ANZCTR search results

Motherhood can give rise to significant physical and psychological difficulties. It is worthwhile to explore interventions that may improve mothers’ psychological functioning and support the development of the mother-infant bond. This study will test a novel flexible perspective taking intervention, comprising of: (1) ACT metaphors for enhancing a transcendent sense of self and applying them to perinatal context, (2) a guided experiential exercise on flexible perspective taking for pregnant and new mothers. Previous research has supported the effectiveness of brief online interventions for mothers of infants in Australia. The current study takes a similar approach by assessing the efficacy of a flexible perspective taking intervention.

Vulvar lichen planus (VLP) is a chronic inflammatory dermatosis characterized by erythema, erosions and hyperkeratosis on the vulva with possible vaginal involvement. The condition is particularly difficult to treat and runs a chronic and progressive course, requiring long-term management and follow-up. The first-line treatment for VLP is potent topical corticosteroids. However, approximately 20-40% of patients require second-line treatment with systemic immunosuppression to control their disease. Some of the systemic medications that have been used to treat VLP include prednisolone, methotrexate, mycophenolate mofetil, azathioprine, hydroxychloroquine and cyclosporine, with varying results. The best documented agent appears to be methotrexate, with authors reporting moderate efficacy and safety profile. However, these studies were either retrospective or small case series. Overall, there is a lack of high-quality evidence, such as randomized controlled trials (RCTs), to compare and guide second-line systemic treatments in VLP. The pathogenesis of VLP is not completely understood, but there is evidence of involvement of tyrosine kinase 2 (TYK2) mediated pathway. One drug known to modulate the TYK-2 pathway is Deucravacitinib (BMS-986165), a novel, oral, selective TYK-2 inhibitor. It is being studied in patients with psoriasis, psoriatic arthritis, and systemic lupus erythematosus with promising results. Given the lack of high-quality evidence to guide the use of second-line systemic treatments in VLP, the evidence of involvement of TYK2-mediated pathway, and that the best documented systemic agent in VLP to date is methotrexate, the aim of this study is to conduct a double-blinded RCT comparing the efficacy and safety of Deucravacitinib to that of Methotrexate, in patients with VLP who have failed first-line treatment with potent topical corticosteroids. Hypothesis: Deucravacitinib will be superior to methotrexate in treating VLP patients who have failed topical therapy with potent corticosteroids.

Sevoflurane is used to induce and maintain anaesthesia. Use of this drug is associated with an environmental and financial impact. Nitrous oxide is also used to maintain anaesthesia. After use in theatre, these gases are expelled to the environment outside the hospital and contribute to global warming. We have a responsibility to reduce waste and care for the enviroment. Use per case and waste will be reviewed. After a period of intervention including raising awareness and education, use per case and waste will be reevaluated to determine if the use, average flow rate and the ratio between uptake and consumption have fallen.

In-person single session educational programs (SSEP) have been suggested as a solution for short-term treatment for people on the waitlist for eating disorder treatment. However, these programs are resource-intensive, as they are usually delivered by an experienced clinician. To overcome this barrier. We have developed and preliminarily validated a rule-based chatbot (a computer program that uses artificial intelligence to have human-like conversations) to deliver elements of the SSEP. The current randomised control trial aims to evaluate the effectiveness of an online single session educational program (SSEP) delivered by a chatbot for people aged 16 and above on the waitlist for eating disorder treatment in Australia. It is hypothesized that participants who engage with the online SSEP will experience improvements in their eating disorder symptoms, overall mental health, psychosocial impairment due to eating disorder symptoms, and motivation for treatment, compared to participants who receive no treatment while on the waitlist.

The primary purpose of this study was to test the hypothesis, through a e-health feasibility study (Study 2), that the Prenatal Mindfulness Relationship-Based (PMRB) program could enhance the mental health of pregnant and new mothers as measured by multiple dimensions of psychological health and the relationship with their infants during pregnancy and postpartum, with positive impacts on gestation, birth and infant outcomes as reported by the mothers in a Post-Birth Questionnaire. The study also aimed to provide further information, based on available literature, about the influence of maternal interoception (embodied awareness) on maternal mental health, in particular depression, anxiety, and stress, mindfulness, and mother-infant relationship during pregnancy and post-birth, in particular emotional availability, which can contribute to the development of mind-body approaches to pregnancy healthcare.This study addressed the following research questions (RQ): RQ1: Would participation in the PMRB program lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline? RQ2: Would participation in the PMRB program lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth? RQ3: Open-ended - “How has the PMRB program supported (or not supported) you during pregnancy, labour and birth and the first postpartum trimester?” The specific hypothesis are: 1) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline; 2) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth; 3) The PMRB program would support women during their pregnancy, labour and birth, and the first postpartum trimester.

