ANZCTR search results

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

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32114 results sorted by trial registration date.
  • The effects of non-thermal plasma on burn wounds: a pilot study

    Non-thermal plasma (NTP) is a relatively new technology that generates charged molecules (ions, and reactive oxygen species) at safe working temperatures of 35-40'C. The charged molecules (free electrons and reactive oxygen species such as Ozone) interact with microbial cellular structures such as DNA and proteins causing intracellular deactivation and injury, which induces cellular death. This cellular destruction occurs independently of any antibiotic process, thereby adding to treatment options for multi-drug resistant bacteria. Based on these findings non-thermal plasma has been applied in a variety of commercial fields including water treatment, sterilisation, and healthcare. Terraplasma Medical GmbH has developed and commercialised a hand-held non-thermal plasma device (Plasma care) for use in chronic wounds. The application of this device in burns has yet to be elucidated. The aim of this pilot study is to examine the feasibility, acceptability and initial efficacy of this device in burn wounds. At total of nine inpatients with <10% total body surface area burns will be recruited. A section of the burn will be treated with NTP with the rest treated with standard therapy. Wounds will be assessed and treated daily, with outcomes compared with standard treatment.

  • pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy and the risk of prolapse occurrence – a randomised controlled trial (REATTACH)

    As per the recommendations from American Association of Gynaecologic Laparoscopists (AAGL) practice report, uterosacral ligament suspension may be performed during laparoscopic hysterectomy to reduce the risk of post-hysterectomy vaginal vault prolapse. Hence, ongoing research into the most effective method of preventing prolapse is warranted, this study aims to evaluate the effect of prophylactic uterosacral suspension at time of laparoscopic hysterectomy on reducing the risk of developing prolapse in the future.

  • Early Reintroduction of Nuts for ImmunothErapy (ERNIE)

    This study is a feasibility study designed to establish the safety and tolerability of a food based multi-nut oral immunotherapy (OIT) protocol in children under 5 years of age in WA, We hypothesize that multi-nut OIT will be a practical approach to desensitising children with multiple nut allergies in this age group. Participants with peanut and/or tree nut allergy will receive multi-nut OIT (almond, cashew, hazelnut, walnut and peanut) for 12 months. Children will otherwise avoid those nuts in their diet to which they are confirmed to be allergic at study entry, while those nuts that were tolerated at study entry can be eaten as desired in addition to the OIT doses. Treatment adherence and adverse reactions will be monitored via a daily electronic diary in addition to regular assessment by study clinicians at each visit and monthly telephone calls. Quality of life data will be collected prior to, during and at end of treatment. After 12 months, all participants will undergo an oral food challenge (OFC) to establish whether they are desensitised to the nuts to which they were allergic to at the start of the study.

  • Evaluating a Group Cognitive Behavioural Therapy Program for Adults with Muscle Dysmorphia

    The primary purpose of the study is to investigate the efficacy of a pilot online 8-week cognitive behavioural therapy (CBT) program for adults with muscle dysmorphia. The outcome measures are: primary (changes in muscle dysmorphia symptoms) and secondary (changes in disordered eating, compulsive exercise, depressive symptoms, and psychological distress). There is no prior treatment research on muscle dysmorphia, but we expect participants to experience some benefit in symptoms over the course of the 8-week program.

  • MOVETech: enhancing the coMpetency and confidence of Older drivers in the use of advanced VEhicle TECHnologies

    Older drivers in Australia drive older cars, have increased crash involvement particularly intersection crashes and are more vulnerable to injuries. Autonomous Vehicle Technology (AVT), such as crash avoidance systems, in-vehicle information systems, and comfort-supporting systems, are available in a range of vehicles and are likely to become standard. They have been shown to promote and enhance safe driving whilst potentially mitigating age-related declines. A recent scoping review found <10% of studies examining AVT examined use by older drivers. The limited evidence to date has shown low usage, awareness, confidence, and competency levels in these safety features amongst older drivers. This may be due to a combination of high self-rated driving confidence in older drivers and the fact that many older drivers use older vehicles which do not feature AVT. Little is still known about how older drivers view these technologies, their convenience and the ability of older drivers to use them correctly in order to promote safety. Studies have shown that compared to no training, any type of training in AVT use is beneficial to driving performance. It is hypothesized that road traffic injuries and fatalities can be reduced, among older drivers, by increasing awareness and competence in use of newer cars with available AVT: Level 0 (warnings and alerts) and Level 1 (driver assistance) and Level 2 (adaptive cruise control and lane keeping assist). This trial builds on a successful pilot study (n=8) of a multi-modal training program involving 1) an interactive classroom session, and 2) an on-road (naturalistic) driving session with a trained driving instructor or driver-trained occupational therapist in a dual-controlled vehicle, developed through an expert panel review process led by the research team in 2019-2020. This project will comprehensively investigate AVT for today’s older drivers, with findings of relevance to consumers, insurers, and policy makers and will inform how to position AVTs to enhance the safety older drivers.

