Trials
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Multicenter Study Observational Study
The implausibility of 'usual care' in an open system: sedation and weaning practices in Paediatric Intensive Care Units (PICUs) in the United Kingdom (UK).
The power of the randomised controlled trial depends upon its capacity to operate in a closed system whereby the intervention is the only causal force acting upon the experimental group and absent in the control group, permitting a valid assessment of intervention efficacy. Conversely, clinical arenas are open systems where factors relating to context, resources, interpretation and actions of individuals will affect implementation and effectiveness of interventions. Consequently, the comparator (usual care) can be difficult to define and variable in multi-centre trials. Hence outcomes cannot be understood without considering usual care and factors that may affect implementation and impact on the intervention. ⋯ We examined and identified contextual and organisational factors that may impact on the implementation of our intervention. We found usual practice relating to sedation, analgesia and ventilator weaning broadly similar, yet distinctively different from our proposed intervention, providing assurance in our ability to evaluate intervention effects. The data will enable us to develop an implementation plan; considering these factors we can more fully understand their impact on study outcomes.
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Randomized Controlled Trial Clinical Trial
Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial.
The pain of a severe burn injury is often characterised by intense background pain, coupled with severe exacerbations associated with essential procedures such as dressing changes. The experience of pain is affected by patients' psychological state and can be enhanced by the anxiety, fear and distress caused by environmental and visual inputs. Virtual Reality (VR) distraction has been used with success in areas such as burns, paediatrics and oncology. The underlying principle of VR is that attention is diverted from the painful stimulus by the use of engaging, dynamic 3D visual content and associated auditory stimuli. Functional magnetic resonance imaging (fMRI) studies undertaken during VR distraction from experimental pain have demonstrated enhancement of the descending cortical pain-control system. ⋯ The study accrual rate is currently slower than predicted by previous audits of admission data. A review of the screening log has found that recruitment has been limited by the nature of burn care, the ability of burn inpatients to provide informed consent and the ability of patients to use the VR equipment. Prior to the introduction of novel interactive technologies for patient use, the characteristics and capabilities of the target population needs to be evaluated, to ensure that the interface devices and simulations are usable.
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Randomized Controlled Trial
Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial.
Osteoarthritis of the knee is a major cause of disability among adults. Electro-acupuncture is considered a potentially useful treatment for osteoarthritis. The purpose of this study is to assess the efficacy of electro-acupuncture on pain control, pain perception, plasma cortisol and beta-endorphin levels, patient-perceived quality of life, and pain medication use in patients with chronic knee pain. ⋯ The findings from this study will help to determine whether electro-acupuncture is effective for chronic knee pain management in older people and whether electro-acupuncture can deliver results for the improvement of pain relief, stiffness, and disability. The study will therefore be a major step toward understanding the roles of the hypothalamic-pituitary-adrenal axis and the endogenous opioid system in the effectiveness of electro-acupuncture for chronic pain.
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Randomized Controlled Trial
Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial.
Surgical site infections (SSIs) are the second most common form of nosocomial infection. Colorectal resections have high rates of SSIs secondary to the inherently contaminated intraluminal environment. Negative pressure wound therapy dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. No randomized control trials exist to support the use of negative pressure wound therapy following elective open colorectal resection to reduce surgical site infection. ⋯ NEPTUNE is the first randomized controlled trial to investigate the role of incisional negative pressure wound therapy in decreasing the rates of surgical site infections in the abdominal incisions of patients following an elective, open colorectal resection. This low-risk intervention may help decrease the morbidity and costs associated with the development of an SSI in our patients.
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Randomized Controlled Trial
A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.
Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). ⋯ Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis.