ANZCTR search results

Cognitive Orientation to daily Occupational Performance Approach TM (CO-OP) was developed to support motor skill development of children with motor difficulties. This study is a randomised controlled trial to test the acceptability, feasibility, and efficacy of the CO-OP motor skill intervention program in children with autism and motor difficulties aged 5-10 years (n = 30). Following the initial intake assessment and goal setting (session 1), participants will be randomised to receive either the immediate CO-OP intervention (n = 15) or be waitlisted to receive the CO-OP intervention (n = 15). Families in the immediate CO-OP group will receive the full intervention protocol immediately following the intake session (8*1hr weekly CO-OP sessions – Sessions 2-9), while families in the waitlist group will not receive any active intervention during this first 8 week block, however, they can continue to access any clinical services that they would usually access. After the follow up assessment (session 10 for immediate CO-OP group, session 2 for waitlist group), the waitlist group will complete the CO-OP therapy (sessions 3-10) and attend a follow up assessment session (session 11), It is expected that at the conclusion of the intervention, children undertaking CO-OP will have improvements on the performance and satisfaction of their movement-based goals.

Objectives: To investigate the effectiveness of an online intervention program Learning to Thrive for university students mental health and well-being. Hypotheses: (1) Compared to the control condition, participants in the intervention conditions will show lower levels of anxiety, depression, academic worry, social anxiety, loneliness, trait avoidance, and intolerance of uncertainty, as well as higher life-satisfaction at post-intervention, at three- and six-month follow-ups. (2) The change scores of both behavioural activation, self-compassion and social identification from pre- to post-intervention will mediate the intervention effects on the outcomes at post-intervention, and at three- and six-month follow-ups.

This research project aims to assess the impact of a wound healing technology (NovoSorb® BTM) on the rate of wound healing in participants who need to undergo minor amputation of their foot. A minor amputation is a procedure which is required to be performed when there is infection or damage to the tissue of the foot which is no longer able to be salvaged or healed without surgery. A minor amputation may involve one or more of your toes or a portion of your foot which has become damaged and is not able to be saved or healed without removal (amputation) of the affected tissue. Ischemia is a condition where parts of the body are starved of blood, which provide oxygen and nutrients for survival, in turn resulting in damage to tissue which can result in wounds. Neuro-ischemia is a condition most often suffered by people with diabetes. This condition affects both the large and small blood vessels in your body, which results in ischemia to tissues. In people with diabetes this condition often affects the blood vessels in their feet which can lead to non-healing wounds. This study seeks to test the ability of the NovoSorb® BTM to heal wounds in people with wounds related to neuro-ischemia. NovoSorb® BTM was originally designed for use in healing wounds in burns patients. The technology has proven useful in helping to heal burns wounds for more than 5 years. This technology is a piece of foam which serves as a scaffold for your healing tissue to grow through. The product is applied by a surgeon in a theatre environment and is left in place until your tissue has grown through the foam scaffold. The foam is specially formulated to slowly dissolve as your healing progresses and your tissue gets stronger. The foam is absorbed by your body and is considered safe and non-toxic. We are seeking to assess whether NovoSorb® BTM helps to heal minor amputation wounds faster and with less risk of infection when compared with current practice (standard wound dressings – negative pressure and antimicrobial dressings). Medications, drugs, and devices must be approved for use by the Australian Federal Government. NovoSorb® BTM is approved in Australia to treat wounds.

The study will evaluate the effectiveness of a new interactive online Cognitive Behavioural Therapy program for individuals who experience difficulty with binge eating, named Binge Eating eTherapy or BEeT. BEeT consists of ten, one-hour interactive, multi-media sessions with all core components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring, thought challenging and feared food exposure. The study will examine whether engaging with BEeT results in a significant decrease in individuals' binge eating in those with binge-eating disorder.

Sleep improves the health, well-being and performance of individuals undergoing training, so this study aims to investigate a practical nutritional aid in attempt to improve sleep quality. The impact of diet on sleep is a growing area of research interest, with reports that protein intakes high in tryptophan may benefit sleep, especially for those experiencing sleep complaints. In addition to sleep, the intake of alpha-lactalbumin may improve mood and cognitive performance of an individual. The proposed mechanism by which sleep, mood and cognition are affected is through increases in tryptophan availability to the brain, which can be measured through blood plasma concentrations. The effect of alpha-lactalbumin intake on these measures has not been completed within a trained population with sleep difficulties. Therefore, we are testing the hypotheses that alpha-lactalbumin supplementation in the evening will improve sleep characteristics, mood, and cognitive performance of trained individuals with sleep difficulties.

