ANZCTR search results

Hearing loss is prevalent in later life and associated with increased risk of depression, social isolation, loneliness, mental illness and reduced quality of life. Additionally, the Covid-19 pandemic has brought about restrictions in social interaction and face to face contact, which has further impacted on the social isolation and mental health status of adults, particularly those with hearing loss. Treatment of hearing loss can be relatively simple but traditional hearing aids are expensive and uptake is often sub-optimal. Personal sound amplification products (PSAPs - 'hearables') offer a simple, cost-effective alternative to conventional hearing aids, but no current evidence exists to determine if they improve the psychosocial consequences of age-related HL. Psychological therapies can be effective in treating mental distress in the elderly but factors such as availability of suitably trained therapists, cost and difficulties delivering the therapy in a socially isolated, hearing-impaired population pose challenges. Behavioural activation (BA) is a pragmatic and fairly simple psychological intervention aimed at improving mental health by increasing cognitive, physical and social activities. BA has been shown to be effective in treating depression in the general population but no current evidence exists to determine if BA with or without hearing loss treatment is effective in ameliorating the psychosocial consequences of hearing loss. The proposed project will aim to test if hearing amplification with PSAPs with or without a BA intervention program improves mood, relieves mental distress and social isolation, improves quality of life, and reduces health care costs in older adults with hearing loss. We will utilise a 2x2 factorial design to randomise 240 older adults aged 65 years and older with mild-moderate hearing loss to a 6-month clinical trial of hearing amplification and/or BA compared with an education intervention control group.

Surgical repair of an inguinal hernia is a common procedure in early childhood. The incidence of inguinal hernia’s is inversely related to an infant’s birth weight, gestational age, and is more common in boys. Prematurity (less than 36 weeks gestational age) is identified as a major risk factor for the development of inguinal hernias, with approximately 30% of preterm infants diagnosed with an inguinal hernia. Most preterm infants diagnosed with inguinal hernias in our institution will undergo surgical repair prior to discharge from the neonatal intensive care unit (NICU). It is well documented that preterm infants undergoing general anaesthesia have an increased risk of cardiorespiratory events including apnoea and bradycardia. Respiratory adverse events are common in paediatric anaesthesia and comprise more than three quarters of all critical incidents and half of all unplanned admission to paediatric intensive care unit. While studies have looked at the post-operative apnoeas and the risk associated with apnoea in infants, there are few studies that have explored the respiratory trajectory of these patients undergoing inguinal hernia repairs. In this study, oximetry and apnoeas will be measured both pre- and post-operatively, along with transcutaneous carbon dioxide levels on the night of surgery to investigate the impact of anaesthesia and surgery on these young infants. Particularly, identifying infants at increased risk of respiratory complications through pre-operative continuous pulse oximetry may potentially reduce morbidity and help guide clinicians on the optimal allocation of resources including the length and intensity of post-operative monitoring required, and ultimately the anaesthesia management plan. This is a pilot study to assess the feasibility of investigating the respiratory profile (deviation from baseline SpO2, desaturation events, apnoeas, carbon dioxide levels) in infants (up to 6 months corrected age) undergoing inguinal hernia repair to assess the recovery profile after surgery under general anaesthesia and/ or regional block at Perth Children’s Hospital, a tertiary specialist paediatric centre to inform the planning of a larger trial. The study will also evaluate the rate of participant recruitment and rate of adherence to the protocol.

