ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Fluid status after bowel preparation for colonoscopy: objective assessment and relationship to hypotension under sedation

    This study is important in defining the baseline physiological state of patients presenting for outpatient endoscopy. It has been observed that intravenous fluids do not prevent hypotension in patients who are undergoing endoscopy. One possible explanation for this is that patients are not intravascularly deplete after bowel preparation solution. This study will determine what the rate of intravascular depletion in patients undergoing endoscopy after bowel preparation solution is.

  • The Yoga for Stress Study

    Levels of perceived stress have indeed been found to have increase considerably over the past decades. Chronic stress is considered to be incredibly toxic, resulting in long-term psychological and physiological changes such that maladaptive emotional states, like depression, increase along with inflammation, while immune functioning decreases. Consequently, stress is among the leading causes for the global burden of disease, entailing heavy costs for both health care systems and the private economy. Alongside this “stress-epidemic” the popularity of yoga is growing exponentially. In addition to reported stress relief, Hatha yoga has been suggested to decrease levels of inflammation as advanced practitioners were found to have lower levels of inflammation than beginners (Kiecolt-Glaser et al., 2010). A randomised control trial on heart failure patients suggested that the practice of Hatha yoga significantly lowered inflammation within a two month period (Pullen et al., 2008). While the empirical evidence for the practice of yoga as a therapeutic technique is promising (Chandratreya, 2011), the literature has reported methodological limitations. Such limitations include small sample sizes (insufficient to obtain power); a lack of standardised protocols in conducting interventions (making studies difficult to replicate); and a general lack of the use of biological markers (considered to be more objective than psychological measures alone). In order to be able to definitively conclude that yoga offers a benefit to chronically stressed individuals biomedical studies that are adequately powered, and use standardised protocols, are required. Hence, this investigation has been designed to address the aforementioned limitations in a randomised controlled trial (RCT). A standardised protocol of yoga will be administered for 16 sessions. We hypothesise that yoga participation in the yoga intervention will benefit participants psychologically, physiologically, and biochemically.

  • Self-care retraining following Stroke

    This research aims to determine the feasibility and effectiveness of intensive showering and dressing retraining delivered for 2 weeks in an inpatient rehabilitation unit. Stroke survivors regularly require assistance with completing self-care tasks at their admission to rehab. This need for assistance often continues following discharge and is associated with poor consumer and carer outcomes. Increased intensity of retraining in rehabilitation continues to show improved outcomes for stroke survivors, therefore we want to test the theory that increasing the intensity of self-care rehabilitation will provide improved outcomes. Each participant will have their level of independence in completing the activities of showering and dressing assessed. They will then receive self-care retraining delivered by an occupational therapist (OT) or an allied health assistant (AHA) either 5 days per week for two weeks (trial intervention), or up to twice per week only for 2 weeks which is currently usual care in the rehabilitation units (control intervention). Re-assessment of their ability to independently complete these tasks will then be completed. The level of improvement will be analysed to determine if there is any increased benefit for those undertaking the trial intervention. The research will also establish whether it is possible, practical and safe to deliver this therapy in inpatient rehabilitation, and if patients like or can manage this level of intensity

  • Optimal Duration of Adductor Canal Catheter Infusions for analgesia following Knee Arthroplasty

    There is a wide range of local analgesic techniques available for analgesia following total knee arthroplasty (TKA). In a recent review article, continuous femoral nerve block analgesia has been described as the ‘gold standard’.. A myriad of combinations of these techniques appear in the literature and all have some limitations. Regional anaesthesia techniques provide far superior analgesia to opioid only analgesia following knee arthroplasty. Femoral nerve blocks have previously been considered the gold standard for analgesia however due to the effects on quadriceps strength these infusions have limited patients ability to mobilise and rehabilitate and have thus been of limited duration. Adductor canal block infusions have provided equivalent analgesia to femoral nerve blocks while preserving motor strength. Patients are able to walk independently while these infusions are running with limited pain. This is transforming post-operative care for these patients. We have audited 3 day infusions in this group of patients and found improvements in pain and mobility. We believe that prolonging the infusion duration may provide further benefits to patients. The primary aim of this trial is to assess whether a 5 day ACB infusion is better than a 3 day infusion in terms of quality of analgesia and their walking activity level during the first week following their surgery. Our secondary aims are to evaluate safety of the technique and to ascertain if any benefits are carried over to the 3 month pain, walking level, hip function and satisfaction levels.

  • Post discharge opioid use in surgical patients

    This study will map the pain and opioid analgesia experience of patients following inpatient surgical care in a variety of hospitals in Melbourne, Australia. This study will determine if there is a significant opioid pool in the community which is sourced in the acute care setting along with the pain experience of patients undergoing surgical care. Measurement of current handling is the first step in developing an opioid stewardship program.

  • Evaluation of the Effectiveness of a Mindfulness-Based Change in Cognitive State in Reducing effects of Chronic Uncontrolled Reversible DisEases.

