ANZCTR search results

The current randomised control trial (RCT) aims to investigate the impact of a single session online intervention aiming to reduce self-harm cognitions and behaviours in young adults aged 18-25. The online intervention (Project SAVE: Stopping Adolescent Violence Everywhere; Dobias et al., 2021) has been previously evaluated with adolescents in the United States, whereby participants are invited to take part in a 30-minute self-administered psychoeducation intervention presented online using Qualtrics software. The online intervention aims to normalise and de-stigmatise feelings of self-hatred and aims to empower young adults to select alternative coping strategies in the face of self-hatred. Participants are randomised to either receive the project SAVE intervention or an alternative online single session intervention called “Share your feelings”, which is a 30-minute self-administered program that uses components of supportive therapy to encourage feelings sharing (Dobias et al., 2021). The current study aims to expand on previous work conducted with adolescents to investigate the impact of project SAVE on decreasing the frequency and likelihood of non-suicidal self-injurious behaviours in young adults, who either report previous month self-harm behaviours and/or cognitions.

Thiamine deficiency manifests as two conditions: cardiac (wet) beriberi, or Wernicke’s encephalopathy. Furthermore, it can potentiate lactic acidosis through failure of pyruvate to enter the Kreb’s cycle. Patients who are malnourished are at risk of thiamine deficiency, and traditionally, replacement is given for patients at risk (patients on TPN without micronutrients, those with history of alcohol abuse, starvation states). Thiamine levels are not routinely checked in usual practice, but instead, supplementation is provided based on risk. The current guidelines give different recommendations (excluding for treatment of beriberi/Wernicke’s, in which the dose is 200-500mg intravenously three times a day for 5-7 days followed by 100mg for 1-2 weeks) 1. For those at high risk of thiamine deficiency, therapeutic guidelines suggests giving 300mg intravenously for 3 days and then 100mg daily for 1-2 weeks 2. In re-feeding syndrome 100mg intravenously for 7-10 days Clinical Question Is 3 days of intravenous thiamine replacement in patients receiving TPN AND at risk of refeeding syndrome, sufficient to restore and maintain thiamine levels when measured at day 7? Hypothesis In patients at risk of refeeding syndrome, thiamine levels are sufficiently restored with 3 days, as opposed to 7 days, of supplementation. Methodology Patients randomized to receive 3 days of intravenous thiamine or 7 days of intravenous thiamine. Standard dose will be given, 250mg b dose forte intravenous. Thiamine levels will be measured at day 0, 3 and 7 to ensure adequate blood levels are reached.

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