Pain is extremely prevalent and highly impactful on quality of life. Both acute and chronic pain are routinely treated with paracetamol, non-steroidal anti-inflammatory drugs, monoamine reuptake inhibitors, anticonvulsant agents, and opioids. However, these treatments may have only modest efficacy in the treatment of pain and/or can have significant adverse effects that also interfere with quality of life (e.g., cognitive clouding, sedation, fatigue, weight gain). The high prevalence and high burden of disease associated with pain, combined with ineffectual treatments or treatments with significant adverse effects defines a clear unmet need for new well tolerated and effective therapeutic treatments that are not prone to abuse/misuse. This extends to the management of mild-to-moderate non-palliative pain. Cannabidiol (CBD) represents one such treatment for control of mild-to-moderate non-palliative pain. Three clinical trials and two observational studies demonstrated clear positive effects of chronic CBD dosing regimens on the management of a range of pain indications. This is a first-in-human (FIH) study for the Promethean Health CBD tablet. However, CBD been extensively investigated in human clinical trials at doses ranging from < 10 mg/day to up to 6,000 mg/day. The planned Promethean Health Pty Ltd clinical trial will investigate a total CBD daily dose of 150 mg/day for a period of 30 days. The dose level was selected within the TGA guidance for Schedule 3 registration (16). The 3 times a day dosing schedule was selected based on the half-life of the formulation (approximately 6 hours), with 3 times daily allowing the broadest dosing schedule that can be achieved through waking hours.

Anxiety associated with medical procedures is common with 40-80% of children experiencing perioperative anxiety. Children can experience significant symptoms and postoperative consequences due to perioperative anxiety, including distress and delirium, increased intensity and duration of pain, prolonged hospital stay, behavioural and sleep disturbance and avoidance of medical encounters which often remain into adulthood. The Magic Coat Perioperative Program will be a novel, evidence-based interactive program delivered in an online format and reinforced throughout the hospital journey that aims to promote coping skills and resilience in children. This sequential pre and post intervention prospective cohort clinical trial will examine the impact of an accessible, customisable online resource designed to introduce and build upon skills for communicating and managing anxiety among children in the peri-operative period and improving induction compliance. Primary hypothesis; Children introduced to the Magic Coat Program via the online storybook who have those skills developed and reinforced during their hospital stay will display a significantly smaller increase in anxiety during anaesthetic induction from baseline (Timepoint 1(T1)), compared with conventional techniques for reducing peri-operative anxiety. Secondary hypotheses; Children introduced to the Magic Coat Program via the online storybook who have those skills developed and reinforced during their hospital stay will, compared with conventional methods of managing perioperative anxiety, 1. Display better induction compliance 2. Be less likely to receive a sedative pre-medication 3. Require less postoperative analgesia for comparable interventions (in the 24 hours following surgery) 4. Be less likely to experience postoperative delirium 5. Experience improved parental and child satisfaction with the perioperative experience 6. Less negative behavioural outcomes at 1weeks and 1-month post procedure

Background: Pain is the leading reason for patients to seek health care, accounting for up to 78% of presentations to the emergency department (ED). Appropriate pain management is the key to quality patient care. Despite effective pain management being a major treatment goal, the underutilisation of pain relief in ED remains prevalent. Aims: This study aims to investigate the impact of pain relief being prescribed in the ED and its effect on the pain scores for patients who have been discharged from the ED with a fracture in a long bone. This study will also investigate whether stronger pain relief are prescribed to patients and used following discharge from the emergency department. Participants: patients of age 17 or older with a long-bone fractures discharged from the hospital. Methods: Follow-up phone survey conducted at one week post-discharge from the ED. The survey will include questions about type of analgesia received and/or prescribed, filling of prescriptions, other pain medications used, adequacy of pain relief within the Emergency Department and following discharge, non-pharmacological pain relief, and interference with activities of daily living and side effects. Expected outcomes: 1) To improve understanding of analgesia prescribing practices of patients discharged from the emergency department within the NSLHD. 2) To improve care of patients with long-bone fractures with improved clinician and nursing awareness of severity of pain and analgesia.

The Triple E study aims to test four strategies for increasing teenagers' use of and engagement with health apps to find out which strategy, or combination of strategies, works best. The app used in the study is called the Health4Life app and is designed to help teenagers improve the 'Big 6' health behaviours that prevent the development of cardiovascular diseases in later life. These health behaviours include, healthy eating, physical activity, sleep, limiting screen time, and avoiding alcohol and tobacco. The strategies tested in the study to improve uptake of and engagement with the app include gamification, access to a health coach, providing health factsheets to parents of the teenage in the study, and text message prompts. It is hypothesised that each of the strategies will be associated with greater app uptake and engagement. No hypothesis is made as to which combination of strategies will be feasible and acceptable, nor which combination will be associated with the greatest uptake and engagement. The study also aims to test whether the uptake and engagement strategies are associated with improvements in participants' 'Big 6' health behaviours. No hypothesis is made as to whether there might be associations between the strategies and participants’ health behaviours.

