ANZCTR search results

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

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32107 results sorted by trial registration date.
  • Effect of personalised music listening on quality of life and cognitive abilities in persons with dementia

    This project will address basic questions regarding the use of daily music listening to improve the quality of life for people with dementia (PWD). It will be the first study to examine the role of how often (and for how long) music listening influences the quality of life of people with dementia using short- and longer-term follow-ups. Sixty participants (with dementia) will be randomly assigned to one of five groups. The groups will include personalised daily music listening with headphones (once or twice daily), audiobook listening with headphones, contemporary music (not personalised), and not wearing headphones or listening to music. All participants will receive their standard care. Expected outcomes include improved quality of life for people with dementia, decreased behavioural disturbances and increased cognitive functioning. This study will examine the effects of listening to personalised music to improve quality of life and behaviour in persons with dementia. We hypothesise personalised music listening will improve the quality of life and behaviour of people with dementia. This hypothesis will be examined by asking the following questions: 1. Does daily exposure of listening to personalised and preferred music via headphones improve quality of life indices in people with dementia? 2. Does daily exposure of listening to personalised and preferred music via headphones reduce the severity and frequency of symptoms (e.g., agitation, anxiety and depression) in people with dementia within residential aged-care facilities? 3. How long after the intervention ceases are any positive outcomes still measurable? Is this period affected by the frequency and duration of the personalised music intervention?

  • Effect of fluid restriction on incidence of delayed hyponatraemia post pituitary surgery

    This study is investigating the efficacy of prophylactic fluid restriction for prevention of low sodium levels after pituitary surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older and are undergoing pituitary surgery for a pituitary tumour (functional and non-functional pituitary adenomas, Rathke’s cleft cyst, craniopharyngioma, other). Study details Participants will be randomly allocated to either a fluid restriction protocol (1L of fluid per day for days 4-9 post-pituitary surgery) or a protocol of no fluid restriction. Blood samples as well as data on hospital readmission rates and adverse events will be collected and analysed. It is hoped that information from this study will help inform future management of pituitary surgery patients and prevention of electrolyte disturbances.

  • Efficacy of individual cognitive rehabilitation for adult cancer survivors: A pilot study

    Some people who have been treated for non-central nervous system cancers experience problems with cognitive function during and/or after treatment. In this project, an education and skills intervention that was previously delivered successfully for this population by psychologists or occupational therapists in small group format (Responding to Cognitive Concerns, ReCog) and individual online format (eReCog) will be adapted for individual face-to-face delivery by appropriate professionals (ReCog-I) and piloted with a small number of people who have been treated for cancer. This research aims to gather initial evidence about whether the ReCog-I program has an influence on perceived cognitive function and mental health in participants who have been treated for cancer.

  • A randomised controlled trial of a wellbeing app in the general public

    This is a 12-week RCT trial involving a 6-week wellbeing program delivered via the app. The trial will recruit healthy adults from the app user base with the aim of measuring the participants’ levels of mental wellbeing over time and determining whether the app is effective at increasing their wellbeing, compared to an active control version of the app.

  • N Acetylcysteine in Bronchiectasis.

    This pilot study aims to examine the anti-inflammatory and clinical effects of oral N acetylcysteine( 2400 mg/day) in bronchiectasis over a 6 week period compared with placebo.We hypothesise it will improve these outcomes.

  • Securing jugular central venous catheters with dressings fixed to a liquid adhesive (Mastisol) in an Intensive Care Unit population: a randomised controlled trial re-thinking evidence-based care delivery

    Central venous catheters (CVCs) placed in the internal jugular vein have been associated with increased risk of central line-associated infection and CVC failure compared to subclavian CVCs. Effective dressing and securement of internal jugular CVCs can reduce the risk of such complications, but dressing and securement is often inadequate due to 'drag' of infusion lines on the CVC and intermittent 'catching' of the CVC lines on other objects. Dressing failure also increases the risk of medical adhesive-related skin injury and central line-associated bloodstream infection due to repeated dressing changes. Mastisol Liquid Adhesive (MLA) is a non-water-soluble gum mastic liquid adhesive designed to improve dressing adherence and integrity. MLA has been shown to not increase bacterial growth and improve dressing adhesion in small studies, but has not been rigorously tested in a randomised controlled trial. The aim of this study is to investigate the effectiveness of MLA in reducing dressing changes, adverse events (e.g. device failure, infection and MARSI), clinician workload and costs associated with IJ CVCs. It is hypothesised that dressings secured with MLA will required changes less frequently, and therefore be associated with less adverse events, lower clinician workload and costs.

