ANZCTR search results

Provision and use of a question prompt list by patients during a consultation increases question asking, reduces anxiety and improves recall. Previous work on question prompt sheets has found that when patients ask more questions, they gain a better understanding of the topic and satisfied with their treatment decisions. Medical staff also tend to be more satisfied with the consent process when patient’s display a better understanding of the discussion. A Question Prompt List has been developed for patients to facilitate patient participation in clinical trial consent discussions. This project aims to examine patient attitudes to clinical trials and to investigate the effects of promoting question asking when people with cancer are asked to consider entering a randomised clinical trial. The question prompt list will be evaluated by comparing results for the control and intervention groups on understanding of clinical trial information, satisfaction with the consent process and decision-making about trial participation and achievement of their information and involvement preference. It is expected that those patients receiving the question prompt list will have a higher mean knowledge score in the informed consent questionnaire, have enhanced achievement of their information and involvement preference and be more satisfied with the informed consent and the decision making process.

The aim of this study is to evaluate the feasibility of a randomised controlled trial comparing two types of pre-discharge occupational therapy consultations for older adults: home-based versus hospital-based consultations. In particular the study will test the feasability of trial procedures consent rates, and the acceptability of both forms of consultation. Individuals who are aged over 65 years and living in the community prior to admission will be asked to participate. Study participants (n=10) will be randomly assigned to receive either a hospital-based or a home-based pre-discharge occupational therapy assessment and education. The home-based consultations are more time-consuming and costly than hospital-based consultations, however it is unknown if patient outcomes differ. Participants will be tested before and during the study using standardised outcome measures by a qualified occupational therapist who is blind to group allocation.

Chest physiotherapy (CPT) is a standard component of multidisciplinary care of preterm infants receiving artificial ventilation for respiratory failure. Despite this, there is limited evidence concerning its effectiveness. This study aims to quantify the effects of the physiotherapy techniques of percussion and vibration on respiratory function in the preterm infant. Data from the electrical impedance tomography (EIT) and the multiple breath washout (MBW) will be downloaded directly onto a computer. The data analyst will be blinded as to the intervention.

Preterm infants are moved throughout different positions while nursed in the neonatal nursery. The aim of this study is to determine the effects of 3 commonly used positions on lung function in those infants requiring ventilatory support. The positions to be used include prone (lying on the stomach), supine (lying on the back), and ¼ turn from prone (lying on stomach with one side up). By looking at the ventilation distribution during positioning, this study will give clinicians an idea of how to optimise ventilation non-invasively using positioning. Factors we are investigating that are important in making this decision are optimal lung aeration and oxygenation. This trial will use recently developed scientific technology including lung scanning (EIT) and a new form of breath washout (MBW using sulphur hexafluoride) to give us a better understanding of the effectiveness of positioning. Data on EIT and MBW will be downloaded directly onto a computer and the data analyst will be blinded to the positions.

Nasal hyper reactivity is characterised by a reflex mediated increased sensitivity to inhaled unspecific irritants such as cold air, perfumes and smoke. Patients with obstructive sleep apnoea syndrome (OSAS) are treated with a “continuous positive air way pressure” (CPAP) device that relies upon a good nasal patency during sleep. The present study aims at evaluating a new non-invasive device, the Rhinolux, to identify patients with an increased risk of having nasal hyper reactivity during CPAP treatment. The Rhinolux is an oximetry device that measures changes in nasal blood flow by light absorption in haemoglobin. The majority of the patients in this study will not have tested CPAP before eventhough they have been given a description of the treatment procedure. To control for the bias that having prongs in the nose could effect the nasal blood flow, all subjects will initially wear the prongs for 10 minutes before the CPAP pressure is applied. In this sence the study could be considered to be single blind because only the examiner will be fully aware at what time the CPAP pressure is turned on.

Metabolic syndrome (MetS) is a condition characterised by over-weight, poor blood sugar control and high blood pressure. The aim of this study is to investigate the effect of weight training on muscle mass and strength, blood sugar and cholesterol levels, body composition, functional capacity (energy for daily living), some important measures of cardiovascular health, and quality of life in people who live with metabolic syndrome. To enhance the scientific validity of the study, we will also make the same measurements in healthy people (normal weight). The main predicted outcome is that strength training will improve muscle function (eg the muscle may dispose of sugar more efficiently), strength and the ability to carry out daily activities. All of this should reduce your risk from future cardiovascular disease or diabetes, and improve your health and sense of well-being. Volunteer will be separated into two groups. One group (called the training group) will perform a resistance-training program and the other group (the control group) will continue their normal daily activities. The control group is essential for the study in order to determine if changes - provided they occur- in the training group are due to the resistance training itself. The separation into groups will be done randomly after initial testing.

