ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31173 results sorted by trial registration date.
  • Responsible Opioid Use for Hip and Knee Arthroplasty (Opioidhalt II) Study

    Although we like to think that morphine-type (opioid) drugs are strong painkillers that work for all types of pain, the story turns out to be more complicated. Opioids are commonly prescribed for the pain of hip and knee osteoarthritis where there is little evidence to support their effectiveness, yet there is evidence that they increase harms. Despite this risk, an estimated 24 to 39% of patients undergoing knee or hip arthroplasty use opioids regularly while waiting for surgery. Not only is pre-surgery opioid use not very effective for the pain of severe arthritis, but research has shown that regular use is related to worse pain at the time of the operation, more side effects, longer hospital stays and more complications after discharge from hospital compared to patients who don’t use opioids regularly before surgery. Hip and knee replacements are among the most common elective surgeries performed in Australia, with approximately 100,000 hip or knee replacements performed in 2019. This means approximately 30,000 people annually potentially have their joint replacement outcomes undermined by opioid use. The proposed pilot study aims to reduce these opioid-related harms by measuring whether patients are willing and able to reduce their opioid medication by at least 50% while they are on the waiting list for elective hip or knee replacement. Those patients who agree to participate will be randomized to either a usual waiting list experience or to have a pharmacist work with their General Practitioner to reduce their opioid dose very slowly. Most patients find that their pain does not increase as the doses reduce if tapering is slow and performed in partnership with the patient. Further, individualized tapering supports the patient, provides them with information relevant to their circumstances, and allows them control of the weaning phases. After the patient and pharmacist come to an agreed opioid tapering plan, an Anaesthetist will review this plan to ensure its safety and effectiveness. Whilst the aim is to measure the feasibility of a 50% taper, the patient will decide the point at which they cease to taper. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. Patients already seeing a pain specialist or undergoing opioid tapering will be invited to join an observational group. This research will be performed at both metropolitan and regional teaching hospitals in NSW, in recognition of the increased community use of, and harms from, opioids in regional areas. Patients who present for surgery while taking regular opioids not only have poorer outcomes but also pose a challenge for anesthetists and pain management teams. Thus, the proposed research has the potential to improve the perioperative experience for both the patients and their medical teams.

  • Family Life Skills Triple P for Carers of Young People with Challenging Mental Health Problems: A Feasibility Trial

    The broad aim of this effectiveness study is to conduct a pragmatic randomized controlled two-arm trial (RCT) to determine whether Family Life Skills Triple P plus Group Teen Triple P compared to Group Teen Triple P alone optimizes the parenting and self-regulatory skills, self-efficacy and well-being of parents and carers of young people (12 to 17 years) with severe and complex mental health problems. Recruitment will be statewide, and participants may include the parents/carers of young people (12 to 17 years) on the waitlist for Jacaranda Place Adolescent Unit and Day Program and those referred from referring community CYMHS clinics, E-CYMHS, and CHQ HHS Emergency Departments (ED) (where presenting for serious and complex mental health difficulties). Data will be collected at baseline, post-intervention, and 6 months post intervention. Data will include parental self-report measures of family functioning, parenting, self- and emotional regulation, parental self-efficacy, parental assessment of adolescent wellbeing, as well as routine outcome measure (ROM) data recorded in the young persons’ electronic medical record. This is a pragmatic study to assess feasibility and effectiveness of the program in ‘real life’ conditions.

  • An anchor in the storm: the effectiveness of a flexible perspective-taking intervention in supporting the transition to motherhood

    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.

  • The Efficacy and Safety of Deucravacitinib to that of Methotrexate, in Patients with Vulvar Lichen Planus who have Failed Topical Therapy with Potent Corticosteroids: A Randomized Controlled Trial

    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.

  • Monitoring use of inhalational anaesthetic agents in the operating theatre. Can raising awareness and education of anaesthetists influence practice to reduce waste?

    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.

  • The impacts of a single session educational chatbot on people on waitlists for eating disorder treatment

    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 mindful pregnancy and mother-baby relationship project

    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.

  • Early Feasibility Clinical Study of the FloStent™ System

    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.

  • No More Shame: Investigating the effect of changing health providers recognition and response to elder abuse on associated stigma

    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.

  • The Womens wellness through Intrauterine Neuroimmune modulation study: The effect of a new intrauterine device on pelvic pain in women.

    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.

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