  • WHOS Coming Off Buprenorphine: understanding the experience of withdrawing from buprenorphine medication in the treatment of opioid dependence

    The introduction of long acting depot (modified release) buprenorphine subcutaneous injections in recent years is a significant addition to the medication options for the treatment of opioid dependence. These medications are long acting and enable 'once a month' doses rather than daily medication such as sublingual buprenorphine - which are often associated with inconvenience and cost for patients and health services. However little is known about the nature of the withdrawal syndrome that occurs if patients discontinue depot buprenorphine medication. The aim of this study is to describe the profile of withdrawal signs and symptoms in participants discontinuing opioid treatment with a 4-weekly depot buprenorphine formulation, and to compare against the withdrawal profile of a parallel group of participants discontinuing opioid treatment using sublingual buprenorphine. Participants will be monitored over a 16-week admission in a residential rehabilitation unit that assists clients withdrawing from opioid agonist treatment; and participants will withdraw using the buprenorphine formulation they are prescribed prior to the admission (a non-randomised comparison group). The main outcome is opiate withdrawal severity (subjective and objective features) over the course of the admission, with secondary outcomes of cravings, adverse events, general heath, sleep measures and patient experience. .

  • A Randomised Controlled Trial of the Effectiveness of a Media-based Intervention on Intentions to Seek Help for Mental Health Difficulties among Australian Men

    This online randomised controlled trial aims to test the effectiveness of a 4-minute purpose-made intervention video on increasing Australian men's intentions to seek help from others when they are experiencing mental health difficulties, compared with a control video. We hypothesise that there will be a significant change in scores on the General Help-Seeking Questionnaire - Self from baseline (T1) to post-intervention (T2 - after viewing the video) in the group that views the intervention video (intervention group), but not in the group that views the control video (control group). The video takes a well-known song and adapts the lyrics with the intention to encourage men to seek support from others when they are experiencing mental health difficulties. The lyrics focus on how men are typically encouraged to remain stoic, to keep their difficulties to themselves, and to never cry, but encourages them to express their feelings and seek support when they are not coping well. The video focuses on a group of diverse men who meet in a large community hall; it has the appearance of a support group. The video begins with a single man beginning to sing the lyrics to the adapted song; he is gradually joined by others until all men have stood and are taking part in this spontaneous 'choir'. The video ends with the call to action printed on the screen 'When the going gets tough. Get Talking' and a link to the study website, which will house information for gaining various types of mental health support. If the video has no negative effects on participants, it will subsequently be released into the public domain and promoted using a largely social media campaign.

  • The effect of a short-term potato-enriched diet on muscle protein synthesis in recreationally active men

    The World Health Organization (WHO) recommends performing both strength/power (resistance-based exercise) and endurance activities (walking, running, cycling, swimming) for wellbeing. Appropriate nutritional support is essential to maximize the beneficial effects of any training program. In this regard, it is well accepted that the ingestion of high quality animal protein (meat and dairy products) as well as specially formulated high-protein bars and drinks have an additive effect in optimizing training-induced increases in muscle growth and strength following resistance-based exercise. In contrast, endurance-based training adaptations are amplified by the ingestion of carbohydrate-rich foods/supplements that rapidly restore muscle and liver glycogen stores and support skeletal muscle remodelling (i.e., mitochondrial biogenesis). Despite their benefits, current trends in consumer preferences driven by environmental factors, health benefits and/ or ethical reasons have brought to the forefront a need to advance knowledge of alternate food and beverage sources beyond conventional products. Vegan dietary practices are characterized by the avoidance of animal-based food ingredients, including dairy products and eggs. Such diets have been associated with a reduced risk of cardiovascular disease and type 2 diabetes. The proportion of individuals choosing to follow a vegan diet has increased in many industrialized nations and trend analysis predicts that their influence on the food sector will continue to grow. While numerous studies have investigated the postprandial muscle protein synthesis response to the ingestion of animal-based (dairy and meat) protein sources, little is known about the muscle protein synthesis response to plant-based proteins. To date, the anabolic properties of such plant-based proteins have only been investigated in limited protein sources. The primary aim of this project is to determine the effect of a non-animal protein diet on rates of muscle protein synthesis consumed during a short-term combined (‘concurrent’) resistance and endurance training program in healthy young males. It is hypothesized that a short-term, non-animal diet in combination with concurrent exercise will increase the synthesis and abundance of individual muscle proteins involved in the responses to both strength- and endurance-based exercise.

  • A pilot trial of a mental health app for Emergency Service Workers: the Build Back Better app

    Our research team has been funded by the Australian Government Department of Home Affairs to provide a suite of integrated mental health resources for individuals affected by the 2019/2020 bushfires (emergency service workers and their families), including an app-based prevention intervention tailored to the needs of this population. This pilot study aims to examine the feasibility of a smartphone application: Build Back Better; in providing evidence-based prevention strategies for anxiety, depression and PTSD for Emergency Service Workers and their adult family. The preliminary effectiveness for whether the intervention leads to any improvement in outcomes such as distress, wellbeing and common mental disorders will furthermore be explored. Participants will complete assessments at baseline and 1 month post- baseline. The smartphone application is intended to be used in a larger scale study aimed at promoting mental health and wellbeing within Emergency Service Workers and their families. The research questions/hypothesis that this study seeks to address are: 1. Explore the engagement with the components the app? 2. Explore the level of satisfaction with the app? 3. Explore the preferences of these individuals in terms of app content, format and design? 4. Explore the preliminary effectiveness in terms of improvements in wellbeing and symptom reduction? These include changes in alcohol and other drug use; self-reported recovery; health-related quality of life and mental health symptoms.

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