This project will investigate how VOMS assessments, measured by the Neuroflex®, can identify sleepiness that affects the performance of driving tasks. Your participation in this project will involve visiting the Flinders Health and Medical Research Institute Sleep Health group laboratory (located in the Mark Oliphant Building, Bedford Park) for a 2-hour introductory laboratory visit. You will then be asked to complete 7-days of monitoring of your sleep and daytime activity at home with an activity monitor worn on your wrist before returning to the laboratory. During your experimental laboratory visit you will first undergo an overnight sleep study followed by the next day and night of performance testing until you finish the protocol at 1pm (i.e., 2 nights and 1.5 days in the laboratory)

Substantial persistent pain after major lung surgery remains a significant problem despite new methods of pain control with up to one third of these patients still experiencing pain severe enough to affect their daily living months after lung surgeries. In addition to its effect on the essential daily tasks of living, long term pain is also known to cause mental health problems and lead to long-term opioid dependency further affecting the quality of life of patients and incurring extra cost to the healthcare system. Optimization of the acute pain control immediately after surgery is the single most important factor affecting the development of long-term pain. One of the more recently developed techniques of pain control is a technique called regional anaesthesia whereby local anaesthetic is injected next to the nerves supplying that area of the body with the surgical incision, thereby effectively ‘numbing’ them to reduce the pain felt by the patients. An alternative pain relief technique involves giving a small dose of local anaesthetic, such as lidocaine, directly into the veins of the patient. This method can offer a much more predictable pain relief than a regional anaesthetic technique because it does not require the specialized technical skills to perform and hence it may have a great potential for general use to reduce pain effectively. Nonetheless, administering local anaesthetic agent, such as lidocaine, directly into the blood can still have some rare side effect including drowsiness and changes in heart rhythm and blood pressure. In this study, we aim to compare these two pain relief methods, not only to assess whether one is better than the other in relieving pain, but also whether one is better to allow the patients to recover from surgery.

This observational study aims to investigate the sociodemographic, medical, and intra- and interpersonal characteristics of men with prostate cancer experiencing cognitive changes following hormone therapy. We also aim to examine in-depth the nature and impact of hormone therapy-associated cognitive changes on these men’s and their partner’s lives and the types of cognitive change. This will be compared to individuals with prostate cancer who are undergoing ‘watchful waiting’ or ‘active surveillance', and individuals without prostate cancer. Who is it for? You may be eligible for this study if you are a male aged 18 years or older, with or without prostate cancer. If you have prostate cancer, you may be eligible if you are currently undergoing hormone therapy, or are undergoing ‘watchful waiting’ or ‘active surveillance’. Study details All enrolled participants will be asked to complete a number of questionnaires regarding quality of life, cognition, physical activity, diet, and mental health. It is expected that the online survey will take approximately 20-30 minutes to complete in total. Participants will be required to complete the survey only once. Participants and their loved ones will also have the choice to sign up for an optional interview with a research team member to explore their experiences in more depth. This interview will take around 20-60 minutes. It can be either conducted over the phone or via videoconferencing. Participants will be reimbursed for the interview. It is hoped that with the findings obtained from this study, this information will help clinicians identify patients who may be at risk of cognitive changes from hormone therapy. Moreover, the findings will aid the development of a neuropsychological intervention to support these patients and their families with managing the cognitive changes they are experiencing.

This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of two screening visits, one baseline visit (day 0), and two treatment visits (day +28, and +112;). At the baseline visit, subjects will be randomly assigned to one of three treatment groups. The primary aim of this proposed study is to determine the effects of daily Ergothioneine consumption in older adults (59-79 years of age) on a range of outcomes. Older adults who self-report memory complaints (i.e. subjectively experience impairments in their cognitive function) will be recruited from the general population. Participants will be assigned to receive either 25 mg of Ergothioneine per day, 10 mg of Ergothioneine per day, or a placebo control. The impact of the intervention will be assessed at 0 days, 28 days and 112 days of taking Ergothioneine daily for 112 days. Participants attend all study visits in a fasted state where they will consume a low-GI breakfast after providing blood samples, and prior to their cognitive assessment; the same breakfast meal is then adhered to over subsequent visits. At the screening visits, subjects will provide informed consent and undergo screening procedures to determine eligibility. Study procedures will be completed including vital signs and resting blood pressure, heart rate, respiration rate and temperature check. The height, weight, and BMI will also be assessed, as will CNS-VS test battery, the Prospective-Retrospective Memory Questionnaire, the Leeds Sleep Evaluation Questionnaire (LSEQ), and the Profile of Mood States (POMS) Questionnaire will also be administered. A non-fasting venous blood draw will be completed to collect samples for a chemistry profile, hematology profile, hs-CRP, ergothioneine, telomere length, and inflammatory markers. Concomitant medications/supplements, inclusion/exclusion criteria and any adverse events will be reviewed at each visit .

Tonsillectomy is one of the most common childhood surgical procedures, however the postoperative recovery is often long and challenging for children and their families.. This study aims to investigate if seven days of oral clonidine is able to improve pain management in children post-tonsillectomy, without increasing the risk of postoperative complications when compared to placebo. Hypothesis: clonidine will significantly decrease postoperative parental reported pain scores following tonsillectomy.