ANZCTR search results

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.

The Point of Care Peritoneal Dialysis System Early Evaluation Study (POC-PDEE) will utilise different methodologies to establish the safety, efficacy and usability of the Ellen Medical - Point of Care (EM-POC) peritoneal dialysis system with Australian dialysis patients as a key step in the system evaluation. This study comprises three inter-linked components: (1) a series of human factors usability assessments, (2) a shadow study testing the reliability of the chemical composition and sterility of PD fluid produced by the EM-POC system when used by dialysis patients or their carers independently at the point-of-care and (3) patient perspectives regarding the EM-POC system, it’s usability and the training provided prior to using the EM-POC system will be sought through semi-structured interviews.

Social anxiety is a prevalent mental health condition, with 4.2% of the population meeting the criteria for social anxiety disorder within a 12-month period (McEvoy et al., 2011). Current treatments for social anxiety tend to focus solely on individual psychological factors (e.g., a person’s negative thoughts) while ignoring the influence of social factors. Groups 4 Health (G4H) has strong potential to address social anxiety symptoms because it focuses on these social factors and how they influence health. G4H is a manualised group therapy program that seeks to increase social connectedness by building group-based connections over five sessions. Its effectiveness for depression and loneliness has already been demonstrated in three trials (i.e., Cruwys et al., 2021; Haslam et al., 2016; 2019), however, it has not yet been tested in people with elevated social anxiety symptoms. Our study is a pilot test of G4H for people with social anxiety. We aim to recruit 80 people with elevated social anxiety symptoms. The primary outcomes we will use to assess whether the intervention is effective are social anxiety and loneliness. Our secondary outcomes include participants’ social connection to their therapy group, depression, multiple group memberships, social isolation, self-focused attention (which has been linked to social anxiety), and wellbeing. We are also interested in what therapist behaviours help foster a sense of connectedness in the therapy group and thus other secondary outcomes include therapists’ identity leadership (a leadership style that aims to build group connectedness) and social support. We hypothesise there will be reductions in social anxiety, loneliness, depression, social isolation, and self-focused attention across the course of therapy, and increases in social connectedness to the therapy group, multiple group memberships, and wellbeing. We also expect that these outcomes will be better when therapists engage in more identity leadership and provide more social support.

Glaucoma and diabetic retinopathy are leading causes of irreversible blindness in Australia which pose considerable public health concerns. Early detection and appropriate management is required to prevent vision loss and blindness. A gap between best practice recommendations and actual care provided for people with glaucoma and diabetic retinopathy exists. This project aims to test the feasibility and potential effectiveness of a quality improvement program for optometrists to improve the quality of care provided by optometrists to people with diabetes and with or at risk of glaucoma. The quality improvement program for optometrists consists of self-assessment with benchmarking, peer support, educational activities and resources.