  • SHINE: Sleep Health In Perinatal Care

    Pregnancy and postpartum periods are critical times for the ~300,000 families who welcome a newborn in Australia annually. During pregnancy, ~70% of birthing parents report sleep disturbance, and our pilot data showed that 1 in 3 experience symptoms of insomnia that may require clinical attention. As women cope with these significant sleep disruptions, they may also develop unhelpful sleep-related cognitions/behaviours, which can perpetuate sleep problems well into the postpartum period. The use of Cognitive Behavioural Therapy for Insomnia has been shown to result in significantly reduced prenatal insomnia, and benefits to sleep and sleep-related functioning were evident in a long-term follow up at 2 years postpartum (Bei et al., 2021). However, these evidence-based sleep interventions are not currently part of routine perinatal care in Australia. Therefore the SHINE RCT aims to evaluate the effectiveness, cost-effectiveness, and implementation potential of a scalable CBT-based Healthy Sleep program for the pregnancy and postpartum period to expedite its translation to the wider community. There are 3 specific aims: 1. To evaluate the effectiveness of the CBT program against an active control condition. 2. To conduct a health economic evaluation comparing CBT to usual care, examining (1) whether cost savings from reduced health service utilisation offset the direct cost of the intervention, and (2) if not cost-saving, whether the hypothesised improvements in sleep and daytime functioning are worth the additional cost of the intervention. 3. To explore barriers and enablers to wider implementation to promote future successful implementation and sustainability.

  • Our Recovery – Feasibility of a consumer-led, evidence-based online program for self-management of chronic pain in the community

    Chronic pain affects 20% of the adult population in Australia, and can negatively impact all aspects of an individual's life - physical mobility, mood, sleep, occupational functioning and social activities. Our healthcare system cannot cope with the demand of this chronic illness, and community resources have been under-utilised to date. This project, Our Recovery, draws on the 12 Step Consumer-Led Framework used by the Alcoholics Anonymous movement and translates it into an online, evidence-based support program for individuals with chronic pain. This feasibility trial will randomly allocate adults aged 18-65 into the Our Recovery program, or usual care. Treatment satisfaction as well as pain outcomes will be assessed at 3 months and 9 months after commencement of the program. The primary study hypothesis is that individuals participating in the Our Recovery program will report greater pain self-efficacy, less pain-related disability, greater acceptance of pain and better mood, than those receiving usual care. It is also hypothesized that individuals participating in Our Recovery will take fewer pain medications and be performing more hours at work each week (paid and unpaid) than those receiving usual care.

  • Redesigning care post carpal tunnel release: A comparison of standard care with self-directed hand therapy intervention

    This randomised control trial aims to evaluate outcomes following a) standard care, and b) a multimodal hand therapy management package to deliver acute post-operative hand therapy education and care, guide patient expectations of key milestones in recovery, and highlight ‘triggers’ to help patients identify when and how to access the hospital hand therapy service. We hypothesise targeted, rather than routine referral to HT may allow better allocation of resources with non-inferior patient outcomes.

  • A feasibility trial evaluating a yogic style of breathing (Sudarshan Kriya Yoga) in young people with anxiety and/or depression

    Evidence based services available for young people experiencing anxiety and depressive symptoms in Australia have primarily relied on individual psychological therapy and/or pharmacotherapy. Many young people do not fully respond to these treatments, and there are a range of alternative treatment options that require further evaluation. There is evidence that approaches involving mindfulness meditation and yogic exercise may also be effective. However, there has been limited evaluation of interventions that involve an encompassing yogic practice involving mindfulness meditation, breath work, and yogic exercise. We have adapted a specialised program (Sudarshan Kriya Yoga Campus Happiness Program; SKY-CHP) involving yogic breathing and meditation delivered in a group format that encourages social connection and stress management and propose to examine its feasibility as an intervention for youth depression and anxiety symptoms. The adaptation has involved clinicians who work with young people experiencing anxiety and depression, and young people with a lived experience of these difficulties. The aim of the BREATHE study is to examine whether this adapted novel yoga program is safe, feasible, and acceptable among young people experiencing symptoms of anxiety and/or depression. A secondary aim is to evaluate changes in depression, anxiety, psychological distress, quality of life and wellbeing, functioning, and mindfulness. Exploratory aims will examine changes in resting state electroencephalography (EEG) and electrophysiological markers.

  • Influence of the clock time and light on myopia control contact lens wear

    The research study aims to explore the potential interaction between application time of the day and short-term myopia (or ‘short-sightedness’) control contact lens wear and different lighting conditions. Participants will wear contact lenses and goggles fitted with one of the three different light filters (neutral density filters, blue filters and red filters) during each visit and their eyes will be measured using non-invasive methods at the beginning and the end of each visit.

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