    The aim of the study: Overall Purpose of the research: is to explore scientific basis for preliminary and anecdotal evidence of psychosomatic nature and the pathophysiology of chronic physical diseases and to evaluate a psychological approach to treat physical disease. The primary aim of this study is to assess the effectiveness of a Mindfulness-based program in improving cardiac autonomic nervous stress response in the patients with chronic obstructive pulmonary disease (COPD) and hypertension. The autonomic stress response is measured by measuring heart rate variability (HRV). Statistically significant increase in HRV after the Mindfulness practice compared to after the standard treatment only will be used to measure the effectiveness of the Mindfulness practice. Both the control and intervention will receive their standard treatment for COPD and hypertension. Only the intervention group will receive training in mindfulness practice. Hypothesis: The hypothesis tested in this study is that Mindfulness Practice reduces autonomic stress response in moderate and severe COPD patients and in patients with hypertension. Cohort: Adult male and female participants who are diagnosed to have moderate or severe chronic COPD and hypertension Design: This is a pilot study of a randomised control trial. Phase 1: We intend to recruit 40 moderate and severe COPD patients with uncontrolled hypertension. Half the group will be randomised to attend a weekly mindfulness training program for 8 weeks in addition to their standard treatment. The other half will act as the control group and will receive only the standard treatment. Phase 2: In phase 2, the same study will be expanded to include an additional number of participants based on findings of the pilot study and extended to explore other different non-communicable diseases associated with autonomic dysfunction. The Mindfulness program (MB SMART) Mindfulness program is designed with practices with a specific emphasis on increasing awareness of automatic behaviour following emotional reactivity using the body and emotional awareness. Enhanced awareness of thoughts, emotions and automatic behaviour can reduce psychological reactivity and thereby reduce the autonomic nervous system activity (psycho-neurological sympathetic over-activity). This program is called Mindfulness-Based Self -Managed Auto-Regulation Treatment (MB-SMART).

  • Tranexamic acid use in Total Hip Replacement - beyond blood loss: a randomised clinical trial of efficacy of tranexamic acid in improving postoperative inpatient functional outcomes following anterior total hip replacement.

    Does tranexamic acid use in the perioperative period reduce post operative thigh swelling, improve short term functional outcomes and reduce analgesia use following total hip replacement? The secondary question of whether tranexamic acid use decreases blood loss in the anterior approach to total hip replacements will also be addressed.

  • Examining the effectiveness of two smartphone applications for improving symptoms of insomnia

    Insomnia is considered a public health concern associated with economic burden, reduced quality of life, and poor mental and physical health. Insomnia is characterised by complaints of dissatisfaction with sleep quality or quantity associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. In addition to sleep disturbances, insomnia may be associated with a number of daytime complaints such as cognitive difficulties and mood disturbances, and is often characterised by heightened physiological and mental activation known as hyperarousal. Insomnia can be treated with pharmacotherapy; however, patients often report adverse side effects and a preference for non-pharmacological interventions. Increasing attention has therefore been paid to behavioural and psychological interventions, as well as complementary and alternate medicines such as mindfulness. Mindfulness incorporates awareness, of present experience, with acceptance. Current theoretical models suggests that mindfulness improves insomnia by changing the relationship that individuals have with negative sleep-related thoughts such as "I need 8 hours of sleep to function the next day", and by non-judgmentally observing and accepting spontaneously occurring physical and psychological processes that often inhibit sleep. Uncontrolled and controlled studies have demonstrated the effectiveness of group mindfulness-based interventions in improving self-reported sleep (e.g. Ong, Shapiro, & Manber, 2008; Ong, Manber, Segal, Xia, Shapiro, & Wyatt, 2014). Emerging research has also demonstrated improvements in pre-sleep arousal, insomnia severity, mood, stress, and objectively measured sleep, though the effects of mindfulness on these variables remain less clear. Research to date has not investigated the effectiveness of self-help mindfulness-based interventions for insomnia. Self-help interventions, such as the use of a mindfulness-based smartphone applications, may therefore provide a promising avenue in which to increase the access to, and use of, psychological interventions. Mindfulness-based smartphone applications have become increasingly accessible to the general public, though very few applications have been empirically evaluated and no research to date has been conducted within insomnia . If mindfulness-based mobile applications are found to be effective, the number of individuals obtaining psychological support could increase considerably. The proposed study therefore aims to examine the effectiveness of the mindfulness-based mobile application 'Headspace' for improving self-report and objective measures of sleep, pre-sleep arousal, cognitive performance, mood, and mindfulness skills in those with symptoms of insomnia.

  • KBARS Study: The effect of knee prosthesis design on knee biomechanics during locomotion following knee replacement surgery

    The purpose of this study is to determine if knee movement and muscle activity of patients implanted with a medial pivot prosthesis design is more normal compared to crucial-retaining or posterior-stabilized designs during locomotion.

  • Thioguanine Suppositories For Proctitis

    HYPOTHESES: 1. Topical thioguanine (TG) will improve proctitis as demonstrated by a fall in partial Mayo score DESIGN The study will be Phase 1 open label, observational single centre study assessing the efficacy and safety of TG as a suppository.

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