ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A pilot randomised controlled trial to determine the effect of two designs of partographs, including labour progress lines, on the rate of spontaneous vaginal birth amongst low risk women in labour for the first time: The Partograph Trial

    The aim of this pilot study is to test the procedures for a larger trial that will compare two different tools (partographs) for measuring progress in labour. In particular we aim to achieve a compliance rate of 85% with both the intervention and control arms of the trial. The outcomes will inform any necessary changes to the main study protocol. If no substantial changes are required the data from this pilot study will be incorporated into the results of the main study

  • Can games based professional learning for community sports coaches for the improvement of coaching quality and student outcomes of physical skills and self-perception?

    The aim of this study is to report the effects of a Game Centered Approach professional development program for improving game play abilities, active learning time, athlete enjoyment of training, athlete physical self-perception and athlete perceived motivational climate. The Professional Learning for Understanding Games Education in Sport (PLUNGE into SPORT) program was developed to enhance the coaching skills of community sport based volunteer coaches using a Game Centered Approach in an authentic learning environment. We hypothesized that athletes in the PLUNGE intervention, compared to those in the control group, will display more favorable changes in game play abilities, activity levels during sessions, enjoyment of training, physical self-perception and perceived motivational climate.

  • Comparison of Trunk Muscle Activation on Stable and Unstable Surfaces in healthy Young Adults

    Previous research has found that abdominal muscle activation is greater when core stability exercises are performed on unstable surfaces compared with stable surfaces. The foam roller is one apparatus commonly used to create instability in a transverse plane while performing floor-based exercises to improve abdominal muscle activation. The Oov (http://www.oov.com.au/) is a newly designed apparatus intended to assist the individual in maintaining a neutral spine, whilst also creating instability in both the transverse and sagittal planes; allowing the individual to perform core-strengthening exercises, stretches and mobility activities with correct spinal posture. In comparison to the foam roller, which is unstable in only 1 anatomical plane, the Oov is unstable in two anatomical planes. This increased instability may create greater activation of the trunk muscles, but no research into muscle activation while using the Oov has been conducted. Each participant will perform three tasks: crook-lying (CL), single leg tabletop (TT) and straight leg raise (SLR). These tasks will be performed on a Pilates Trapeze Table under three different surface conditions: flat, foam roller and oov.

  • The evaluation of allogeneic adipose derived mesenchymal stem cells as a treatment for symptomatic knee osteoarthritis, specifically evaluating safety, effects on knee pain, function and structure, and quality of life in knee osteoarthritis patients.

    This study examines the safety and tolerability of Progenza, a stem cell product derived from a single donor, for the treatment of knee osteoarthritis. Progenza is injected once into the knee. There is a 1 in 5 chance of receiving placebo, which contains no stem cells. The study will investigate the effect of Progenza on knee pain, function and cartilage integrity. Quality of life and activity level will also be examined over the course of the study.

  • Ongoing Treatment of Posttraumatic Stress Disorder After Traumatic Injury

    The rationale of the study is to evaluate the efficacy of enhanced monitoring and referral to specialist services as a means of reducing PTSD after traumatic injury. This study compares the relative effectiveness of (a) Enhanced Monitoring and Referral, and (b) Treatment as Usual in reducing posttraumatic stress disorder symptoms. It is hypothesised that Enhanced Monitoring and will lead to greater symptom reduction than Treatment as Usual.

  • A randomised trial of an intervention to facilitate the implementation of school-based practices known to increase students’ moderate-to-vigorous physical activity.

    Many Australian children are insufficiently active to obtain the health benefits known to be associated with physical activity. The school setting provides opportunities for children to develop the skills needed to participate in physical activity. Reviews of school-based physical activity interventions have demonstrated that multicomponent interventions are effective at increasing students Moderate-to-Vigorous Physical Activity (MVPA) levels and Fundamental Movement Skill (FMS) proficiency. Despite this, few trials have been conducted with the aim of implementing effective school-based physical activity programs at the population level. This study aims to assess the effectiveness of an intervention to facilitate the implementation of a school-based physical activity program with proven efficacy – the SCORES program. The study will randomise 64 primary schools across the Hunter New England region to either a 6-month intervention group or a no intervention comparison group. The existing SCORES program will be modified slightly to enable the implementation of the intervention at a population level. The SCORES program includes the following strategies: a) Teacher professional development to deliver quality physical education lessons; b) Development of a school physical activity policy; c) Provision of recess and lunch physical activity sessions; d) Incentives to engage students in physical activity; and e) Parental engagement via newsletters. To facilitate the implementation of the SCORES program, multiple evidence-based strategies will be used including: 1) Executive support; 2) Staff training; 3) Tools and resources; 4) Academic detailing; 5) Ongoing support; 6) Recognition and incentives; and 7) Performance monitoring and feedback. The effectiveness of the intervention will be determined by collecting post-intervention data at 6 months. It is expected there will be: 1) an 11 minute difference between the mean MVPA of intervention group students and control group students, measured via accelerometers; and 2) a 10% difference in the proportion of school teachers that conduct PE lessons in an engaging, motivating and physically active way, measured via observation using the SAAFE checklist. Process and acceptability data regarding the implementation of the SCORES program will also be collected via an online, self-report survey of teachers.

