ANZCTR search results

This trial will compare three intravenous anti-inflammatory regimens against placebo in women undergoing hysteroscopy and dilatation and curettage (D&C) as a day case surgery. It will compare the effectiveness of pain relief immediately post surgery and during the subsequent 24 hours. It will also compare the incidence and severity of side effects of pain relieving drugs including nausea and itch, and overall quality of recovery from surgery using a well validated questionnaire.

Brief summary: Obstructive sleep apnoea (OSA) is the most common form of pathological breathing in sleep. It is characterised by frequent upper airway collapse, recurrent brief arousals that severely disrupt sleep, and marked repetitive oxidative and cardiovascular system stress. OSA has serious adverse health and quality of life consequences, including severe daytime sleepiness, cognitive impairment, a 2-fold increased risk of motor vehicle and other accidents, and hypertension. Of those patients diagnosed with OSA around 30% exhibit clinically significant symptoms only when supine. Although a number of supine avoidance therapies are available and generally effective (e.g. classic tennis ball devices designed to make supine sleep uncomfortable), all have problems that limit clinical utility. In a follow-up survey of patients established with a traditional tennis ball device, we found that over 90% of patients stopped using treatment within a median time of 1 month, primarily due to excessive discomfort. The acceptability of supine-avoidance therapy as a mainstream treatment for appropriately selected patients relies upon substantiating practical, acceptable and low cost methods to discourage supine sleep. The BuzzPOD (Gorman ProMed Pty. Ltd) is a position monitoring device, worn on the chest, employing a vibration function designed to discourage supine sleep whilst minimally disturbing the patient and bed partner. A previous small, randomised, controlled, cross-over pilot study of active versus inactive treatment (1 week of each with 1 week washout) in 14 patients confirmed that the device almost completely abolished the supine posture and usefully improved OSA severity. Adherence to treatment was high. Total use over the full 3 week trial was (mean+/-SD) 85%+/-23% of nights, 6.8+/-2.3 h per night including zero hours when not worn, and 8.0+/-1.2 h on nights when worn. These average nightly compliance values are around twice those typically reported for CPAP treatment in mild OSA (3.5+/-2.1 h/night). Compliance was maintained at that level for several months in several of the patients who agreed to a longer period of post-study surveillance. Thus, we believe there is now sufficient evidence to support a more rigorous longer-term trial of supine-avoidance therapy. The study intends to recruit 140 patients with supine-predominant obstructive sleep apnoea. Patients will receive both treatments in a randomly allocated order; the control arm will be standard, clinical, best-practice CPAP treatment, the experimental arm will be receive BuzzPOD supine-avoidance therapy. Patients will receive each treatment for 8 weeks, and will attend follow-up assessments just prior to concluding each treatment. It is expected that supine avoidance therapy in patients with positional OSA will achieve improvements in daytime sleepiness and quality of life that are not inferior to those following CPAP, and be better tolerated than conventional CPAP treatment.

This study aims to investigate the effectiveness of an interdisciplinary student clinic program for people with chronic disease compared to people who receive an oral health student-led clinic intervention. It is expected that people who receive the interdisciplinary clinic program will have better health and functioning, less disability, fewer hospitalisations, shorter lengths of stay, less ambulance usage and lower health costs than people who attend the oral health program; when people in the groups are matched using similar characteristics such as age, gender and number of comorbidities.

The primary purpose of this study is to compare the relative effectiveness of two different and standardised exercise programs (The Lyn Watson Program and The Rockwood Program) on function and instability specific outcomes as well as strength and scapula measures, on patients with non traumatic Multidirectional Instability of the glenohumeral joint. The hypothesis is that the Lyn Watson program will produce clinically and statistically superior results on outcomes due to the program’s focus on achieving and maintaining scapula control.

Current sleep research in patients with insomnia has indicated the non- pharmacological intervention of neurofeedback (the ability to self-regulate brainwave frequencies) has the capability to successfully enhance sleep parameters. The purpose of this study is to assess the effectiveness of an individualised neurofeedback protocol for optimising sleep in healthy individuals. With sleep believed to be one of the fundamental aspects of recovery and wellbeing, developing an effective non-pharmacological treatment for enhancing sleep has great potential to enhance recovery and everyday performances.

Burns are unfortunately a very common childhood injury. The Burns and Plastics Treatment Centre (BPTC) at the Children’s Hospital at Westmead is the only children’s Burns Unit servicing the children of New South Wales (NSW) and the Australian Capital Territory (ACT). We undertake approximately 3500 burns dressings in our BPTC per year. When a child presents to our BPTC they are given pain medicines and then taken into a treatment room to have their burns dressing done. These can be extremely painful and anxiety provoking, despite medication. We are very lucky that our service has access to a Child Life Therapist (formerly known as a Play Therapist). This therapist provides patient and family education prior to the procedure, distraction during the procedure from the dressing change occurring independently by nursing staff, and ongoing support after the procedure. Many studies have shown that Child Life Therapy or distraction therapy may be useful in reducing pain and anxiety in children. None however have shown its benefits for burnt children. We aim by undertaking this study, to prove that Child Life Therapy is beneficial by reducing pain and anxiety experienced by children during their dressing changes. To do this, we aim to recruit 100 new burns patients, attending our BPTC for the first time, to our study. Approximately half of these patients will have a Child Life Therapist during their dressing change, the other half will not. Patients will be greeted in the waiting room and explained the study. They will then be asked to participate. If they choose to participate, they will then be given their regular pain medications. Whilst the pain medications are taking time to work, the parent/carer will be asked to fill out a survey about what they expect the pain and anxiety will be. The child will then be taken into the treatment room with their parent/carer to have their dressing done. During the dressing a medical person will be in the room, watching the dressing and recording pain and anxiety scores in 5 minute intervals. After the dressing is over, the child if >5 years old, the parent/carer, and the nurse involved in the procedure, will all fill out questionnaires about how painful or anxiety provoking they thought the dressing was. These questionnaires will be age appropriate. This data will then be collected and analysed by our hospital biostatistician. We hope to find that Child Life Therapy is beneficial and support its further use for reducing pain and anxiety associated with childhood procedures.

