ANZCTR search results

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

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31058 results sorted by trial registration date.
  • Predictors of engagement in mindfulness meditation practice in people with high anxiety

    This study aims to identify predictors of engagement in, and outcomes following, a two-week app-based mindfulness intervention in a sample of adults with high levels of generalised anxiety. On an online platform, participants will complete a cognitive task and questionnaires regarding aspects of their mental health, personality traits and patterns in thinking and behaviour. They will then be asked to use the Smiling Mind app to practice mindfulness meditation daily for the next two weeks. App usage data will be obtained directly from Smiling Mind to gain a measure of participant engagement in the intervention. Psychological predictors of engagement in the intervention (minutes and days of practice) and outcome (pre-post change in generalised anxiety symptoms) will then be examined. It is expected that psychological factors related to the maintenance of generalised anxiety will predict poorer engagement outcomes. Outcomes related to anxiety, depression, stress and worry will be examined from pre to post intervention.

  • Outcomes following an optimised anterior cruciate ligament (ACL) reconstruction rehabilitation program in community-level athletes

    The primary objective of this research is to evaluate the preliminary effectiveness of a pragmatic ACLR rehabilitation program on the ability of patients to meet established return to sport discharge criteria and complete rehabilitation. Patients will complete a 5-phase rehabilitation program that addresses not only the physical deficits associated with ACL injury and reconstruction but also the contextual and patient-related factors which may present barriers to patients achieving return to sport discharge criteria and completing rehabilitation to evidence based standards. All interventions will be delivered at private outpatient physiotherapy clinics across the Gold Coast as part of clinical care. Patients We hypothesise that a pragmatic ACLR rehabilitation program in community-level athletes will be a feasible, clinically, and practically applicable model of patient care, which leads to a higher percentage of patients reaching return to sport discharge criteria and completing rehabilitation.

  • Role of celecoxib in postoperative analgesia in paediatric tonsillectomy: a double-blinded, placebo-controlled randomised controlled trial

    Pain after tonsillectomy is widely recognised to be not fully controlled by current pain management methods, especially in children. The aim of the study is to find out whether the use of the medication celecoxib will be useful in reducing this pain. The hypothesis is that celecoxib will be safe and effective to manage pain in children after tonsillectomy.

  • Nutrition and EXercise Telehealth care for Malnourished older adults post-hospital discharge (NEXT-M)

    This is a pilot randomised controlled trial for recently discharged patients who are malnourished or at risk of malnutrition to receive a combined nutrition and exercise intervention at home. The control group will receive usual care (paper-based patient education materials) whilst the intervention group will receive personalised nutrition and exercise education for a 12 week period delivered by a digital app into their home. The research assistant who conducts baseline and the 12 week assessment will remain blinded to the group allocation. Outcome measures are: recruitment rate, dropout rate, nutrition and exercise adherence, and app engagement. Ten intervention group participants will also be invited to contribute to an interview at the conclusion of the intervention to obtain qualitative information on the app and intervention acceptability. All interviews (approx. 30mins each interview) will be completed using Zoom teleconference. The interview will be audio-recorded, and transcribed by a professional transcription service.

  • Development of small blood vessels in the kidneys of preterm infants

    This study will characterize the development of the small blood vessels in the outermost layer of the kidney after very preterm birth (as early as 24 of 40 weeks of pregnancy) to term and to one year of age, using a new ultrasound mode with the ability to demonstrate blood flow in very small blood vessels (SMI ultrasound). The study will also compare the findings of the blood vessel development with measurements traditionally used to measure the function of the kidneys.

