ANZCTR search results

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

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33587 results sorted by trial registration date.
  • An Investigation into the Clinical Performance of the Medacta Masterloc Stem in patients undergoing Total Hip Replacement Procedures

    In a total hip replacement (THR), also called total hip arthroplasty, the damaged bone and cartilage is removed and replaced with prosthetic components. Secondary stability of the femoral stem is a prerequisite to secondary bone ingrowth and proper long-term fixation. Initial or primary stability of uncemented stems depends either on filling the proximal femur with intimate contact between the stem and the anatomic shape of the proximal femur (an anatomic fit) or filling the femoral diaphysis. The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. The stem features a shortened stem length and reduced distal geometry. It is coated, using a proprietary technology, called Mectagrip, with plasma sprayed titanium and hydroxyapatite to to assist with biological fixation. The aim of this study is to assess patient satisfaction and clinical outcomes following placement of a MasterLoc Stem for Total Hip Arthroplasty.

  • Investigating the effect of cryotherapy on the discomfort of sterile water injections

    The aim of this trial is to compare the effectiveness of a vapocoolant (rapidly cooling) spray to a chemical ice pack to usual care for reducing the injection pain experienced by labouring women when water injections are used to manage back pain in labour. Participants will be women in labour at term with a single, head down fetus and requesting analgesia for back pain in labour. Labour back pain occurs in approximately one third of all labours and sterile water injections, which is standard care at all participating sites, has been shown in placebo controlled trials conducted by members of our team, to provide significant pain relief. However, the administration pain experienced by women receiving water injections is significant and in known to act as a deterrent to use. We will randomise eligible women who have elected to have water injections for labour back pain and consent to participate to receive either vapocoolant spray, application of cold packs for 10 minutes prior to injections, or a control group of usual care in which neither the vapocoolant spray or cold packs are used. We expect the study to provide data on the best approach to mitigating the pain of water injections

  • Staying Active with Multimorbidity In Acute hospital (StAMInA) Trial: a randomised controlled trial investigating the feasibility of allied health assistant delivered mobility rehabilitation for patients with multimorbidity in an acute hospital setting

    This randomised controlled trial will investigate the feasibility of an allied health assistant providing mobility rehabilitation (i.e. physiotherapy) for patients with multimorbidity in acute hospital. All therapy will be prescribed by a physiotherapist and will include daily walking, and standing and seated exercises. We hypothesise that it is feasible for allied health assistants to provide mobility rehabilitation for patients with multimorbidity in an acute hospital.

  • The Global QUEST initiative: QUality of life Evaluation STudy: Assessing Health Related Quality of Life in patients receiving medicinal cannabis.

  • Cellulite treatment using the Aveli device: A pilot, feasibility trial.

    This is a prospective, pilot trial with two study groups. Group 1 will undergo cellulite treatment on their thighs with optional buttock treatment with the Avéli device. Group 2 will undergo the combined procedure of Avéli treatment for cellulite with fat grafting on their thighs with optional buttock treatment.

  • An evaluation of playful discipline taught in an attachment-based parenting program

    Attachment-based parent education programs tend to be resource-intensive and have been criticised for giving vague discipline advice to address challenging child behaviour (Solter, 2013; Van Zeijl et al., 2006). Aware Parenting (Solter, 2013) is an attachment-based program that teaches responsive parenting skills including a playful discipline approach to improve child behaviour. Our previous pilot study on Aware Parenting found the approach can be delivered effectively in a single online session (Baltrotsky et al., 2022) and preliminary evidence suggested the program was associated with some improvements in parents' reports of child behaviour and parental efficacy (Baltrotsky et al., 2021). Therefore, the aim of the current study is to build upon these preliminary findings to determine the role of the playful discipline component of the Aware Parenting program. Baltrotsky, K., Grace, S., Bradbury, J., & Doran, F. (2021). Evaluation of a Brief Attachment-Based Parenting Program: Aware Parenting. [Submitted for publication]. Baltrotsky, K., Grace, S., Bradbury, J., & Doran, F. (2022). Parents' Experiences of a Brief Online Parenting Program with Playful Discipline. Child & Family Behavior Therapy, 44(3), 165-184. https://doi.org/10.1080/07317107.2022.2084596 Solter, A. (2013). Attachment Play. Shining Star Press. Van Zeijl, J., Mesman, J., Van Ijzendoorn, M. H., Bakermans-Kranenburg, M. J., Juffer, F., Stolk, M. N., & Koot, H. M. (2006). Attachment-based intervention for enhancing sensitive discipline in mothers of 1- to 3-year-old children at risk for externalizing behavior problems: A randomized controlled trial. Journal of Consulting and Clinical Psychology. https://doi.org/10.1037/0022-006X.74.6.994

  • A study to investigate the pharmacokinetics of subcutaneous administration of cefazolin and meropenem

    There is a small, but emerging body of knowledge demonstrating the safety and efficacy of subcutaneous (SC) infusion of antibiotics. This practice, popularised in France has been successfully implemented at Fiona Stanley Hospital both for in-patients as well as with the Infectious Diseases Ambulatory Care (IDAC) service delivering ceftriaxone, ertapenem and teicoplanin by this route to select patients. In this prospective, single arm cross over study, we aim to extend this experience to SC meropenem and cefazolin which are 2 commonly used antibiotics for severe infections in hospitalised patients. Patients already receiving either meropenem or cefazolin (usually given three times daily) will be followed closely following administration of IV dosing, followed by the same dose administered as a SC infusion. Detailed safety and tolerability assessments will be accompanied by collection of blood to measure antibiotic concentrations to confirm antibiotic exposure is not compromised.