The aim of this study is to apply the laparoscopic technique (key-hole surgery) to clinical human kidney transplant after successful pre-clinic experiment in the large animal pig model (RA/3/100/1040, UWA). In order to apply this laparoscopic technique safely to the human kidney transplant, The study has also being conducted on human cadaver body to define the ideal ports position. After successful application of laparoscopic technique in some cases of human kidney transplant, the randomised study will be considered in the near future to demonstrate the advantages of this new technique in clinical kidney transplant such as smaller incision, less pain, quicker recovery, shorter hospital stay, better cosmetics and equal graft function in comparison with routine open surgery.

This randomised controlled trial (RCT) aims to assess the effectiveness, acceptability and feasibility of home HIV testing among gay men in Australia. Approximately 350 high risk gay men (including 50 men who report their last HIV test was more than 24 months ago) will be recruited from clinics and community-based sites and randomised 1:1 to one of the two study arms: home HIV testing arm (intervention); or clinic HIV testing arm (control). At enrolment, all study procedures will be explained to the participants and they will be required to sign a written consent form which will cover all data collection activities of the trial. The OraQuick In-Home HIV Test will be used for home HIV testing in this study. It is a rapid self-administered over-the-counter (OTC) test which is used with an oral fluid specimen and provides a result 20 minutes after specimen collection. The test is developed by OraSure Technologies Inc., (Bethlehem, Pennsylvania, United States) and is approved for home use in the United States (US) by the Food and Drug Administration (FDA). It is not yet approved by the Therapeutic Goods Administration (TGA) of Australia, but can be imported to Australia for personal use and research purposes. This is a wait-list control RCT, with each participant followed-up for 24 months after enrolment. After initial 12 months, participants in the clinic HIV testing arm will switch to home HIV testing arm, so that all the participants will have access to home HIV testing in the last 12 months. At enrolment, men in the home testing arm will receive four OraQuick home tests with written and video instructions. Further home tests will be available on request, with a maximum of 12 kits per participant per year. Ongoing support via a 24 hour phone line will be available to men in the home HIV testing arm throughout the study. Men in both arms will have access to routine HIV testing and care at their preferred clinic. Demographic, sexual behaviour and HIV/STI testing information will be collected from participants through a self-administered questionnaire at enrolment. Every 3 months, brief information on HIV/STI tests and the results will be collected through an online self-administered questionnaire. In addition, HIV/STI test results will be collected from clinics attended by the participants during the study period. At 12 and 24 months, these questionnaires will include additional questions to collect information on acceptability of clinic and home HIV testing and confidence on the performance of home HIV test. At the end of study, selected participants will be invited to participate in in-depth interviews to obtain detailed information about their home test experience and influence on sexual behaviour.

To assess the proportion of breastfed infants who are vitamin D sufficient (25 OH vit D > 50nmol/L) in the intervention group (bolus vitamin D dosing) versus the standard daily vitamin D dosing. This will be achieved by measurement of 25 OH vit D levels ; a marker of vitamin D status. This is an open label, single site - hospital based centre Primary: Proportion of subjects at 4 months of age with 25 OH vit D levels > 50nmol/L. Secondary: Total calcium as marker of safety, compliance, clinical markers of vitamin D deficiency Recruitment period: May – Feb 2014. Four month follow up period 1) 400 IU vitamin D daily 2) 50,000 IU at birth only (bolus) Sample size of 70 with 28 in each group + drop out rate. Term breastfed infants born to pregnant women who are found to be vitamin D deficient (25 OH vit D < 50nmol/L) at 35-37 weeks gestation

The aims of the randomized controlled research project are to investigate the effects of five consecutive daily sessions (1 x 30 minute session/ treatment day) of both: 1) transcranial direct current stimulation (tDCS) and 2) transcutaneous electrical nerve stimulation (TENS) in improving pain intensity, physical functioning, mental health and quality of life in a chronic pain population awaiting pain clinic intervention. The study also aims to investigate whether prior treatment with consecutive daily sessions of both tDCS and TENS improves the outcomes of pain clinic intervention. Outcome measures and methods that will be used to achieve these aims will include: 1) asking subjects to complete self-reported questionnaires that include questions related to measures of pain, physical function, mental health and quality of life 2) measuring the subject's sensitivity to mechanical, electrical and thermal induced pain stimuli (i.e. the stimulus intensity will be increased until the subject can confidently perceive that the pain elicited by the stimulus ‘matches’ the level of intensity of their current pain problem) delivered to the subject's dominant hand using a pressure algometer, electric current stimulator and thermal stimulus respectively 3) collecting subject's saliva to assess induced changes to pain related biomarkers using immunohistochemical techniques.