ANZCTR search results

Fifty five percent of all spinal cord injuries result in tetraplegia and with impaired motor and sensory function of arms, hands, legs and respiratory muscles. For people with tetraplegia, restoration of hand and arm function ranks highest of all functional recovery targets, closely followed by improved breathing and coughing. Exercise training is the main treatment for improving upper-limb and respiratory function after spinal cord injury. Emerging evidence from pre-clinical and clinical studies suggest transcutaneous spinal cord neuro-stimulation (TSS), increases spinal cord excitability through increased reflex input. The aim of this study is to explore the efficacy, safety, and acceptability of TSS combined with exercise training for chronic tetraplegia, targeting hand and respiratory function in a multi-centre community-based adaptive Bayesian Optimal Phase (BOP) II trial design across Australia and New Zealand. A BOP trial design allows for early analysis, identifying and ceasing trial arms that prove to be futile to continue. We hypothesise participants with complete SCI may improve in their strength and breathing outcome measures, however, it is not known whether the improvement will reach the pre-determined signal of benefit.

This clinical trial aims to investigate the effectiveness of a Cognitive Behavioural Therapy for Insomnia (CBT-I) program delivered via a smartphone application (called Sleep Ninja®) for improving sleep and mental health outcomes in Australian children (aged 10 to 11 years) with disrupted sleep relative to an active control. A. Primary Aim: To determine whether the Sleep Ninja app reduces insomnia symptoms at post-intervention compared to an active control. B. Secondary Aims: To determine the effects of the Sleep Ninja on depression, anxiety, sleep quality and daytime sleepiness compared to an active control. C. Subsidiary and Exploratory Aims: To examine whether the reduction in depressive symptoms is mediated by changes in sleep, and to explore the possible mediating role of cognitive processes including repetitive thinking, dysfunctional beliefs about sleep and pre-sleep arousal. To explore the emergence of new cases of MDD at the tertiary endpoint. Hypotheses: Participants receiving the Sleep Ninja app, relative to the active control will report: A1: Improved insomnia symptoms at post-intervention (primary endpoint). B1: Improvement in depression and anxiety, daytime sleepiness and sleep quality at post-intervention. C1: In the Sleep Ninja condition, reductions in depressive symptoms will be mediated by improvements in insomnia symptoms. C2: In the Sleep Ninja condition, reductions in depressive symptoms will be mediated by improvements in insomnia symptoms.

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.

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

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.

Studies have shown that medicinal cannabis can reduce chronic pain, neuropathic pain, cancer pain, chemotherapy-induced nausea, spasticity in Multiple Sclerosis, and epileptic seizures in patients. However, the true gauge and extent of how medicinal cannabis affects patients in real-life conditions is not fully understood. To gain a better understanding of the real-life impact of medicinal cannabis, the QUEST study (ACTRN12621000063819) assessed the impact of medicinal cannabis on patients’ quality of life, symptoms, and function. This study, named the Global Quest Initiative, aims to expand on the work done by QUEST, with an additional focus on health economics. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have been identified as eligible to receive medicinal cannabis, have not started any prescribed medicinal cannabis therapy in the previous 4 weeks, or have commenced medicinal cannabis no more than 2 days ago. Study details All participants will be asked to complete a number of questionnaires at the time of commencing medicinal cannabis, and every 1-2 months over a period of 1 year, to measure quality of life, health service use, prescribed medication use, anxiety and depression, fatigue, sleep, pain, work performance, and motor function, depending on the participant’s health indication. The questionnaires will take approximately 1 hour to complete, and will be accessed online via a link emailed to participants. Participants will not receive any treatments or have their treatment altered as part of this study. It is hoped that this study will show that medicinal cannabis improves quality of life, symptoms, and function in chronic pain sufferers and other patients, and is cost-effective for the treatment of these conditions.

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.

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

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.

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).