Trials
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Randomized Controlled Trial
Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra-peritoneal Vacuum Trial): study protocol for a randomized controlled trial.
Damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy System, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker's vacuum pack. ⋯ Results from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker's vacuum pack.
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Randomized Controlled Trial
Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial.
Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effects of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a smartphone application. The effect of added therapist support will also be studied. ⋯ To our knowledge, this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders. Hence, the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions. Limitations are discussed.
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Randomized Controlled Trial
Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial).
In line with the growing number of surgical procedures being performed worldwide, postoperative complications are also increasing proportionately. Prevention of these postoperative complications is a high medical priority. Preoperative education of patients, including provision of preparatory information about the correct behavior after surgery, could improve the postoperative outcome, but the evidence for this is inconclusive. The aim of the PEDUCAT trial is to evaluate the feasibility and the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgery. ⋯ PEDUCAT is designed as a cluster-randomized controlled pilot study. The experimental group will visit a standardized preoperative seminar to learn how best to behave after surgery in addition to being given a standard information brochure, whereas the control group will only receive the information brochure. Outcome measures such as postoperative morbidity, postoperative pain, postoperative anxiety and depression, patient satisfaction, quality of life, length of hospital stay and postoperative mortality will be evaluated. Statistical analysis will be based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison, adjusting for age, center and quality of life before surgery. This is a pilot study to show the feasibility of the concept. Nevertheless, the planned sample size of n = 204 is large enough to show an effect with power of 90% and a significance level of 5%.
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Randomized Controlled Trial
Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans' Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial.
Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans' Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, this article describes the design of a randomized controlled trial to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. ⋯ This study is the first randomized controlled trial to evaluate the effectiveness of off-the-shelf footwear in reducing foot pain in DVA recipients. The intervention has been pragmatically designed to ensure that the study findings can be implemented into policy and clinical practice if found to be effective.
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Randomized Controlled Trial
'TXT2BFiT' a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: study protocol for a randomized controlled trial.
Despite international efforts to arrest increasing rates of overweight and obesity, many population strategies have neglected young adults as a target group. Young adults are at high risk for unhealthy weight gain which tends to persist throughout adulthood with associated chronic disease health risks. ⋯ This mobile phone based program addresses an important gap in obesity prevention efforts to date. The method of intervention delivery is via platforms that are highly accessible and appropriate for this population group. If effective, further translational research will be required to assess how this program might operate in the broader community.