  • Machine Learning to Predict Disposition from Emergency Department Triage

    Background Patients who arrive at the emergency department are triaged by a trained triage nurse, but then may wait hours before being seen by an emergency doctor who decides if they need to be admitted to hospital. Early identification of patients requiring admission from the emergency department may help improve hospital efficiency. Previous research has suggested that machine learning may be able to be applied to triage data to predict if a patient will be admitted to hospital, however no research has been conducted in Western Australia. Objective Use machine learning to predict disposition for patients presenting to the emergency department based on data available at the time of triage. Project plan We will develop our dataset using retrospective triage data from Western Australian Emergency Departments. We will then use a portion of this dataset to train a machine learning model to predict emergency department disposition (such as admitted to ward, intensive care, or discharged). We will test the performance of our machine learning model on the remainder of the dataset and compare the prediction of the best performing machine learning model to the predictions of emergency doctors.

  • Tracheostomy fenestration: Does it increase upper airway flow?

    The purpose of this study is to see if a tracheostomy tube that has a window (called a fenestration) can increase airflow through the upper airway and improve speech when compared to tubes that don't have the window, in patients having surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with a head and neck cancer, and as part of your surgical management have an uncuffed fenestrated tracheostomy in-situ. Study details Patients will be first randomised to either the intervention (fenestrated inner tube) or the control (non-fenestrated inner tube), however all participants will experience both the intervention and the control at some point in time. The interventions will involve changing the inner tubes and seeing an effect on upper airflow. The study will involve several tests, including directly looking at where the fenestration (or, window) sits in the trachea. It is hoped this research will demonstrate that fenestrated tubes can improve airflow and therefore make it easier for patients to speak.

  • The Foot-PAD trial: Effect of a footplate muscle stimulation program on walking capacity in people with Peripheral Artery Disease.

    Peripheral artery disease (PAD) is an atherosclerotic disease characterised by blocked arteries and impaired blood supply to the legs, which causes muscle pain and limits waking capacity and the ability to undertake daily activities. This randomised placebo-controlled trial will test the effect of a novel treatment where patients with peripheral artery disease (PAD) will undertake daily periods of neuromuscular electrical stimulation (NMES) using the Revitive® Medic Coach footplate device. This is a class IIa medical device that is commercially available and approved by the Therapeutic Goods Administration (TGA) for use in Australia. Patients use the device by sitting comfortably and placing their bare feet on the rubber foot pads of the device, which deliver the stimulation to the muscles of the feet and legs. If successful, this simple treatment strategy will reduce symptoms (pain, claudication) and improve exercise tolerance (walking capacity) and quality of life, enabling patients to be more physically active.

  • Why does pain spread? Using touch to treat the spread of pain

    Despite enormous personal and economic cost, chronic (i.e. persistent) pain is too often overlooked. One feature of pain we particularly do not understand is its spread. We hypothesise that the spread of pain reflects an impairment in the way the brain processes incoming sensory information. We will trial a non-invasive tactile (touch) training program, to reduce pain spread in adults with chronic back pain. Crucially - in one of the only longitudinal brain imaging investigations to date - we will scan with electroencephalography (EEG), functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) before and after training so we can better understand the mechanisms of the training and thus more fully harness the potential of this novel idea. We anticipate that the tactile training program, which involves discriminating non-painful two-point stimuli, with feedback, will reduce the spread of pain and will improve tactile function (often poor in chronic pain disorders). Further, we hypothesise that the tactile outcomes will be associated with the EEG and MRI/S outcomes.

  • Mental health and resilience in organised sport: The Ahead of the Game program

    The Ahead of the Game program uses sport to teach athletes, parents, and coaches to talk about mental health, encourage help-seeking, and build resilience. The overall aim of the study is to test the effectiveness and cost-effectiveness of the Ahead of the Game program among a sample of adolescent male sport participants, their parents, and their coaches. In this study we also aim to answer questions pertaining to limits, conditions and mechanisms of program effectiveness – for whom does the program work, under what conditions, and through what mechanisms? Through this study we also aim to replicate and extend a previous controlled trial (ACTRN12617000709347) by using: (i) a stronger research design (i.e., a randomised controlled design); (ii) a longer follow-up period to test the duration of any benefits; and (iii) utilising a more active control group.

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