biofilm (Wood et al., 1999). A rapidly developing technique for studying an undisturbed biofilm is using an intra-oral dental appliance as a biofilm collection device (Abdullah et al., 2019). However, the main shortcomings of these devices are that they are removed during mealtimes with the biofilm not being exposed to the patient’s diet, as well as no exposure to gingival crevicular fluid. The aim of the project is to develop an implant-supported device that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth.

Accessing effective contraception and abortion services for women living in rural and regional areas can be challenging. The study’s primary aim is to assess the effectiveness of a nurse-led model of care (involving task-sharing, and where appropriate implant insertion by nurses and use of telehealth) in general practice for improving women’s uptake of long-acting reversible contraception and access to medical abortion in rural and regional areas. We will utilise a stepped-wedge, cluster randomised controlled trial study design to trial this complex intervention in regional and rural general practices in Australia. The delivery of the nurse-led model will be supported by a set of implementation activities consisting of (a) online education and clinical upskilling for LARC and medical abortion care, (b) educational outreach to discuss practical strategies for model implementation, and (c) participation in a digital community of practice for access to clinical experts, peer support and resources to support provision of LARC and medical abortion services. It is anticipated that broadening the scope of practice nurses to provide LARC and EMA services in general practice and supporting them in providing this service will be effective in helping overcome issues of access to LARC and medical abortion services for women living in regional and rural Australia. This has the potential to improve reproductive health outcomes for this priority population in Australia.

This randomised controlled study will examine the impact of a 3D virtual reality (VR) intervention versus a two-dimensional (2D) video on pre-operative anxiety and induction compliance. .This study will provide evidence on the ongoing clinical use of 3D VR Goggles during the preoperative period at Perth Children's Hospital (PCH), to reduce anxiety and improve coping of children undergoing surgery. Given preoperative anxiety is so common amongst children, it is vital to find suitable strategies to control and reduce this anxiety in order to improve the overall patient experience. Children exposed to negative medical experiences may have a higher incidence of negative post-operative behavioural outcomes and often display increased fear and poor coping during subsequent medical procedures. By fostering a more positive and fun environment for children through the use of 3D VR goggles, there is potential to reduce negative post-operative outcomes and help children to recall their surgical journey as a more positive, exciting and non-threatening experience. Primary hypothesis: Children allocated to the 3D VR intervention group will display a significantly smaller increase in anxiety during anaesthetic induction from baseline, compared to the 2D video group Secondary hypotheses: 1. Children allocated to the 3D VR intervention group will display better induction compliance than children in the 2D video group 2. The 3D VR intervention will be more useful than the 2D intervention in helping the child cope with the induction process

This study aims to evaluate the safety and tolerability of an experimental new drug. This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The total maximum study duration for participants is 36-39 days. Cohorts 1, 2, 3, 5 and 6: Single dose of GSBR-1290 or placebo administered on Day 1 under fasted conditions. Cohorts 4 (food effect): Single dose of GSBR-1290 or placebo administered on Day 1 under fasted conditions and another dose administered on Day 4 under fed conditions (total of 2 doses). In this study, up to 48 healthy volunteers will be enrolled across various cohorts receiving single ascending doses of the study drug. All participants will have to remain confined in the study center as required (between Days 1 to 7) depending on the cohort assigned and undergo blood tests and answer questions regarding their health

This study is investigating the safety and efficacy of cannabis in relieving distressing symptoms of advanced cancer. Who is it for? You may be eligible for this study if you are an adult with advanced histologically proven cancer (metastatic or locally advanced) and have been evaluated by a physician for suitability to join this study. Study details Participants will be randomly allocated to either take a combination of the two main components of cannabis, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in standard doses as an oral solution, or a placebo. Participants will be asked to complete simple ratings to measure symptom burden and quality of life for up to 28 days of the trial. It is hoped that data from this trial will inform the efficacy of cannabis to manage patient distress caused by cancer-related symptoms.

Constraint-induced movement therapy (CIMT) is an effective intervention for arm recovery after stroke. CIMT is recommended in national guidelines, yet only 11% of eligible stroke survivors receive CIMT. Telehealth provides opportunities to deliver CIMT to stroke survivors who live regionally or without transport. Early studies have achieved similar outcomes delivering CIMT via telehealth or online compared to face-to-face. However, implementation support was not provided in any study to embed TeleCIMT into practice. The TeleCIMT International DEvelopment group of occupational therapists, physiotherapists and researchers from Australia, United Kingdom and New Zealand have developed resources to support CIMT implementation and delivery by telehealth (TeleCIMT) in response to the COVID-19 pandemic. This prospective, single-group implementation study will evaluate the feasibility of TeleCIMT using TIDE resources, and explore therapists’ experiences and use of online implementation resources to support TeleCIMT delivery.

This study will be investigating the effectiveness of electroacupuncture in treating chemotherapy-induced peripheral neuropathy (CIPN) during paclitaxel chemotherapy for breast cancer patients. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with stage I-III breast cancer and have been scheduled to receive weekly adjuvant or neoadjuvant paclitaxel treatments Study details Participants will be randomly allocated to receive 10 weekly sessions of either electroacupuncture or sham electroacupuncture. Feasibility and acceptability of the intervention, as well as any changes in CIPN symptoms, will be assessed over the course of the study. It is hoped that information from this study will inform researchers of any potential benefits that electroacupuncture has for treatment of CIPN.

The purpose of this study is to assess the accuracy and utility of MRI imaging in patients who are in active surveillance. Who is it for? You may be eligible for this study if you are an adult male, who has been diagnosed with low risk prostate cancer and your urologist has put you in active surveillance. All participants will be asked to undertake an MRI scan, have their blood test for PSA test result and have the urologist conduct a direct rectal exam within (6 months prior to your biopsy, 1 yr, 2 yrs and 3yrs). Follow-up will be as per standard of care with the urologist

Exercise has the potential to enhance the quality of life for people receiving peritoneal dialysis, however, there is concern regarding risk. It is vital to understand risks associated with exercise and physical activity for people receiving peritoneal dialysis. Thus, the aim of this survey is to address this knowledge gap by exploring the characteristics and frequency of adverse health events reported by people receiving peritoneal dialysis related to exercise or physical activity. Participants will anonymously complete a survey that takes them through a list of adverse events asking if they have experienced the respective event either during, or soon after participation in physical activity or exercise. Identification of these events will provide increased understanding of the safety of exercise or physical activity for this population. This will enhance the ability of patients and clinicians to make evidence informed decisions regarding possible risks while awaiting the necessary rigorous intervention and adverse event data.