Mild traumatic brain injury (mTBI) results in a range of debilitating symptoms including cognitive, sensory, and emotional deficits, sleep disturbances, and headaches. Despite increased awareness of the socioeconomic costs and risks of poor outcome, the clinical management of mTBI remains notoriously difficult because there are still no evidence-based interventions for individuals across the lifespan. Current treatment options for mTBI are sparse and not evidence-based, with the standard treatment for mTBI still being rest until asymptomatic. Initial studies led by members of our team have identified subthreshold aerobic exercise as a promising intervention for mTBI in adolescents. Findings from these studies show that this intervention may result in faster recovery and reduced incidence of persisting post-concussion symptoms; thereby allowing individuals to return to per-injury activities sooner. This intervention protocol is also straight forward and applicable in a vast range of clinical setting. However, studies are now required to extend and validate this subthreshold exercise intervention protocol as an effective mTBI intervention in adults. To address this knowledge gap, our complementary and interdisciplinary research team now propose a clinical trial to examine subthreshold aerobic exercise intervention in mTBI patients. We hypothesise that exercise intervention will improve recovery in mTBI patients. Based on these findings we will develop and distribute protocols/guidelines for both adolescent and adult mTBI patients that can be accessed and applied in clinical settings across Australia.

Mycophenolate is an immunosuppressant that is widely used as a treatment for systemic lupus erythematosus (SLE). Its biological effects involve a reduction in immune cell functions, which in turn reduce systemic or organ related inflammation and damage. The benefits of using mycophenolate in SLE need to be carefully balanced against unintended side effects such as increased risk of infection or blunting of vaccine responses. One strategy to counteract these effects is the temporary withdrawal of the immunosuppressant, which allows for the immune system to recover and effectively respond to a vaccine or infection. Our study will examine the effects of withdrawing mycophenolate for a short period in SLE patients. Our hypothesis is that this temporary withdrawal will result in an improvement in the immune responses to the influenza vaccination while maintaining disease control.

We aim to examine the feasibility of a new guided parent-delivered CBT-P (GPD-CBT-P) whose child is aged between 7 and 12 years of age in terms of recruitment through educational settings and retention rates. In addition, we will gather data how GPD-CBT-P performs against waitlist control for change over 18-weeks post-randomisation on self-report (parent and child) measures of perfectionism, stress, depressive symptoms, and body image disturbance. In addition, this will be the first occasion that academic outcomes (satisfaction and self-efficacy) will be examined in a randomised controlled trial design. This is a feasibility trial that will provide a plausible range of point estimates of the efficacy of GPD-CBT-P on standardised continuous symptom measures for our secondary aim. In this way, we can refine the treatment manual and contribute to the design. As a feasibility study we do not pose hypotheses but will examine our primary outcomes (number of enquiries, number recruited into the trial, number completing first assessment, number randomised, number retained in treatment, number of completed assessments at each timepoint, percentage of homework tasks completed between sessions, total hours of guidance used by each family), as well as the perceived treatment credibility, acceptability and effectiveness, and the between group effect sizes (95% confidence intervals) for our measures.

The main purpose of this research is to evaluate the feasibility of a two-week education module designed to inform individuals living with type 1 diabetes how to assess device generated data. This education module has been created by endocrinologists, diabetes educators, industry, dieticians, psychologists, community engagement and education specialists. The researchers will also evaluate participant’s satisfaction with the module and satisfaction in the management of their diabetes, as well as looking at their blood glucose control after the education module. Involvement will last around 26-28 weeks and will involve 7 visits, and at least 4 of these visits will occur at the clinical trial site. Participants will be asked to wear a continuous glucose monitor, and a keep a study diary at specified times over the course of the trial.