ANZCTR search results

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

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31350 results sorted by trial registration date.
  • Australian Father's Study: A longitudinal study of men about to become fathers and their engagement in pregnancy, birth and the early postnatal period.

    Prospective study of 1000 men who are the acknowledged father of an unborn baby. Men will be recruited via their partner. Following informed consent, men are followed across the antenatal period, birth and their involvement in the study concludes six weeks postpartum. Men complete an antenatal, birth and postnatal questionnaires that addresses demographic, engagement, anxiety and depression, quality of life questionnaires and in addition questionnaires specific to each stage (antenatal focuses on pregnancy issues, birth on birth issues and postnatal on issues anticipated to arise in the first six weeks postpartum).

  • Psychological stress, pain management and the development of a stiff, painful shoulder following rotator cuff or clavicular surgery.

    This study aims to find out whether having a depressed mood or inadequate postoperative pain control are associated with the development of a stiff and painful shoulder following shoulder surgery. Surgery to the muscles and tendons (rotator cuff) of the shoulder and surgery to the end of the collar bone (clavicle) are common procedures. However one complication that occurs is the development of a stiff painful shoulder in the first 3 months of the postoperative phase. A number of factors have been associated with the development of postoperative shoulder stiffness. It has been suggested that depressed mood and postoperative pain are associated with the development of postoperative shoulder stiffness but this area has not been studied. The purpose of this study is to look at the relationship between postoperative pain, depressed mood and the development of postoperative shoulder stiffness and determine whether either depressed mood or postoperative pain are important predictors of and possible management targets to decrease the rate of postoperative shoulder stiffness. The study will involve 100 to 200 participants who will all be patients of A/Professor Simon Bell undergoing rotator cuff or clavicular surgery

  • Efficacy of Metacognitive Therapy for Prolonged Grief Disorder: A Randomised Control Trial.

    Recent research has demonstrated that 16% of the bereaved population experience a complicated form of grief called Prolonged Grief Disorder (PGD), that causes extreme disruption to daily functioning (Prigerson, Vanderwerker, & Maciejewski, 2008). Based on these findings, it is estimated that out of the 140,000 deaths registered in Australia per year (Australian Bureau of Statistics, 2012) each conservatively affecting approximately 5 people, around 112,000 people could develop prolonged grief disorder. Despite the prevalence of this disorder, studies of psychotherapy for individuals suffering from the effects of prolonged grief are scarce. The purpose of this research project is to test the efficacy of Metacognitive Therapy on traumatic grief-related effects for individuals with PGD. Male and female participants (N=50; aged 18 or over) will be randomly assigned to either a waiting list or an intervention condition (Metacognitive Therapy), which promotes new ways of relating to their thoughts and beliefs about the loss. Measures of prolonged grief, anxiety, depression, rumination, metacognition and quality of life will be taken pre and post treatment and at the 3-month follow-up for both groups and at the 6-month follow-up for the intervention group. Multi-level mixed effects linear regression will be used to assess treatment efficacy. It is hypothesised that compared to participants in the wait-list condition, the intervention group will have lower levels of PGD symptoms and better quality of life at completion of the study. A greater awareness of the treatments that support the return to pre-loss levels of functioning for bereaved individuals is required.

  • Measuring the effectiveness of a phonological awareness teaching program for the kindergarten classroom

    The Cracking the Code program is designed to target the phonological awareness (PA) skills and alphabet knowledge of kindergarten students (aged 3 years and 6 months to 5 years and 6 months) within the context of classroom based instruction. This study aims to explore the effectiveness of this program in improving; PA, alphabet knowledge and early reading and spelling, when delivered within a Speech Pathologist guided, teacher implemented, intervention structure. Schools will be randomly assigned to either the treatment or control condition. Control groups will participate in an alternative program, targeting alternative language areas. To evaluate the effectiveness of the Cracking the Code program (CtC) (Fremantle Language Development Centre (FLDC) Outreach Service, 2013) the following hypotheses will be tested; 1. Participation in CtC will lead to a significant improvement compared to the control group in PA skills across the levels of syllable, onset-rime and phoneme as measured by the Cracking the Code PA Assessment (FLDC Outreach Service, 2013). 2. Participation in the CtC program will lead to a significant improvement compared to the control group in alphabet knowledge, including the identification of both name and sound of each letter for both upper and lower case representations as measured by an alphabet knowledge assessment. 3. Participation in the CtC program will lead to a significant improvement compared to the control group in early (a) reading and (b) spelling skills as measured by a non-word reading and spelling assessment.

