ANZCTR search results

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

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32851 results sorted by trial registration date.
  • Effect of the first laparoscopy in an adolescent and young adult female population and its association with chronic pelvic pain

    This is a randomised controlled pilot study to examine the effect of key-hole surgery on pelvic pain in women aged 16-25 years old who present with pain with no obvious cause to the gynaecology service at the Royal Hospital for Women. Women will be randomised into either non-surgical (oral medications) or surgical (laparoscopic) management. Laparoscopy is generally performed to investigate and treat endometriosis although it is common for there to be no findings on laparoscopy, and if endometriosis is found, pain can persist despite surgery. Therefore the optimum management for pelvic pain in adolescent and young women is unknown. The objective of this study is to demonstrate the effect of laparoscopy on pre operative; immediate and long-term post-operative pelvic pain and quality of life using standardised questionnaires. Patients will be followed-up at 6 weeks, 6 months, 12 months and 24 months after initiation of treatment.

  • Randomised Controlled Trial to reduce unhealthy snacking: evaluation of planning tools and method of allocation in a sample with diverse health literacy and diabetes or high BMI

    Health literacy interventions typically address health literacy by presenting information in a simpler format. Whilst there is strong evidence that this supports comprehension of health information, the evidence is less clear for self-management behaviours. This is consistent with reviews reporting that key strategies to promote action (e.g. action plans) are often underutilised in health literacy interventions. Existing strategies to promote action are often unsuitable for people with lower health literacy because they are cognitively demanding. Our recent study addressed this issue by evaluating a ‘health-literate’ action plan. This included simple language and images, and guided users to generate effective plans. After four weeks, participants with lower health literacy who used the health-literate action plan significantly reduced their reported intake of unhealthy snacks compared to those using a ‘standard’ action plan. The reverse was true for participants with higher health literacy, indicating that the health-literate action plan must target the appropriate audience to be optimally effective. This tool was effective in a general population for a behaviour that is key to diabetes self-management. The current study will test a similar intervention to improve self-management for people with diabetes and/or overweight/obese BMI. The current study will also explore two practical options for targeting people with low health literacy: a validated screening question for low health literacy; and allowing people to freely choose between the two action plans. The latter has the added advantage of increasing intervention satisfaction, which is likely to increase engagement. AIMS AND HYPOTHESES AIM 1. To replicate the findings of the previous study in a clinical sample of Australians with type 2 diabetes, and identify the most effective action plan formats for this population. AIM 2. To investigate the optimal method to allocate people to the action plan that is most appropriate for their health literacy level, to inform implementation via two diabetes apps. AIM 3: to evaluate whether assessment of participant preference for an intervention prior to random allocation influences the effectiveness of the intervention. Hypotheses: 1. The health-literate action plan will be more effective at reducing unhealthy snacking for people with lower health literacy, whereas the standard action plan will be more effective for higher health literacy. 2. The intervention will be more effective at reducing unhealthy snacking for people who are allocated an action plan using the health literacy screening tool compared to those who are asked to select their preferred plan. Both of these allocation methods will be more effective than random allocation to an action plan. 3. Assessing preference will negatively impact plan effectiveness, an effect which will be greater for those who are randomised to the plan which is discordant with their preference.

  • Reel2Real: Evaluation of an online social media literacy program to decrease body dissatisfaction in young adults

    Social media use by young Australians is very common. Despite many positive benefits of social media interaction, its use can also lead to negative outcomes including body dissatisfaction, eating problems, and depressed mood. Social media literacy is a new approach to help prevent these negative effects This approach involves thinking critically about social media content and recognising the purpose behind posts as well as thinking about whether or not social media posts reflect real life or only a slice of the “best” bits, or a highlight reel. The project aims to examine effects for body dissatisfaction, eating problems, and mood for young men and women who take part in the social media literacy program, REEL2REAL, compared with people who receive the program after a short delay. We expect that people will experience a benefit from participation for their body dissatisfaction, eating problems, and mood.

  • Evaluation of Continuous Positive Airway Pressure Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories for product development

    Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) therapy acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. CPAP compliance is strongly influenced by the patient’s mask system. As masks are worn every night the comfort, seal, stability and ease of use of a CPAP mask is highly important. The product development of mask systems is an iterative process. Evaluation of the comfort, seal, stability and ease of use of the mask system by patients in their home environment provides the required information for these iterative design changes. This project will allow the iterative testing of mask systems by patients by comparing them to already released masks or acceptable subjective levels.