Borderline Personality Disorder (BPD) is a disabling syndrome which is generally associated with a history of severe childhood trauma and/or neglect. The disorder is characterized by intense, distressing and changeable emotions, impulsive self-destructive behaviour and troubled relationships. Around three quarters of the people with this diagnosis engage in deliberate self-harm (such as cutting or burning themselves) and around eight to ten percent suicide. Treatment of the condition is difficult because of stormy relationships with treating staff and staff anxiety about clients’ suicidality and self-harm. Spectrum is a statewide public sector specialist service, which was established to support the treatment of clients with BPD. Since its inception eight years ago, Spectrum has provided consultation and training to staff, and residential treatment for a small number of clients. Spectrum has been examining ways of offering treatment for a larger number of clients. A difficulty has been the need to do this within Spectrum’s current level of resourcing and that of the Area Mental Health services. Group treatment is, in general a particularly cost effective approach, and has the added benefit of providing an opportunity for clients to expand their social networks. Our aim is to develop a group treatment approach for BPD that can eventually be delivered by area clinicians with Spectrum support. Recently a brief outpatient group treatment was trialed in America and found to be very successful in treating the symptoms of BPD. The groups aimed to teach clients ways of managing their troubling emotions in crises so as to reduce impulsive self-destructiveness. The approach used in that study has many similarities to Spectrum’s residential treatment, and to a group outpatient treatment piloted by Spectrum in 2005. The very positive findings of the American study have lent support to our decision to continue testing a similar outpatient group treatment. The project has two phases. In phase one a 12 week series of groups teaching Crisis Skills will be trialed. For some clients this 12 week group treatment (with ongoing individual treatment) will be enough. For those who require more group treatment, additional skills training will be offered in phase two. Phase two will consist of three further series of groups (each lasting 10 weeks), teaching Interpersonal Skills, Emotion Skills and Mindfulness Skills. Clients who enter phase two treatment will thus be provided with the opportunity for approximately a year of group treatment in total (including phases 1 and 2 and short breaks between modules of treatment). Sixty clients will be recruited into phase 1, via referrals from staff from AMHS staff in Eastern Health, Northwest Mental Health and the Werribee-Mercy Networks. All clients will need to have a support person who can assist them in practicing the skills: e.g. an AMHS or Community Health Centre clinician, GP, or private psychiatrist. These clinicians will receive information and support to assist them in their role.Clients will be invited to attend an information session and a screening interview with one of the Spectrum clinicians and a diagnostic interview with a research assistant. Informed consent will be obtained at the screening interview. Half the clients will be randomly allocated to start phase 1 groups immediately, and the remainder to start after three months. When all clients have been offered the phase 1 groups, phase 2 groups will be offered to all clients. In order to evaluate the treatment, and better understand how it works, clients who consent, will be asked to complete questionnaires before the first group of each series, mid-way through each group series, after the last group of each series, and at three month follow up. Phase 1 treatment will be evaluated by comparing the changes in the first 30 clients treated with the 30 clients on the waiting list, and by comparing test results, for all clients before and after phase 1 treatment. Outcomes from the combined phase 1 and phase 2 groups will also be evaluated, and the process of change examined.

This study will test an expressive writing intervention with bowel cancer patients to determine whether participation in the intervention leads to improved physical functioning, lessened psychological distress and increased personal growth, compared to those who do not participate in the intervention. Expressive writing is the writing of deep thoughts and feelings connected to a person's cancer diagnosis and treatment experiences. Participants in the intervention group will write in a journal for 30 minutes, 4 times, over 3 weeks. Participants will fill out questionnaires before and after the intervention as well as 2 months later, to determine whether they experience positive change, and changes over time.

Obesity is a major health problem, which contributes to significant morbidity and mortality in Australia. Energy restriction and exercise are commonly advocated as lifestyle approaches for the modification of cardiovascular disease risk factors such as obesity, hyperlipidemia, impaired glucose tolerance, and insulin resistance. In response to the increasing concerns about the rising level of obesity, there has been a multitude of “fad” diets developed outside the medical and nutritional recommendations for healthy eating and with this an increased popularity of diets very low in carbohydrates. However, due to the scant scientific evidence available for the long-term efficacy and safety of these diets, and their impact on risk factors for cardiovascular disease, cancer, renal function, bone health, psychosocial function and the capacity to undertake concurrent physical activity, there is a lack of evidenced-based public health recommendations and policy regarding these dietary patterns. This study will provide scientific evidence to validate optimum dietary recommendations for weight loss that can be used by health professionals who have a strong need for a rational basis for their advice to counsel obese patients.

