ANZCTR search results

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

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31306 results sorted by trial registration date.
  • Examining the effectiveness of two smartphone applications for improving symptoms of insomnia

    Insomnia is considered a public health concern associated with economic burden, reduced quality of life, and poor mental and physical health. Insomnia is characterised by complaints of dissatisfaction with sleep quality or quantity associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. In addition to sleep disturbances, insomnia may be associated with a number of daytime complaints such as cognitive difficulties and mood disturbances, and is often characterised by heightened physiological and mental activation known as hyperarousal. Insomnia can be treated with pharmacotherapy; however, patients often report adverse side effects and a preference for non-pharmacological interventions. Increasing attention has therefore been paid to behavioural and psychological interventions, as well as complementary and alternate medicines such as mindfulness. Mindfulness incorporates awareness, of present experience, with acceptance. Current theoretical models suggests that mindfulness improves insomnia by changing the relationship that individuals have with negative sleep-related thoughts such as "I need 8 hours of sleep to function the next day", and by non-judgmentally observing and accepting spontaneously occurring physical and psychological processes that often inhibit sleep. Uncontrolled and controlled studies have demonstrated the effectiveness of group mindfulness-based interventions in improving self-reported sleep (e.g. Ong, Shapiro, & Manber, 2008; Ong, Manber, Segal, Xia, Shapiro, & Wyatt, 2014). Emerging research has also demonstrated improvements in pre-sleep arousal, insomnia severity, mood, stress, and objectively measured sleep, though the effects of mindfulness on these variables remain less clear. Research to date has not investigated the effectiveness of self-help mindfulness-based interventions for insomnia. Self-help interventions, such as the use of a mindfulness-based smartphone applications, may therefore provide a promising avenue in which to increase the access to, and use of, psychological interventions. Mindfulness-based smartphone applications have become increasingly accessible to the general public, though very few applications have been empirically evaluated and no research to date has been conducted within insomnia . If mindfulness-based mobile applications are found to be effective, the number of individuals obtaining psychological support could increase considerably. The proposed study therefore aims to examine the effectiveness of the mindfulness-based mobile application 'Headspace' for improving self-report and objective measures of sleep, pre-sleep arousal, cognitive performance, mood, and mindfulness skills in those with symptoms of insomnia.

  • KBARS Study: The effect of knee prosthesis design on knee biomechanics during locomotion following knee replacement surgery

    The purpose of this study is to determine if knee movement and muscle activity of patients implanted with a medial pivot prosthesis design is more normal compared to crucial-retaining or posterior-stabilized designs during locomotion.

  • Thioguanine Suppositories For Proctitis

    HYPOTHESES: 1. Topical thioguanine (TG) will improve proctitis as demonstrated by a fall in partial Mayo score DESIGN The study will be Phase 1 open label, observational single centre study assessing the efficacy and safety of TG as a suppository.

  • Supporting the provision of palliative care in the home environment: a proof of concept study

    Families are viewed as a ‘unit of care’ in palliative services, meaning that carers’ needs are identified and addressed in order to further support the welfare of the patient. Practical educational interventions for carers are needed (Bee et al).; however it is not known which educational methods are acceptable and how high-quality information can be delivered at a national level, with limited cost implications. A significant gap in supporting carers is determining how high-quality relevant information can be delivered at a national level, with limited cost implications, using educational methods which are acceptable to carers. This study involves intervention development and an embedded proof of concept study. In this study we aim to: 1. Design an innovative distance-learning educational package (PrECEPt: PalliativE Carers Education Package). Two modules, identified as priorities in the literature (pain and nutrition/hydration), will be developed. 2. Determine ideal content, learning style preferences (e.g. balance of videos/ vignettes/ quizzes), mode of delivery (online/printed), level of detail/complexity. 3. Determine the acceptability and feasibility of the educational package to carer and healthcare professionals 4. To understand the processes involved in delivery of the key components of PrECEPt including: recruitment processes for a full-scale study; data collection procedures/completion rates; queries directed to the hospice from carers involved in the feasibility work. 5. Determine sample size, recruitment and randomisation processes for a definitive trial. We theorise that carer self-efficacy will increase through providing greater information, skills and confidence. We anticipate the education will benefit patients through more competent and supported carers. References Bee, P.E., Barnes, P. & Lucker, K. (2009) A systematic review of informal caregivers' needs in providing home-based end-of-life care to people with cancer. Journal of Clinical Nursing, 18(10), 1379-1393.

