ANZCTR search results

This research study examines new approaches to help people regulate their emotions after brain injury. The objective is to determine whether a technique of biofeedback is useful to assist in emotion regulation. The study is being conducted at the University of New South Wales by Professor Skye McDonald, UNSW, and researchers in her team who work under her supervision. In order to better understand how we can improve emotion regulation difficulties experienced by people with brain injuries, we need to include individuals who have had brain injury in our research. Participants will be asked to attend up to 9 sessions over 2-3 weeks, each of which will take approximately 1-2 hours. Most sessions will take place at the University of New South Wales’ Kensington campus. The first and the last session will assess naturally-occurring changes to heart rate while breathing at different rates. To do this, a flexible belt will be fitted around the waist (to measure respiration) and small electrodes will be placed on the undersides of the wrists and fingers (to measure heart rate and skin conductance). During recording, participants will be asked to perform some computer tasks (such as counting numbers) and watch some short video clips. After the first session, participants will be told whether they have been allocated to immediate treatment or deferred treatment. Immediate biofeedback treatment: Participants will attend six sessions which will also involve monitoring heart rate and breathing. In these sessions participants will be asked to follow instructions on a screen concerning this. Deferred treatment: Participants will be asked to wait two weeks before treatment commences. They will attend a second “assessment” session before commencing. We will ask participants to complete some questionnaires and we may ask a close relative also. We will access information from hospital files to complete our records. The protocol has been approved by the Research Ethics and Governance Office at Royal Prince Alfred Hospital: PROTOCOL X16-0279 & HREC/08/RPAH141 – "Emotion disorders following traumatic brain injury: An experimental approach to remediation"

The aim of this study is to identify an insulin dosing strategy for people with T1D using MDI that will effectively control their blood glucose levels after eating meals high in fat and protein. Participation will involve consuming the same test meal for breakfast, a protein shake and a muesli bar on 4 mornings. Each morning participants will be allocated a different insulin dosing strategy. We hypothesise that increasing the insulin dose by 25% and extending the duration of insulin action by using regular human insulin will optimise blood glucose levels.

The purpose of the TIPS study is to compare the effectiveness of two different interventions given before surgery to see if they improve the time needed to recover after surgery. The two interventions being tested are a ‘carboloading’ drink and pain medication called pregabalin (Lyrica ®). The study aim is to reduce the time needed to recover after surgery. Who is it for? You may be eligible for this study if you are an adult woman who will undergo an operation for ovarian cancer. Study details The study involves randomly allocating participants to two different interventions. Firstly, participants are randomised to receive a carbohydrate drink (Nutricia PreOp Drink), water or no drink before surgery. The drink is to be taken 2 hours before the operation. Secondly, participants are randomised to receive pain medication capsule (pregabalin) or a placebo capsule. The capsule is given by mouth 1 hour before the operation and 12 hours after the first dose. Following routine surgery participants will have to complete some questionnaires and answer some questions about how they're feeling, once discharged from hospital the study team will call them 30 days after discharge to ask some questions about their recovery. It is hoped that the findings from this study may improve women having surgery for ovarian cancers comfort prior to an operation and reducing pain after the operation.

Participants accessed the website from a link provided in the SONA PArticipants pool for 1st year Psychology students at Macquarie University; OR accessed the link from a skin condition related FaceBook site: OR from a paper-based invitation on view at a Sydney-base dermatology clinic. Once accessing the study website interested participants provided informed consent (online) and were then taken directly to complete the online pre-survey. Immediately after completion of the survey, participants were randomly assigned to either the online self-compassion writing condition or the online control expressive writing condition. Each writing activity took 30mins maximum. Immediately following completion of the assigned writing condition, participants then completed the online post-survey.

