Trials
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Surgical site infections are the third most frequent type of nosocomial infections. Evidence-based recommendations have been given regarding preoperative hospitalization, hygiene and air-conditioning, patient conditions, and wound dressing. However, no general recommendations concerning wound closure exist. Systematic reviews and meta-analyses suppose a benefit of intracutaneous suture compared to skin staples in orthopedic and obstetric surgery. Literature data for skin closure in elective abdominal surgery are still deficient. ⋯ The trial is expected to balance the shortcomings of the current evidence. It will help to define the gold standard for wound closure in elective abdominal surgery. Patients' safety and quality of life are assumed to be enhanced. Therapy costs are likely to be reduced and health care optimized.
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Randomized Controlled Trial
Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial.
Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. ⋯ Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers.
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Randomized Controlled Trial
A double-blind, placebo-controlled intervention trial of 3 and 10 mg sublingual melatonin for post-concussion syndrome in youths (PLAYGAME): study protocol for a randomized controlled trial.
By the age of sixteen, one in five children will sustain a mild traumatic brain injury also known as concussion. Our research found that one in seven school children with mild traumatic brain injury suffer post-concussion syndrome symptoms for three months or longer. Post-concussion syndrome is associated with significant disability in the child and his/her family and yet there are no evidence-based medical treatments available. Melatonin has several potential mechanisms of action that could be useful following mild traumatic brain injury, including neuroprotective effects. The aim of this study is to determine if treatment with melatonin improves post-concussion syndrome in youths following mild traumatic brain injury. Our hypothesis is that treatment of post-concussion syndrome following mild traumatic brain injury with 3 or 10 mg of sublingual melatonin for 28 days will result in a decrease in post-concussion syndrome symptoms compared with placebo. ⋯ Melatonin is a safe and well-tolerated agent that has many biological properties that may be useful following a traumatic brain injury. This study will determine whether it is a useful treatment for children with post-concussion syndrome. Recruitment commenced on 4 December 2014.
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Randomized Controlled Trial
Peer volunteers in an integrative pain management program for frail older adults with chronic pain: study protocol for a randomized controlled trial.
Chronic pain is common among the older population. A literature review on pain management program showed that exercise, yoga, massage therapy, Tai Chi, and music therapy could significantly reduce pain. In spite of the proven benefits of pain management programs, these intervention programs were effective only in the short term, and older adults would resume their old habits. It has been suggested that interventions comprising some type of social support have great potential to increase the participation of older adults. Therefore, we propose the inclusion of peer volunteers in an integrated pain management program to relieve pain among frail older adults. This study aims to explore the effectiveness of an integrated pain management program supplemented with peer volunteers in improving pain intensity, functional mobility, physical activity, loneliness levels, happiness levels, and the use of non-pharmacological pain-relieving methods among frail older adults with chronic pain. ⋯ In view of the high prevalence of chronic pain among older adults and its adverse impacts, it is important to provide older adults with tools to control their pain. We propose the use of peer volunteers to enhance the effects of an integrated pain management program. It is expected that pain can be reduced and improvements can be achieved among older adults in the areas of physical activity, functional mobility, loneliness levels, happiness levels, and the use of non-pharmacological pain relieving methods. Using these results, we will assess the need to conduct a larger study with a randomized controlled design.
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Randomized Controlled Trial
A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial.
Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland). ⋯ The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.