The purpose of this study is to evaluate the safety and feasibility of the FloStent implant for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in adult men. Who is it for? You may be eligible to participate in this trial if you are a male aged 45 years or over with lower urinary tract symptoms due to benign prostatic hyperplasia. Study Details Eligible participants will be scheduled to undergo a minimally invasive procedure to implanted with the FloStent. Participants will be required to attend up to 7 visits over the course of 12 months monitoring the FloStent position and lower urinary tract symptoms. Participants can choose to remain in the study for an additional 4 years after the 12 months for long term follow up. It is hoped that the findings of this trial will establish the benefits of this devices for males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia.

This project aims to test and implement a multicomponent intervention ("No More Shame") comprising a screening tool, online training, and a site champion, for sub-acute health providers, who work with older people in sub-acute care settings and may be in a position to identify and respond to elder abuse. The training and screening tool were both developed using co-design methods. The training comprises modules focused on: identifying elder abuse; drivers and risks factors of elder abuse; screening for elder abuse, and management of elder abuse. The impact of the multicomponent intervention on sub-acute health providers' recognition, response, and referral of elder abuse will be assessed via a cluster randomised controlled trial. Key objectives of this project are to: a) improve health providers' ability to recognise, respond to, and refer cases of elder abuse. b) improve older people's sense of safety and quality of life. c) determine what further refinements the multicomponent intervention requires to support national implementation. d) evaluate the cost-effectiveness of the multicomponent intervention.

Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUD) for people with period or pelvic pain. The use of IUDs globally is increasing, however some people experience increased pelvic pain in the 3-6 months following insertion, causing them to have the device removed. They then miss out on the benefits that IUDs can provide, such as; reducing your lifetime exposure to synthetic hormones; decreasing the amount of blood loss at each period; as well as decreasing intense period pain, over time with continual use. Alyra Biotech Pty Ltd has developed and patented a novel IUD designed to reduce the severity of post-insertion pain in those that experience it, giving them access to the benefits of IUD use. The objectives of this study are: 1. To determine how the device performs at releasing the appropriate medicinal drugs (pharmacokinetics). 2. To compare the tolerability of the new Alyra device with the currently approved for use in Australia, the Mirena 'Trademark" device. 3. To determine how much of the medicinal drugs are remaining in the device at study end. 4. To determine the effects of the Alyra Device on the endometrium using endometrial biopsies.

This research study aims to investigate and establish the feasibility, clinical accuracy of remotely-performed, robot-assisted ehocardiographic examination (echo) performed by cardiac sonographers.

SYNERGY -A synergistic research program, incorporating advanced neuroimaging, genetics and liquid biopsy, enabling fetal and newborn diagnosis, prognosis and prediction of treatment responses to prevent, treat and cure CP using precision-medicine interventions. Prevention in this context means a 40% reduction in the rate of CP, and treatment response means a reduction in the size and severity of brain injury, enabling increased function, participation in education, independent living and employment long-term. We propose to do this by bringing together this unique team to: • Accurately identifying the nature/mechanism of the brain injury very early in the fetal or neonatal period, to quantify the location, extent, mechanism and genomics of injury to determine the best prognosis and pathway to precision medicine interventions; • Integrating currently disparate measures of neural injury using cross-cutting research methods across 3 themes involving (1) neuroimaging and EEG, (2) genomics, and (3) liquid biopsy; • Synthesising and converging outputs from themes 1-3 using machine learning (ML) methods to inform theme 4: Translation to precision-medicine trials to prevent, treat and cure CP. • Developing systems to comprehensively monitor how these biomarkers, genomics and precision-medicine interventions impact both the incidence and severity of CP at a population level using our national CP population register (Australian Cerebral Palsy Register, largest country-wide register).