  • Efficacy of a transdiagnostic treatment for excessive worry in youth: A randomised trial of brief Behavioural Activation

    Around 25% of adolescents report excessive and uncontrollable worry and many adult high worriers report that their excessive worry began in late adolescence (Kerts &Woodruff-Borden, 2011). Younger adults (16-29 years of age) report a higher frequency of worry than older adults about school or work, finances and social interactions (Goncalves & Byrne, 2012). Worry functions as a cognitive avoidance response, suppressing images and somatic activation and preventing the individual from emotional processing of fear that is important for successful habituation and extinction (Stapinski, Abbott, & Rapee, 2010). Such avoidance brings initial relief but results in anxiety maintenance. Worry is an essential feature of Generalised Anxiety Disorder (GAD) and is a presenting characteristic across all anxiety disorders and depressive disorders (Starcevic, et al., 2007). Thus, worry presents an ideal target for transdiagnostic treatment that targets the common features across anxiety and depression. To target worry as a transdiagnostic process, Chen et al. (2013) developed and evaluated a transdiagnostic approach targeting avoidance strategies in adult worriers by using Behavioural Activation treatment. Behavioural Activation (BA) was originally developed to address avoidance in depression (Addis & Martell, 2004) and its efficacy has been shown in a number of randomised controlled trials. When applied to worry, BA is expected to break down patterns of anxious avoidance through repeated exposure to goal orientated behaviours. Viewing worry as a form of avoidance, BA encourages clients to identify avoidance patterns and increase alternate behaviours in the face of worry-provoking situations (Chen, et al., 2013). Compared to more complex treatment packages, two key advantages of BA are: 1) it is simpler to deliver (Hopko, et al., 2003); and 2) it is efficacious, even when delivered by mental health professionals with minimal training (Ekers, et al., 2011). This simplicity is especially appealing for treating young people as some researchers have criticised that the “extreme comprehensiveness” of the CBT protocol is a primary problem for youth and recommended a low-intensity intervention (Hollon, Garber, & Shelton, 2005). The effect of BAW on anxiety and depression has been demonstrated in our pilot trial (Chen et al., 2013) within a community sample of adults. Findings revealed that participants who received an 8-week group based BAW showed significantly greater reduction in worry, depression and characteristics such as cognitive avoidance, intolerance of uncertainty and problem-solving orientation than the waitlist. Twice as many individuals showed clinically significant reductions in excessive worry after BAW compared to the waitlist. These results provide promising support for BAW as a practical transdiagnostic treatment for worry. Hence the current project aims to investigate the efficacy of BAW in young people. Recent developments in cognitive models of worry and treatments for youth are mostly based on adult research (Vasey, 1993) and studies have demonstrated the applicability of the cognitive model or processes in adults to youth (Laugesen, Dugas, & Bukowski, 2003). However, differences in cognitive, social, and emotional development between adolescents and adults must be taken into account (Vasey, 1993). The present project will examine whether BAW is superior to a waitlist control condition in improving worry in anxious and depressed youths after an 8-week treatment/waitlist and a 3-month follow-up. We will also compare the effect of BAW vs. waitlist on a series of secondary outcomes (i.e., distress, behavioural activation, intolerance of uncertainty, life impairment).

  • Prewarming of surgical patients to prevent hypotension on induction of anaesthesia

    General anaesthesia, whilst very safe, has some undesirable side effects. Two of these, a fall in body temperature and a fall in blood pressure, are usually very mild and require little treatment. Occasionally, more severe changes can result requiring significant intervention by the anaesthetist. Whilst prewarming of patients prior to surgery is sometimes employed to reduce the drop in body temperature seen with anaesthesia, it is not known whether this warming may also help reduce the fall in blood pressure. Warming patients results in dilation of blood vessels, with some of the circulating blood volume then moving into more peripheral tissues. This is similar to the process that happens under anaesthesia, with the relaxation of blood vessels caused by anaesthetic drugs resulting in lowered blood pressure. This is usually mild and easily correctable with medications and intravenous fluid administered by the anaesthetist, though occasionally can be more serious. This study aims to answer the question of whether prewarming patients may reduce the fall in blood pressure seen with the onset of anaesthesia, due to blood vessels already being dilated, and hence reduce the need for intervention by the anaesthetist.

  • Effect of Gum Chewing on Postoperative Recovery of Gut Function: A Randomised Controlled Trial

    Postoperative ileus (gut stasis) is a common event seen in patients following major surgery involving bowel resection, contributing to significant postoperative morbidity including delayed resumption of nutritional feeding, patient discomfort, prolonged hospitalisation and increased healthcare cost. The economic impact of postoperative ileus in patients following colectomy is estimated at approximately 1 billion US dollars per year in the United States alone (1). Current management is largely supportive with no widely accepted treatment found to be effective in reducing the period of ileus in postoperative patients. Given the scale of potential benefit, the main aim was to conduct a well-constructed trial involving an adequate number of patients to determine whether gum chewing in the early postoperative period does help to reduce duration of ileus, improve patient experience and decrease length of hospital stay. Reference (1): Schuster R, Grewal N, et al. Gum Chewing Reduces Ileus After Elective Open Sigmoid Colectomy. Arch Surg. 2006 Feb; 141(2): 174-6

  • Evaluation of patients’ warfarin knowledge and outcomes following secondary warfarin education (in an outpatient setting) compared with standard inpatient education, as measured by the Oral Anticoagulation Knowledge test.

    This study aims to examine the impact of extra education on patients' warfarin knowledge and anticoagulation control. Who is it for? You may be eligible to join this study if you are aged 18 years or above who has been admitted to the Royal Melbourne Hospital and newly commenced on warfarin. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the standard hospital warfarin education, delivered by pharmacists. Participants in the other group, in addition to the hospital education, will receive an extra hour of warfarin education once they have left hospital. This will be delivered by the primary investigators. All participants will be asked to complete a 20 question multiple choice test to assess their knowledge of warfarin 6 weeks after they have left hospital. We also ask participants for permission to collect their INR data to check their warfarin control. It is hoped that this project will provide guidance as to whether we need to do more to educate patients about their warfarin therapy, or whether the education system we have in place currently is sufficient.

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