  • Assessing the diagnostic performance of faecal occult blood testing, against colonoscopy, in people at elevated risk for bowel cancer.

    This study aims to evaluate the effectiveness of the 'Faecal Immunochemical Test' (FIT) as a diagnostic tool in patients considered at elevated risk for colorectal cancer and who have an upcoming surveillance colonoscopy. Who is it for? You may be eligible to join this study if you are male or female, aged 18 years or older, are enrolled in the SCOOP Program and have a scheduled surveillance colonoscopy. Study details All patients enrolled in the SCOOP program, with a pending surveillance colonoscopy will be invited to complete and return a FIT kit, two weeks prior to their colonoscopy so the results from the FIT and the colonoscopy, can be compared to each other to validate the FIT as an effective surveillance tool. The purpose of this study is to understand the accuracy of FIT relative to colonoscopy with regard to detecting both colorectal cancer and polyps that are pre-cancerous. While much is known about the effectiveness of FIT as a general screening tool, we would like to gather data on its effectiveness when compared to colonoscopy, in a population of people who are under surveillance with colonoscopy. Our research may lead to increased confidence and validation in the use of FIT as an effective surveillance tool for patients with an elevated risk for colorectal cancer and reduce the need for unnecessary colonoscopies for patients within the SCOOP Program.

  • Wellbeing warriors: Examining the effects of martial art training on mental health outcomes for secondary school students

    The research aims to examine the relationship between mental health and martial arts, specifically considering the mental health and behavioural effects resulting from participation in a 10-week martial arts based therapeutic intervention, delivered to participants (age range 11 to 14 years) in high schools using a randomised controlled trial research methodology. As previous research of this topic is limited and ambiguous, the study is expected to demonstrate to what extent martial arts are an efficacious alternative therapy that reduces mental illness, such as mood and behavioural issues; and promotes characteristics associated with mental health and wellbeing, such as self-efficacy and resilience.

  • Behavioral habits of contact lens wearers

    Inappropriate water exposure can add to microbial contamination of the CL, storage case and cause sight threatening adverse events such as Acanthamoeba keratitis. In this study we propose to investigate the impact of CL packaging displaying a ‘no water’ logo graphic and evaluate whether this affects CL wearers’ behaviours and attitudes to CL care/ wear and the microbial contamination of the CL storage case. We hypothesize that inclusion of "no water"logo graphic will change CL wearer's behavior towards less water exposure during CL use and ultimately will lower the microbial contamination of CL storage case.

  • Fatigue and perceived comfort of occupational footwear

    The purpose of the current study is to compare three currently-available work boots for comfort as well as their effects on fatigue, musculoskeletal pain and both physical and cognitive performances.

  • Achieving a good night's sleep using a non-pharmacological approach: a pilot trial in people with dementia and their families

    The aim of this study is to test the feasibility of conducting a trial to examine the efficacy of a non-pharmacological intervention, which includes tailored intervention and exposure to light in people with dementia with sleep disturbance living in the community.

  • Effectiveness of Activated B-vitamins compared with Standard B-vitamins in easing stress and fatigue in students.

    Vitamin supplement use is prevalent in Australia. B-vitamin supplements have been shown to reduce symptoms associated with stress and anxiety, and new 'activated' B vitamins are claimed to achieve this clinical outcome with greater efficiency. However, despite the increased costs, there are no clinical data to support this health claim. Tertiary students are at high risk of increased stress. This randomised control trial will compare the effectiveness of activated B-complex vitamins against standard-B-complex vitamins on stress, fatigue and anxiety outcomes in tertiary students. Participants will be recruited from the Sydney campus of Endeavour College of Natural Health and randomly assigned to one of two groups; 1.Activated-B or 2.Standard-B. The study duration will be four weeks, including a pre-treatment week and baseline data collection and treatment for three weeks. The primary outcome measure will be the validated instrument DASS 21; secondary outcomes will include the Fatigue Severity Scale and feasbility markers; recruitment, retention and adherence of participants.

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