Research Aim The manufacturer’s current recommendation for the rate of administration of tramadol is over 2-3 minutes. In spite of this, many clinicians administer tramadol as a slow infusion as they believe that this reduces the incidence of some side effects including nausea and vomiting. The aim of this research is to determine whether there is a different incidence of nausea and vomiting when tramadol is administered slowly or rapidly. Study Outline Patients greater than or equal to 18 years of age presenting for significant non-abdominal surgery at the Royal Melbourne Hospital will be studied. These patients are at significant risk of post-operative pain and often require continuing post-operative analgesia. After informed consent, patients will undergo their respective surgical operations under a standardised general anaesthetic. All patients will receive intravenous morphine for intra-operative analgesia and morphine patient-controlled analgesia (PCA) for post-operative analgesia. Patients will be randomised to receive tramadol or placebo, immediately postoperatively, in the post-anaesthetic care unit (PACU) in one of the following ways: 1)Intravenous tramadol (2.5 mg/kg) fast (conventional therapy over 120 seconds as per manufacturer’s product information) 2)Intravenous tramadol (2.5 mg/kg) slowly (over 30 minutes) 3)Placebo (no tramadol) Postoperatively, when the patient is fully awake and able to speak, they will be asked to rate their pain on a 100mm visual analogue scale (0 = No pain to 100mm = Worst imaginable pain). Patients will only receive tramadol or placebo in one of the above ways if they rate their pain as greater than 30mm on a 100mm visual analogue scale. Otherwise they will be excluded from the trial. At this point in the PACU, they will receive their trial drug (tramadol or placebo) as planned. Patients will be reviewed at 0 (before administration of tramadol/ placebo), 0.25, 0.5, 1, 2 and 3 hours after the administration of tramadol or placebo is commenced. Recordings for nausea, using a visual analogue scale (0 = No nausea to 100mm = Worst imaginable nausea), and episodes of vomiting will be the main clinical outcomes measured. Additionally, PCA usage, pain scores and patient satisfaction will be recorded. 4. Study Endpoints Primary End Point: Comparative peak change from baseline in nausea visual analogue score (VAS) scores between fast, slow and placebo tramadol administration groups. Secondary End Points: Comparative vomiting frequencies, morphine PCA usage, pain scores, duration spent in PACU and patient satisfaction scores between fast, slow and placebo tramadol administration groups. Research Plan This trial will be conducted in the operating theatres and surgical wards of the Royal Melbourne Hospital. Ethics committee approval will be obtained prior to the commencement of the trial. Patients presenting for the trial who meet the eligibility criteria will be approached and written informed consent will be obtained. This will occur in the pre-admission clinic or day of surgery admission area of the Royal Melbourne Hospital. Eligibility Inclusion Criteria • Males and females aged 18-50 years • English spoken as first language, or fluent as a second language • Scheduled to have elective non-abdominal surgery under general anaesthesia (including general, orthopaedic, plastic, ENT, urologic, dental or vascular surgery) • Requiring general anaesthesia • Significant post-operative pain requiring opioid therapy expected Exclusion Criteria • Inadequate English comprehension • History of allergy or sensitivity to tramadol or morphine • History of previous episode of significant post operative nausea and vomiting • History of significant motion sickness • Epilepsy • Administration of tramadol within previous 36 hours • American Society of Anaesthesiologists’ (ASA) physical status IV or V, reflecting serious cardiorespiratory co-morbidity. • Currently taking selective serotonin receptor inhibitor, tricyclic antidepressant or monoamine oxidase inhibitor drugs • Currently taking prophylactic antiemetics • Pregnancy Randomisation and Blinding A three-arm prospective randomised double-blind controlled trial will be undertaken. All eligible patients will be randomised preoperatively to one of three groups by using sealed opaque envelopes containing the information regarding whether the patient is to receive tramadol ‘fast’ or ‘slow’ or receive placebo. Envelopes will not be opened until after consent is obtained. Randomisation will be performed using a computer-generated list. All patients will be blinded to which group they are in and all will receive a loading dose of 2.5 mg/kg of tramadol (or placebo) intravenously as this has been shown to be the optimum amount required for maximal efficacy with minimal side effects. The study drugs will be prepared by a research nurse/ pain nurse and labelled ‘Fast’ or ‘Slow’. One or both of theses study drugs will be placebo but the identity will be unknown to the patient, PACU nurse looking after that patient and investigator (Dr Sud Agarwal, Dr Malcolm Hogg or AMS Medical Student) who will be collecting data from that patient. The PACU nurse will administer the drugs blind to the identity of the drugs. The identity of the ‘Fast’ and ‘Slow’ study drugs will be