  • Effect of varying dietary protein concentration with carbohydrate versus fat on energy intake in healthy adults

    Protein intake has remained relatively stable through the development of the obesity epidemic. The protein leverage hypothesis proposes that a separate and dominant appetite for protein drives excess energy intake when dietary protein is diluted by fat and carbohydrate. We have provided convincing evidence that when the percent protein of the diet is reduced from 25% to 10% by increasing percent carbohydrate and keeping fat constant at 30% lean humans respond by increasing total energy intake. Recent data from a rodent dietary model suggests that intake of protein and carbohydrate is regulated (with protein dominating) but intake of fat is not. If dietary fat is not regulated in humans we would predict that the protein leverage effect will be even stronger if protein and fat co-vary in experimental diets and carbohydrate is kept constant at an adequate level. The aim of the study is to test whether converse changes in fat rather than carbohydrate will accentuate the protein leverage effect in covert trials. To do this we will manipulate the protein to energy ratio of the diet by increasing or decreasing the protein content whilst respectively decreasing or increasing the carbohydrate or fat content on 4 occasions for 4-days.

  • The relative efficacy of cognitive bias modification for interpretation or attention in social anxiety

    This study will examine the relative efficacy of two variants of cognitive bias modification. these are two implicit training tasks (administered by computer), which train interpretation bias and attention bias. These two variants of CBM will be compared to each and then a combined version and a placebo group will also be included. The participants will complete the relevant training prior to a five minute social interaction task where they will be asked to describe why they are a good person. This will be videotaped. We predict that CBM-A will affect the social anxiety reported during the interaction task (rated immediately after the task), whereas CBM-I will affect the anxiety levels immediately after training. Further, we predict that the combined group will have improved outcomes overall (i.e. we predict an interaction effect between CBM-A and CBM-I.

  • Maternal risk for cardiovascular and metabolic diseases subsequent to pregnancy complications - observational study

    There is evidence from around the world that women who suffered from pregnancy complications including preeclampsia (PE) and gestational diabetes mellitus (GDM) and those who delivered a small-for-gestational-age infant (SGA) or had a spontaneous preterm birth (sPTB) are more likely to develop various cardiovascular and metabolic diseases later in life and that these occur at a younger age than in women who had uncomplicated pregnancies. Despite increasing knowledge of the long term risks following pregnancy complications to women’s health, current clinical practice does not include follow up of women after these pregnancy complications. The proposed study is a follow up of women recruited to the Adelaide cohort of the SCOPE study. The SCOPE study is an international, multi-centre, prospective cohort study which aimed to develop screening tests to predict PE, SGA infants and sPTB across different populations. SCOPE recruited 1164 mother-father-baby trios to the Adelaide SCOPE cohort between September 2005 and September 2008. Of the 1164 women who were recruited to the Adelaide SCOPE cohort, 861 had uncomplicated pregnancies, 93 developed PE, 118 had gestational hypertension, 95 normotensive women delivered SGA babies, 69 delivered preterm and 51 had GDM. All women will be contacted 10-11 years after delivery of the first child. Those consenting will be recruited. The women will be screened for cardiovascular and metabolic risk factors,depression and quality of life. Information will be obtained on diet, exercise and general health. The SF12 questionnaire will be used to assess quality of life. The PHQ9 and GAD 7 questionnaires will be used to assess depression and general anxiety. The height, weight and waist circumference will be measured. Blood pressure (BP) will be measured 20 minutes after resting and in the absence of morning caffeine and cigarettes. If the resting BP is >140/90mmHg or if women had experienced a complication in the index pregnancy, the women will be provided a 24 hour ambulatory BP monitor. Hypertension will be diagnosed if >25% of the 24 hour BP records are >140/90mmHg during the day and >120/80mmHg during the night and the average BP over the 24 hour period is >130/80mmHg. A fasting blood sample will be collected to measure glucose, insulin, glycosylated haemoglobin (HbA1c), LDL cholesterol, HDL cholesterol, triglycerides, blood urea, electrolytes, creatinine and uric acid. Women with risk factors will be referred for specialist care if necessary.