The aim of this present randomised controlled trial is to assess the possible effects of 16-week consumption of A2 dairy products, versus conventional dairy products, on symptoms of psychological distress in 90 women with low mood. Secondary aims of this study are to assess possible effects from consumption of these two dairy products on symptoms of depression, anxiety and stress; gut symptoms; gut microbiota; body composition; cognition; well-being; health-related quality of life; and biomarkers of inflammation and oxidative stress. Participants will be randomised to receive either the A2 dairy products (A2 skim milk and full fat cheddar cheese) or conventional dairy products (conventional skim milk and full fat cheddar cheese). Participants are to replace their existing dairy products with the study products and consume at least 250ml of the study milk each day. All other dairy products are to be excluded for the duration of the intervention. Participants will complete in-clinic assessments at week 0,4 and 16 and fortnightly online questionnaires at home. It is hypothesised that 16-week consumption of A2 dairy products will be associated with the reduction of psychological distress in women with low mood at the completion of intervention phase, compared to the consumption of conventional dairy products.

This study will compare two types of thermoplastic retainer materials in terms of their survival rate over a 6month period. It is hypothesised that one of these materials will show an improved survival rate when compared with the other. Secondary outcomes to be assessed include occlusal stability and occlusal settling. These outcomes will be assessed for two different wear regimes (ie; Full time vs Full time; Night time vs Night time) to see whether this significantly impacts on the results. If the retainer types deliver similar occlusal stability and occlusal settling results regardless of the wear regime (as previous research has suggested), then it is hypothesised that survival rate may be improved by only having a night time only wear regime. This would then enable the thermoplastic retainers to have a longer lifespan resulting in less cost for patients/practitioners.

Neurofibromatosis Type 1 (NF1) is a genetic disorder that affects around 1:3000 individuals worldwide. Individuals with NF1 present with a number of different clinical features including a high tumour burden, skeletal abnormalities and learning difficulties. However, low muscle tone, muscle weakness and fatigue associated with NF1 are being increasingly appreciated as major burdens of disease. These can lead to significant functional impairment and reduced quality of life in children, particularly when combined with other features of NF1 such as learning and behavioural difficulties. A 2006 study showed that approximately 30% of all children with NF1 had low self-concept for physical abilities, which continued into adolescence. There is strong preclinical evidence and anecdotal patient reports to suggest that daily L-carnitine will lead to significant improvements in muscle function (particularly fatiguability) and quality of life in individuals with NF1. While tumor burden and risk of malignancy can be devastating for affected individuals, musculoskeletal complications such as muscle weakness, scoliosis, and learning difficulties are the most common quality of life burdens in a pediatric setting. L-carnitine supplementation represents a low impact, low cost intervention that could yield major quality of life improvements in a large number of individuals. The hypothesis to be tested is ‘low dose daily L-carnitine supplementation (1000mg, two divided doses) consumed for 12 weeks is safe and feasible, and will improve muscle strength and endurance in children with NF1.

The purpose of this study is to test if supportive text messages help improve women’s mental and physical health after breast cancer treatments compared to not receiving any messages. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer and have completed cancer treatments within the past 18 months. Study details Participants in this study will be randomised (by chance) into two groups. One group of participants will receive four text messages per week at random times and days in addition to their usual care for 6 months. The other group will receive usual care alone for the 6-month period, and will be offered the text message program after that time. A small percentage of participants from each group will also wear an accelerometer on their wrist for 7 days. All participants will complete a number of questionnaires before and after the 6-month period. It is hoped this program will ease women’s transition to managing their health independently after treatments.

The purpose of this study is to determine if physical activity can be safely prescribed for women with metastatic breast cancer. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with metastatic breast cancer. Study details Participants in this study will be randomly allocated to one of two treatment groups: 1) Group one will continue with their usual care and be monitored by researchers over a period of 4 months. 2) Group two will take part in an 8-week physical activity program consisting of 2 supervised sessions per week plus a walking program. All participants will also complete a few fitness assessments and questionnaires. Physical activity may be beneficial for improving quality of life and symptom burden. This study will examine whether a supervised physical activity program is safe and feasible for women living with metastatic breast cancer.

Falls are the primary cause of injury for older Australians and cataract, a very common age-related eye condition, increases risk of having a fall. In the BRIGhT study we will comprehensively evaluate integrated surgical and refractive management through public hospital eye clinics to restore vision and prevent falls. This important project will inform the development of new pathways to access cataract surgery and investment in services for the many older people waiting for cataract surgery.