ANZCTR search results

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

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31108 results sorted by trial registration date.
  • Intravenous iron for treatment of Sub-optimal iron stores in Non-Anaemic Patients presenting for major Surgery

    Iron infusions are a commonly used therapy to correct iron deficiency anaemia (low blood haemoglobin). They are used with increasing frequency in surgical patients with the aim being to optimise a patient’s own blood stores prior to surgery and improve post-surgical outcomes. International guidelines recommend the pre-operative administration of iron to surgical patients who are not anaemic, but have iron stores considered sub-optimal, when substantial blood loss that would result in depletion postoperatively is anticipated. However, this is based on limited evidence, and with uncertain outcomes. This pilot study will examine the feasibility and tolerability of a research protocol to compare outcomes (including recovery of iron stores, exposure to blood transfusion and quality of recovery after surgery) in a group of hospital patients having major surgery. Non-anaemic patients with suboptimal iron will either receive an iron infusion pre-operatively or placebo. Patients will be examined by questionnaire, physiological testing and blood tests post-operatively and at one month after their operation to quantify and qualify outcomes for comparison between these groups.

  • Food from Home Study: Dietary acculturation and heart disease risk factors among Chinese Immigrants in Australia

    Chinese immigrants are at increased risk for obesity and non-communicable disease (e.g diabetes, cardiovascular disease) after migration due to an interacting set of factors, including dietary change, cultural barriers, and genetic predisposition. To better understand the increased risk among immigrants, it is important to consider the dietary shift that occurs when Chinese immigrants move to Australia. The goal of our research study is to understand how and why Chinese immigrants change their dietary habits after migration and what impact these dietary changes have on risk factors for diabetes and cardiovascular disease. We hypothesise that over the two-year observation period there will be 1) evidence of dietary acculturation in Chinese immigrants to Australia; and 2) changes in risk factors for cardiovascular disease and diabetes.

  • Treating depressed Australian workers using an app-based intervention: A randomised controlled trial (Anchored)

    This application is for the purpose of conducting a randomised controlled trial (RCT) of a smartphone-based intervention (Anchored) aimed at reducing depression and promoting mental health and wellbeing within Australian workers. The app has previously undergone pilot testing for feasibility, usability and acceptability. Participants will be randomised to one of two conditions: (1) the Anchored app (a CBT, mindfulness, and behavioral activation-based smartphone app) and (2) a psycho-educational online resource. Post-intervention assessment will occur 30 days after baseline, and follow-up assessment will occur 3 and 6 months after baseline. All assessment will be completed online. Key outcomes include: depression symptoms, anxiety symptoms, stress, wellbeing, resilience, function, burnout, work productivity, and lifestyle elements.

  • Replacement of hospital clinic appointments with telehealth appointments delivered directly to the home for people with cystic fibrosis (CF)

    This project aims evaluate a way of delivering care that allows people with cystic fibrosis to receive approximately half of their outpatient care in their own home. The study will use telehealth, a system where the hospital staff and the patient each log into a video call and all questions and assessments are performed online. By using telehealth, patients will not need to travel, which may lead to increased satisfaction as well as cost savings for individuals and the healthcare system. The study aims to measure how satisfied patients are with receiving care in their own home. The study will also determine the costs to the patient and how much of a burden it is on patients to have their appointments at home compared to travelling to the hospital. This is an important study because, as technology improves and the healthcare system has the ability to provide more care without seeing patients in person, there is a responsibility to carefully study if using technology is beneficial to the patient or if this may be detrimental to the patient. Patients that choose to be part of the study will be randomly divided into two groups. One group, named the ‘usual care group’ will continue to attend the hospital for all of their appointments, this represents no change to their usual care. The second group, named the ‘telehealth group), will attend the hospital for approximately half of their appointments only and will remain home for approximately half of their appointments with the hospital staff conducting the appointment via telehealth.

  • Does cooled radiofrequency ablation improve postoperative pain and function in patients undergoing total knee replacement surgery? A randomized controlled trial.

    This study is a prospective randomised controlled trial investigating whether the use of cooled radiofrequency ablation in total knee arthroplasty improves postoperative pain and postoperative function.

  • The use of Virtual Reality (VR) pain psychology therapy to relieve chronic pain associated with cancer.

