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.
  • Monitoring breathing in children during anaesthesia: The Electrical Impedance Tomography study

    Mechanical ventilation is often required to support respiratory function but it can cause lung injury. This risk is well understood in the Intensive Care Unit setting where mechanical ventilation is often required for long periods of time but the impact of short exposure to mechanical ventilation during anaesthesia is unknown. Some populations, in particular neonates and small infants, are at greater risk of this potential detrimental effect. One of the principal factors related to ventilator induced lung injury is the inhomogeneity of lung ventilation. To evaluate lung homogeneity, imaging techniques are usually used, although these are often invasive, intermittent and time consuming. Recently a new technology, called Electrical Impedance Tomography (EIT), has been developed. EIT is a non-invasive, radiation-free monitoring tool that allows real-time continuous imaging of ventilation at the bedside, measuring the impedance of the thorax through a belt placed around patient's chest. This study will use EIT to define the patterns of tidal ventilation within the chest and determine whether mechanical ventilation during general anaesthesia increases the risk of lung inhomogeneity in neonates and small infants. We also hope to determine if there is a correlation between the degree of lung inhomogeneity and different aspects of mechanical ventilation. These results could improve our knowledge about the impact of mechanical ventilation on the neonatal lung and help us to find best management for neonatal ventilation during an anaesthetic.

  • Weighing Practices in the early stages of inpatient treatment for Anorexia and Bulimia Nervosa

    This study aims to compare different weighing practices in the early stages of inpatient treatment for Anorexia Nervosa and Bulimia Nervosa. Specifically, we aim to compare the benefits of “open weighing” (where patients are weighed within the therapy session and their weight is then discussed with the therapist overtly) and “blind weighing” (where patients are weighed by the therapist but this information is not shared with him or her). Despite considerable debate about this issue in the literature, to our knowledge, there has been no systematic comparison of patient outcomes following blind and open weighing. Weighing is a key component in the treatment of eating disorders and specific evidence is needed to determine which approach is most beneficial for patients. The current project aims to fill this gap by comparing weighing methods in a specialised inpatient setting. Participants will be randomised to either open weighing or blind weighing. Following consent (assent for adolescents aged< 18 years), participants will be randomised in blocks. The primary outcome variable will be anxiety levels before and after being weighed. Secondary outcomes include rate of weight gain, body and weight preoccupations, tolerance of uncertainty, meal completion and treatment motivation.

  • Tell Your Story: An Online Intervention for Reducing Stigma in Traumatised Refugees

    Refugee men exhibit elevated rates of Post-traumatic Stress Disorder (PTSD), an impairing psychological disorder. Refugee men are also highly vulnerable to the effects of self-stigma, which is associated with a range of negative outcomes, including unemployment and income loss, interpersonal difficulties, decreased self-esteem, and low treatment-seeking behaviour. This project proposes to test the efficacy of an evidence-based online intervention (“Tell Your Story” website) targeting self-stigma for refugee men with PTSD. Refugee men will be invited to take part in the study, recruited via caseworkers at refugee settlement agencies and advertisements within refugee networks, with 200 men expected to enter the study following telephone eligibility screening, information and consent processes. Participants will be randomly assigned to either receive the intervention immediately (intervention condition) or will be placed on an eight week waiting list (waitlist control condition), before access to the intervention is granted. From then on participants in the waitlist will go through the same procedure as the intervention group, The ‘Tell your Story” online intervention comprises of twelve short interactive web-based modules, containing short videos, activities and integrated measurement tools. It is available in Tamil, Farsi and Arabic. Community consultants from refugee communities have been involved in the design of the study and intervention and will continue to be consulted throughout the project. Participants will complete pre-intervention, post-intervention (4 weeks after commencing intervention) and follow-up (8 weeks after commencing intervention) measures of self-stigma, help-seeking intentions, help-seeking behaviours, PTSD symptoms and mental health-related quality of life online, with telephone support if required. Please see attached document 'Procedure Diagram' for an overview of study flow.

  • Test reliability of the Brief-BESTest in people with chronic obstructive pulmonary disease

    Balance impairments have been demonstrated in people with COPD. Yet measuring balance and incorporating specific balance training components in exercise training is still not part of common practice in pulmonary rehabilitation. The Balance Evaluation System Test (BESTest) is a reliable and responsive test to detect improvement in balance for people with balance impairments and it covers six balance control systems: biomechanical constraints, stability limits / verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait. Although it has been shown to be a reliable balance assessment tool for people with balance impairments, it can take at least 40 minutes to complete. In response to the limitations of the BESTest, the Brief-BESTest has been developed. It takes less time to complete and requires less equipment which could make the Brief-BESTest more feasible for clinical use. The reliability of the Brief-BESTest has been tested in people with chronic health diseases such as Parkinson’s disease but it has never been tested in people with COPD. Therefore, the aim of this study is to investigate the intra- and inter-assessor reliability of the Brief-BESTest in people with COPD. This is a prospective, single group, interventional study where people with COPD will be recruited from two sites in Sydney – Concord Hospital and Royal Prince Alfred Hospital. All participants will be asked to attend two assessment sessions (in addition to their routine assessment for pulmonary rehabilitation program).