  • An Australian designed, online cognitive behavioural therapy intervention for insomnia: an open trial

    The aim of this study is to investigate the effectiveness of an Australian-designed online cognitive behavioural therapy intervention for insomnia called Sleep-e. Insomnia is a very common sleep problem but many people do not access available treatment. Interventions that are delivered via the internet, such as Sleep-e, can increase the communities’ access to treatment, and improve health outcomes. Participants who are on the waiting list for the Insomnia Clinic at the Heidelberg Repatriation Hospital at Austin Health will be invited to take part in the study. Participants will initially complete a range of questionnaires via the internet about their sleep, and also complete sleep diaries and wear a wrist actigraph watch outlining their current sleep patterns. Participants will then complete a 7 week online program, based on cognitive behavioural therapy for insomnia. Every week, participants will be asked to read one module, complete homework activities based on the module, and also complete weekly sleep diaries. After the program has been completed, participants will be given questionnaires, sleep diaries and the wrist actigraph watch to re-assess their sleep. The time commitment for the program is approximately 1 hour per week over a 9 week period. Upon completion of the program, participants will have their appointment with the Insomnia Clinic.

  • Dignity Therapy in Aged Care:A pilot study to determine feasibility and likely impact on residents and service providers

    Purpose of the study is to assess the usefulness and potential effectiveness of Dignity Therapy in reducing psychological and spiritual distress in newly admitted residents to Residential Aged Care Facilities (RACFs). The study will also assess the impact of the intervention on the service provider and care provision. The intervention entails interviewing residents using a series of guided questions about their past life and events that are important to them and producing an edited document that could be shared with other family members and service providers. A comparison group will receive another intervention (Friendly Visit).

  • High Flow Humidified Nasal Cannula versus Standardised Oxygen Therapy

    This study aims to define which patients will benefit most from the High Flow Humidified Nasal Cannula as apposed to standard oxygen therapy in the acute Emergency department setting. Outcomes which we will be measuring include improved vital signs, length of stay in the Emergency Department, need for escalation to non invasive and invasive ventialtion and patient comfort.

  • A Novel Approach to Real-life Communication: Narrative Intervention in Aphasia

    This project is a randomized control trial that will deliver and evaluate a highly innovative intervention for people with aphasia (i.e. loss of or reduction in the ability to use language) following stroke. Pilot work with the intervention, based around narrative structure and daily communication activities, has been successful in significantly improving language ability in everyday communication. The study will recruit 20 people with aphasia from Royal Perth Hospital and compare the novel protocol to usual speech pathology intervention. Outcomes will significantly refine future intervention with people with aphasia and facilitate translation of theory into routine clinical practice.

  • Comparisons of mercury-free and automated sphygmomanometers with mercury sphygmomanometry in hypertensive and normotensive pregnant women: parallel, prospective, observational study

    Our aim was to find a suitable replacement for mercury sphygmomanometry to measure blood pressure in pregnancy. A mercury-free sphygmomanometer and an automated oscillometric device were compared with mercury sphygmomanometry in 170 hypertensive and 170 normotensive pregnant women. The mercury-free sphygmomanometer appears to be the more accurate and an acceptable replacement for mercury in pregnancy.

  • A five year postpartum follow-up study of the physical and mental health of women, and the health and development of their babies, in women who had high blood pressure in pregnancy and those who did not.

    The purpose of this study is to compare the physical and mental health of mothers, and the health and development of their babies, in women who had high blood pressure in their pregnancy and women who had normal blood pressure. Specific aims are to: 1. establish normal ranges in our local population in the first five years after birth 2. Identify significant differences from normal in women who had high blood pressure 3. Identify women and/or infants who may be at increaed risk of physical, mental or developmental problems in the long term The primary hypothesis is that women who had high blood pressure in their pregnancy will have abnormal physical parameters eg higher blood pressure, more frequent depressive symptoms and their babies are more likely to have health and/or developmental problems at six months and two years of age.

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