  • Feasibility of routine collection of patient reported outcome measures

    In response to recommendations by the Australian Commission on Quality and Safety in Healthcare and in collaboration with the National Centre for Healthy Ageing Data Platform, there is a plan to implement routine collection of PROMs at Peninsula Health. Since 2020, we have conducted several studies, informed by an evidence-based framework, that have led to the i) selection of an acceptable PROM to be routinely collected across the service and ii) development of a co-designed PROMs collection system and strategy to maximise routine collection. This study is a feasibility implementation study that will be conducted sequentially across two sites, one acute and one sub-acute hospital ward, using an iterative design approach. We aim to determine the feasibility of the co-designed PROMs collection system prior to organisational-wide implementation. Consumer participants will include all patients aged 60 years or older who are discharged to a private residence or residential aged care home during the study period. Patients with cognitive or communication impairments will complete the PROM via proxy (i.e. family member, next of kin, carer completes the PROM on their behalf). In addition to the consumer participants, volunteers who administer PROMs will be recruited to the project to explore their perceptions of the feasibility of the PROMs collection system. The primary outcome will be the feasibility of using the co-designed digital PROMs collection system which will be determined using the following focus areas of Bowen et al.’s framework: Acceptability (e.g. acceptability of the PROM and collection system measured using surveys), demand (e.g. proportion of participants who complete the PROM), implementation (e.g. item completion/completeness of data), practicality (e.g. cost of implementing PROMs collection system), and adaptation (e.g. differences in outcomes between acute and sub-acute wards).

  • Laryngeal oxygen concentration and apnoea time during microlaryngeal surgery using transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) with different oxygen concentrations: A randomised controlled clinical trial

    Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is an oxygen insufflation method that has been widely accepted for both preoxygenation and apnoeic oxygenation. The use of THRIVE in laryngeal surgeries has advantages over endotracheal intubation in providing surgeons with excellent access to the surgical field. Additionally, the main benefit of THRIVE over subglottic or supraglottic manual jet ventilation is absence of movement artefact within the surgical field, humidification of delivered gases and decreased risk of high-pressure injuries from jet ventilation. However, the use of THRIVE at 100% oxygen concentration renders a risk of ignition and fire during laser surgeries. It is therefore necessary to investigate the safety of using different laser-safe oxygenation deliveries. No study has compared desaturation rates, real-time laryngeal oxygen concentration, and vital parameters between different oxygenation deliveries via THRIVE across 100%, 30%, and apneic conditions with rescue jet ventilation. In the present clinical trial, we aim to: 1) Compare apnoea time and real-time laryngeal oxygen concentration between 30% oxygen and apnoeic conditions following pre-oxygenation with THRIVE at 100% oxygen concentration; and 2) Explore patient factors which predict successful application of THRIVE at 100% and 30% oxygenation vs apnoeic conditions during microlaryngeal surgery. Recruited patients indicated to undergo microlaryngeal surgery will be randomly allocated to one of two groups, either Group A: ‘Apnoea Group’ (no delivery of high-flow oxygen, environmental room air oxygen only) or Group B: ‘30% Oxygen Group’ (Delivery of high-flow oxygen at 30% concentration). Both groups will have initial pre-oxygenation at 100% oxygen concentration with THRIVE. Laryngeal oxygen concentration, oxygen saturation data, and vital parameters will be collected during the procedure and will be compared between the two groups.

  • Project LYRIC (Linking Youth to Resources and Interim Care): A pilot test of a brief psychological treatment to bridge wait times for youth mental health services

    In earlier work, we contextually adapted an evidence-based brief treatment for common mental disorders (depression, anxiety) to support adolescents (13-19 years old) who are considering seeking or waiting to access mental health services in Western Australia (WA). This is called the "Help while you wait" intervention. It comprises four structured counselling sessions delivered in an individual format by non-clinicians (e.g. youth workers). The intervention is designed to equip adolescents experiencing mental health difficulties with problem-solving strategies and coping skills to help them manage their mental health while they wait for specialist services. Study Aims: This study aims to initially evaluate the feasibility, acceptability and the appropriateness of the intervention from the perspective of adolescents who receive the intervention and the intervention facilitators. We also aim to explore whether intervention yields clinical benefits for adolescents’ psychological distress, emotional regulation and problem solving relative to usual care. Finally, we will evaluate the feasibility, acceptability, appropriateness, and effectiveness of the training provided to individuals who deliver the intervention. Methods: We will conduct a two-arm randomized hybrid Type 1 implementation-effectiveness pilot trial of the intervention. The intervention will be implemented in youth-focused community services. These services will refer adolescents (13-19 years old) to the research program. We will recruit 80 adolescents who will be randomly assigned in a 1:1 ratio to the intervention or a usual care comparison condition (waiting lists). The intervention comprises four sessions of individual counselling delivered by trained non-specialist providers. Outcomes will be assessed at baseline, six-week, and 10-weeks post-intervention commencement via electronic surveys. Qualitative interviews will be conducted with interventionists, caregivers, and adolescents allocated to the intervention. Primary outcomes will be feasibility and acceptability of the intervention. Clinical outcomes (psychological distress) will be collected as secondary outcomes. Participants assigned to usual care will be offered the intervention after their final follow up assessment. Outcomes: Findings will be used to improve the intervention training, the intervention materials and approach, and the implementation strategies and to inform scale-up and wider implementation of the intervention. Other anticipated outputs include short reports and briefs for providers and policymakers; conference presentations and webinars; and peer-reviewed publications in scientific journals

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