recorded by the research nurse/ pain nurse and will not be made available to the investigators. ‘Fast’ group – will receive 2.5 mg/kg tramadol (made to 10 ml with addition of saline) intravenously over 2 minutes and 10 ml saline via a syringe driver over 30 minutes. ‘Slow’ group – will receive 10 ml saline over 2 minutes and 2.5 mg/kg tramadol (made to 10 ml with addition of saline) intravenously via a syringe driver over 30 minutes. ‘Placebo’ group – will receive 10 ml saline over 2 minutes and 10 ml saline via syringe driver over 30 minutes. Postoperative assessment regarding nausea, pain, vomiting frequency, patient satisfaction and morphine PCA usage will be performed by a second blinded second investigator. Sample Size Calculation The sample size of 150 patients is calculated based on reported peak nausea visual analogue scores in response to 2.5 mg/kg of intravenous tramadol: ? = 0.05 ? = 0.2 ? = 0.3 (a 3 out of 10 difference on a ten point Visual Analogue Score) ? = 0.5 (Standard Deviation)15 Calculates sample size required in each group as 44 for p<0.05. Sample sizes of 50 for each group have been chosen to allow for patients dropping out or being excluded after recruitment. This sample size was calculated using the UCLA statistical sample size calculator. Nausea Score Estimation Nausea after the administration of tramadol will be obtained at described time intervals (t = 0, 0.25, 0.5, 1, 2 and 3 hours) using a 100-mm visual analogue scale. All participants will be asked to make a mark on a continuous scale to indicate the level of nausea experienced. Procedure Operative Period All patients will be given a standardised general anaesthetic for their surgical procedure with patient and equipment monitoring implemented as per the Australian and New Zealand College of Anaesthetists’ guidelines. A standard and widely practiced anaesthetic technique will be utilised. This will include midazolam, fentanyl, propofol (and atracurium for relaxant general anaesthesia) for induction followed by maintenance with sevoflurane in 50% oxygen in nitrogen. All patients who had relaxant general anaesthesia will receive neostigmine and glycopyrrolate reversal. Inhaled anaesthetic concentration will be at the discretion of the attending anaesthetist. Morphine, paracetamol or NSAIDs may be utilised for intraoperative analgesia. Wound infiltration with local anaesthetics by surgeons at any time of the procedure is permissible, but the use of tramadol or any antiemetics are not permitted intraoperatively or postoperatively unless it is being administered as part of this trial or as rescue anti-emesis. Post-operative Period In the PACU immediately following the end of their operation, all patients will receive tramadol or placebo as per the directions for the group they have been randomised to (see above under Randomisation and Blinding). Patients in all groups will be asked to describe their nausea, pain, dizziness and patient satisfaction score on four separate 100-mm visual analogue scales (VAS) at 0, 0.25, 0.5, 1, 2 and 3 hours after commencement of administration of tramadol. In addition, PCA usage and any episodes of vomiting will be recorded for all patients within the three hour period. ‘Rescue Analgesia’ Any patient who continues to have inadequate analgesia even after receiving paracetamol, NSAIDs and morphine via PCA will be reviewed by the pain registrar on call at that time and will be given morphine intravenous boluses until their pain is relieved. ‘Rescue Anti-emesis' Any patient who continues to experience significant nausea (greater than 70 mm on VAS) or who vomits will be reviewed by the pain registrar on call at that time and will be offered antiemetics: 10-20 mg metoclopramide and/ or 0.02 mg/kg droperidol and/ or 4-8 mg dexamethasone and/or ondansetron 4-8 mg until their nausea/ vomiting is relieved. Data Collection Pre-operative: age, sex, height, weight, ASA physical status, operation, smoking status, menstrual status (if applicable), history of motion sickness, history of PONV. These (along with duration of anaesthesia) include all the factors cited by Apfel as prospective predictors which allow PONV risk scoring16. Intra-operative: IV morphine total dose, fentanyl/ paracetamol/ NSAID/ alpha-2 agonist usage, estimated average sevoflurane expired end-tidal concentration, estimated average inspired oxygen concentration, use of local anaesthetic wound infiltration, any surgical complications, total surgical time, duration of anaesthesia. Post-operatively: (in theatre PACU and hospital wards): analgesic requirements (IV and oral opioids, paracetamol, NSAIDS), pain scores, requirement for any ‘rescue analgesia’, nausea VAS, pain VAS, dizziness VAS, patient satisfaction VAS, total morphine PCA usage, requirement for any ‘rescue anti-emesis’, number of episodes (if any) of vomiting and duration of stay in PACU. Nausea, pain, dizziness and satisfaction data will be collected by a second blinded investigator who will ask all patients to mark a standard 100 mm VAS. Any clinically significant event during the course of the study period (3 h) (such as seizures, rash etc) will be recorded. A Log will be kept including the number of eligible patients, refusals, recruited and randomised patients, dropouts and completed participants.