  • A survey on use of supplemental oxygen therapy during pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD)

    Exercise-induced oxygen desaturation is common in people with chronic lung diseases who are not on long-term oxygen therapy. Supplemental oxygen therapy is often used during exercise testing and training in pulmonary rehabilitation programs. However, there are no standard Australian guidelines on the use and prescription of supplemental oxygen therapy during exercise testing and training in this patient population so current practice remains unknown. Consequently, we are interested in investigating the use of supplemental oxygen therapy in pulmonary rehabilitation. The study aims to evaluate the current pattern of prescribing and using supplemental oxygen therapy in pulmonary rehabilitation programs in Australia.

  • Getting back to work: a job resource package for adults with spinal cord injury

    Research indicates a low employment rate among adults with spinal cord injury (SCI) despite many feeling capable of engaging in paid employment. Resuming employment after SCI provides an opportunity to interact with others and has been shown to contribute to general wellbeing and life satisfaction. Though specialist vocational rehabilitation services exist, barriers to accessing these services have been identified. These barriers include (but are not limited to): delays in the timeliness of vocational interventions, transportation and/or financial difficulties, and social stigma. In this context, time-efficient, cost-effective and accessible methods of vocational service delivery present clinical appeal. This includes the use of information and communication technologies (i.e. Internet) to supplement face-to-face rehabilitation. Specific aims will of this study will be to: 1. Develop and evaluate an online vocational resource for working-age adults with SCI. 2. Identify facilitators of, and barriers to, online learning We expect to demonstrate that: 1. Vocational rehabilitation can be applied in an online format 2. Access to online services will facilitate and promote vocational behaviours and, potentially, contribute to positive mental health outcomes.

  • TREAT Journal clubs: “Tailoring Research Evidence And Theory” into allied health Journal Clubs

    The present study aims to evaluate the clinical impact, effectiveness and feasibility of implementing a structured journal club that is Tailored according to Research Evidence And Theory (i.e., TREAT journal clubs) within a group of allied health professionals compared to usual journal club participation. A randomised controlled design will be used with up to 10 existing allied health journal clubs within Gold Coast Health being randomised to receive either the (1) TREAT journal club format or (2) usual journal club format. Questionnaires will be provided across baseline, post-trial and a 6 month follow up to measure impact on clinical practice, individual evidence based practice (EBP) proficiency, satisfaction and sustainability, as well as the use of post implementation focus groups. The project may provide much needed knowledge in the area of how to effectively undertake journal clubs within allied health, potentially leading to greater clinical impact of clubs and enhanced EBP proficiency of clinicians.

  • Measurement and management of swelling after hand burn injury

    Parallel randomised controlled trial of different methods of application of cohesive bandage for the management of hand burn oedema, against a control method of an off the shelf compression glove. Primary outcome measures will be change in oedema as measured by Bioimpedance Spectroscopy and volumetry, which will also be a validation of BIS for the measure of hand oedema in a burns population, Secondary outcomes include hand range of movement, integrity of compression, pressure exerted by compression application technique, and patient self-reported hand function.

  • Pilates for low risk pregnant women

    Pilates is a popular form of exercise for Australian women (Baggoley 2015) during pregnancy, however there is a paucity of evidence for the efficacy, safety and feasibility of the Pilates method for improving outcomes for healthy pregnant women. The Pilates approach to exercise, movement and wellness has growing appeal to women as a form of exercise and relaxation (Baggoley 2015). It is arguably a suitable physical activity for healthy pregnant women because movements and exercises can be tailored to the physiological changes associated with pregnancy including ligamentous laxity and increased joint range of movement (Balogh 2005, Robinson 2007). Pilates is purported to benefit lumbopelvic stability, joint stability and movement, and lower and upper extremity muscular control, strength and endurance (Cruz-Ferreira, Fernandes et al. 2011). For pregnant women, these health benefits may enable them to more easily adopt active birth positions, which may reduce the duration of labour and enhance their experience of birth (Lawrence, Lewis et al. 2013). The objective of this pilot study is to evaluate 1) the safety, feasibility and practicality of Pilates for low risk pregnant women, 2) associations between participating in a Pilates intervention for labour/birth and maternal health outcomes and 3) elucidate women’s experiences and perspectives of participating in a Pilates intervention during their pregnancy. The overall study will include two research phases: 1) feasibility analysis and a 2) quantitative evaluation of therapy outcomes.

  • The Effect of an Axillary Roll During Total Hip Replacement Performed in the Lateral Decubitus Position on Post-operative Shoulder and Neck Pain (The Axillary Trial).

    The AXILLARY project aims to explore the relationship between the use of an axillary roll during surgery performed in the lateral decubitus position and the presence or absence of post-operative shoulder and neck pain. The sample population of this trial will be those patients who meet the eligibility criteria and who are to have an elective total hip replacement at selected site. This project is a randomised controlled single-blinded trial where participants will be assigned to the group who receive an axillary roll, or the group that does not. Patients will then be asked to rate their shoulder and neck pain post-operatively on two separate occasions. The results of this project will provide scientific evidence to support or not support the use of an axillary roll during surgery in the lateral decubitus position.

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