  • Use of ultrasound to determine changes in diaphragm mechanics during a spontaneous breathing trial

    Weaning from mechanical ventilation is one of the most common activities undertaken in intensive care. Currently, the gold standard for weaning and assessing for extubation is a spontaneous breathing trial (SBT). There is still a proportion of patients (up to 20%) that fail extubation due to recurrent respiratory failure following a successful SBT. Both diaphragmatic ultrasound and electromyography are emerging tools that may have considerable utility in augmenting the decision making process surrounding weaning and extubation. This study will aim to assess diaphragmatic function via ultrasound and electromyographic activity analysis at the start and end of a spontaneous breathing trial. This data should enable the identification of the role of diaphragmatic function in both successful and unsuccessful SBTs. Completing this study will aid in understanding the role of diaphragmatic ultrasound and EMG in ventilator weaning and extubation.

  • Screening for childhood obesity and vascular conditions

    The main pregnancy complications preeclampsia, gestational hypertension, small for gestational age pregnancy (SGA) and spontaneous preterm birth are associated with adverse health outcomes for the mother and offspring. Maternal preeclampsia and gestational hypertension are associated with higher blood pressure in the offspring as early as at 6 years of age and a higher risk for coronary artery disease (CAD) in the offspring in adult life. Emerging evidence suggest that children born SGA or born preterm are also at a similar increased risk. We aim to identify early cardiovascular risk factors including obesity and vascular impairment among children aged 9-10 years. The proposed study includes children aged between 9-10 years from the SCOPE (Screening for Pregnancy Endpoints) study. The SCOPE study was conducted in Adelaide during 2005-2008 and 1164 nulliparous pregnant women, their partners and babies were recruited. Detailed information was collected during pregnancy. Of the 1164 women in the study, 861 had uncomplicated pregnancies, 93 developed preeclampsia, 118 had gestational hypertension, 95 normotensive women delivered SGA babies and 69 delivered preterm. We will invite all children of women recruited to the SCOPE study to participate at age 9-10 years. Data will be collected on diet, physical activity, height and weight. Haemodynamic measures will be done noninvasively as follows. Central blood pressure and augmentation index (an indicator of arterial stiffness) will be measured using the USCOMBP+. Cardiac output and systemic vascular resistance will be measured using the USCOM 1A. Microvascular function will be assessed by Post Occlusive Reactive Hyperaemia method using Laser Doppler. The results of children born after complicated pregnancies will be compared with those of children born after uncomplicated pregnancies.

  • The CONEXT study: COmbining EXergaming with Transcranial direct current stimulation to improve balance in people with Parkinson’s disease.

    Parkinson's disease (PD) is a progressive movement disorder that results in a number of cardinal features; resting tremor, progressive slowness of movement and muscle rigidity. Additionally, and perhaps most debilitating, is postural instability, which generally worsens as the disease progresses. Postural instability is known to affect both static and dynamic balance, and is a contributing factor to falls and near-fall related events. Previous literature has suggested a high incidence of falls in PD (with some reporting a 69% falls rate), which often leads to injuries and the need for hospital admission and/or physical rehabilitation. Although medication is the first point of therapy following diagnosis, such pharmacological therapies do little to preserve or improve postural control. Furthermore, many physical therapies (i.e. physiotherapy) often require on-site participation and exercise prescription to be effective, which is not suitable for people who live in rural areas, and often leads to high drop-out rates. Therefore, there is a need for the exploration of efficacious, non-pharmacotherapeutic methods to improve balance of people with PD from within a home setting to enhance compliance rates. As such, using a single randomised controlled intervention, this project aims to investigate the effects of combining virtual reality exercise gaming (exergaming) with a mobile neurological stimulation technique (transcranial direct current stimulation [tDCS]) to improve the balance, cognition and brain function of people with PD in order to reduce the risk of falls and to enhance exercise adherence.

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