    The study aims to evaluate a pain psychology therapy delivered by virtual reality to cancer patients with chronic pain. In addition, to confirm the feasibility and acceptability of VR use in a cancer population. Who is it for? You may be eligible for this study if you are 18 years or older with cancer. Study details Patients will be randomly allocated (50/50 chance) to either the intervention group or the control group. The intervention group will receive 3 x 30min sessions of VR-pain psychology therapy, as timed by a researcher. Each session will allow one module of the VR-pain therapy to be provided. The VR session will occur after the patient has seen their oncologist. The software program will incorporate three pain psychological modules: (1) Patient education on the nature and type of pain, and methods to control pain; (2) Teaching progressive muscle relaxation as a form of arousal reduction therapy; and (3) Guided pain visualisation technique to reduce pain catastrophising, reduce maladaptive response to pain, and improve functional outcomes Participants will be required to answer questionnaires about their quality of life and cancer symptoms at several time points, including, 1 month, 3 months, and 6 months after recruitment. It is hoped this trial will provide greater insight into the clinical effectiveness of the Virtual reality intervention on pain scores and can possibly offer cancer patients an alternative non-pharmacological analgesia.

  • Does sensory mindfulness improve emotional comfort in patients with spinal precautions in emergency departments? A pilot study.

    The Alfred and Emergency and Trauma centre sees in excess of 65,000 patients per annum which includes approximately 8,000 trauma presentations. Close to 40% of these presentations will be admitted to hospital, with a substantial number requiring spinal immobilisation for a period of time prior to spinal clearance. Of these, 20%, (approx. 1500 patients per year ) are admitted to the Alfred emergency short stay unit (SSU). Such patients are often required to lie flat in bed, with direct visual contact with the ceiling of the Emergency Department. These is often no visual stimulation for this group of patients which can lead to agitation, aggression, fear and anxiety, which often results in reduced compliance with spinal immobilisation. This study aims to demonstrate improved emotion comfort among spinally immobilised patients in the emergency department short stay unit by providing sensory mindfulness content using a customised mobile integrated patient controlled immersive audio visual device as a therapeutic tool to facilitate relaxation which has been specifically designed for immobilised trauma patients.

  • Ultrasound guided hamstring block to reduce autologous graft site pain in hamstring tendon anterior cruciate ligament reconstruction

    Trial Objective - To determine the efficacy of the ultrasound guided “hamstrings block” in reducing pain and enhancing quality of recovery following anterior cruciate ligament reconstruction (ACLR) with a hamstring autograft. By doing this study we hope to show that the “Hamstrings block” is effective and provide clinical evidence to support the use of this nerve block in order to optimise recovery and improve patient outcomes in the future. Patients will be randomised to one of two groups. The first group will receive the current standard anaesthetic for ACLRs. The other group will receive the current standard anaesthetic for ACLRs plus the novel “hamstrings block”. This will be performed under general anaesthesia. Post-operatively routine questions will be asked about pain levels and any side effects. We will briefly examine the leg to look for effects of the block by testing sensation and muscle strength. Pain levels and presence of nausea/vomiting will be recorded immediately after the operation, at 1 hour, at 6 hours and 24 hours. Also, before and after the operation we will be asking patients to complete a standardised questionnaire that will help us judge how patients have found the recovery following the operation. We then plan to analyse the results and do a Peer reviewed publication of these results in approximately 12 months time.

  • Changes in Achilles tendon volume in response to different calf exercises among people with midportion tendinopathy and healthy people

    Aim: To investigate acute changes in tendon volume and stiffness following different isometric load protocols among people with Achilles tendinopathy and healthy controls. setting: The proposed study will be conducted in the physiology laboratory located in Clayton campus of Monash University. participants: total number of 42 male participants (21 with midportion tendinopathy and 21 healthy matched), recruited from community. intervention: 3 different isometric protocols with different parameters performed on a custom-built dynamometer. the protocols have different load intensity and duration of contraction. each subject in the 2 groups will perform a single protocol per session and the interval between each session is one week. outcome measures: tendon volume, cross-sectional area, and stiffness will be measured at baseline and immediately following intervention using freehand 3-dimensional ultrasoud. secondary outcome: pressure pain threshold measured at baseline and immediately following interventions. discussion: the study will determine if a specific combination of load parameters could maximize volume changes among people with midportion tendinopathy and healthy controls

  • Influence of rituals on open-label placebo effect in healthy volunteers

    This study will investigate the role of rituals in open-label placebo effect. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on wellbeing and randomly assigned to one of three conditions: no-treatment control, placebo treatment, or placebo treatment taken performing a ritual procedure.

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