Daily interruption of sedative infusions in an adult medical–surgical intensive care unit: randomized controlled trial

Title. Daily interruption of sedative infusions in an adult medical–surgical intensive care unit: randomized controlled trial. Aim. This article is a report of a study conducted to determine if a nursing‐implemented protocol of daily interruption of sedative infusions vs. sedation as directed by the intensive care unit team would decrease duration of mechanical ventilation. Background. Continuous rather than intermittent infusion of sedative and analgesic agents leads to greater stability in sedation level, but has been correlated with prolongation of mechanical ventilation and hospitalization of critical care patients. Daily interruption of sedative infusions in mechanically ventilated patients has reduced the duration of mechanical ventilation and length of stay in intensive care. Method. A randomized controlled trial was carried out from November 2004 to March 2006 with 97 patients receiving mechanical ventilation and continuous infusion of sedative drugs in an intensive care unit in Greece. The primary outcome measure was the duration of mechanical ventilation. Secondary outcomes were length of intensive care unit stay, length of hospital stay, overall mortality, total doses of sedative and analgesic medicines and Ramsay scores and duration of cessation of sedative infusions per day. Results. The median duration of mechanical ventilation was 8·7 days vs. 7·7 days (P = 0·7). Length of intensive care unit stay (median: 14 vs. 12, P = 0·5) and in the hospital (median: 31 vs. 21, P = 0·1) was similar between the intervention and control groups. The absence of statistically significant differences in these variables remained when patients with brain injury were examined separately. Conclusion. The nursing‐implemented protocol of daily interruption of sedative infusions was neither beneficial nor harmful compared with usual practice, which has as its primary target the earliest possible awakening of patients.     

Effects of combination oral care on oral health,dry mouth and salivary pH of intubated patients: A randomized controlled trial

Intubated patients are at risk of oral health problems. Although a variety of oral care regimens for intubated patients have been studied, there is a lack of research on the effects of combination oral care that includes tooth brushing, chlorhexidine and cold water. This open‐labelled, randomized, controlled trial aimed to evaluate the effects of combination oral care on oral health status. Participants aged 20 years and older were recruited on the first day after intubation through convenience sampling in a medical intensive care unit. Random assignment was performed using an internet randomization service. The primary outcome was oral health status. Data were collected during May and June 2013. Participants were randomized to one of two groups (23 intervention and 21 control). The final analysis included 18 patients with combination oral care and 17 in the control group. The intervention group had better oral health (effect size = 1.56), less dry mouth and higher salivary pH than the control group. Any additional burden of providing combination oral care to patients who are mechanically ventilated is worthwhile in terms of clinical outcomes.     

Efficacy of a self-management education program for people with type 2 diabetes: Results of a 12 month trial

Aim:  Patient education that enhances one's self-management ability is of utmost importance for improving patient outcomes in chronic diseases. We developed a 12 month self-management education program for type 2 diabetes, based on a previous 6 month program, and examined its efficacy.
Methods:  A randomized controlled trial was carried out on outpatients with type 2 diabetes from two hospitals who met the criteria and gave consent to participate. They were randomly divided into an intervention group that followed the program and a control group that followed usual clinical practise. The intervention group received <30 min of monthly interviews based on the program's textbook and biweekly telephone calls from a nurse educator throughout the 12 months.
Results:  Of the 50 participants in the intervention group and the 25 participants in the control group, 42 and 23, respectively, completed the program (a completion rate of 84.0%). The body weight, HbA1c, self-efficacy, dietary and exercise stages, quality of life, diastolic blood pressure, and total cholesterol level were significant by two-way repeated-measures anova . As for changes over time within the groups, only the intervention group showed significant differences by Friedman's test. The complication prevention behaviors showed a high implementation rate in the intervention group. The overall evaluation of this program by the participants was very high and, therefore, they highly recognized the need for this type of program.
Conclusions:  Self-management education works successfully in relation to patients' behavior modification skills, degree of goal attainment, and self-efficacy, consequently improving their health outcomes.     

A multicomponent integrative intervention to slow down the progression of mild cognitive impairment: A protocol for a randomized controlled trial

Mild cognitive impairment affects 36% of people aged 65 years and over in China, and around 50% transition from mild cognitive impairment to dementia within 3 years. Early intervention can slow down disease progression and thus delay dementia onset. The purpose of this article is to outline the protocol of an ongoing randomized controlled trial in mainland China that will evaluate the effects and feasibility of a 6-month multicomponent integrative intervention on the speed of progression of mild cognitive impairment to dementia. Ninety-six community-dwelling older adults, aged 65 years and older, will be recruited (recruitment will be completed in May 2020), using strict inclusion/exclusion criteria, from two community health service centers in Guangzhou, Guangdong province. Participants will be allocated to receive either the multicomponent integrative intervention or usual care. The core components of the intervention are cognitive training, dietary instruction, physical activity, and management of vascular risk factors. Data are collected at the beginning of the study, then at 1, 3, and 6 months. The primary outcome is cognitive function. The main secondary outcomes are exercise capacity, comprehensive physical capacity, depression, and quality of life. An intention-to-treat analysis will be conducted. The study will be completed in 2021. The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.     

Clonidine in the sedation of mechanically ventilated children: A pilot randomized trial

Purpose

Clonidine is often used as a sedative in critically ill children, but its effectiveness has not been evaluated in a large, rigorous randomized controlled trial. Our objectives in this pilot trial were to assess the feasibility of a larger trial with respect to (1) effective screening, (2) recruitment, (3) timely drug administration, and (4) protocol adherence.

Materials and methods

This is a randomized, blinded, placebo-controlled pilot trial. Mechanically ventilated children received enteral clonidine 5 μg/kg or placebo every 6 hours; additional sedatives were at the discretion of attending physicians.

Results

We enrolled 50 children. The median interquartile range (IQR) age was 2.5 (0.7-5.2) years, and Pediatric Risk of Mortality score on pediatric intensive care unit admission was 12 (8-15). In terms of feasibility outcomes, 90 (87%) of 104 eligible patients were approached for consent, and on average, 1.7 children were enrolled per month. Thirty-five (70%) were enrolled within 1 day of becoming eligible (mean, 1.2 days). Thereafter, 94% of doses were administered by protocol. Clinical outcomes and adverse effects were not significantly different between the groups.

Conclusions

This pilot trial demonstrated feasibility of a larger randomized controlled trial. Some important challenges emerged, allowing refinement of the study protocol and enrolment estimates. We recommend that future trials capitalize on the experience gained and use these results to design a larger trial focusing on clinically important outcomes.     

Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol

porter s., holmes v., mclaughlin k., lynn f., cardwell c., braiden h.-j., doran j. & rogan s. (2012)?Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol. Journal of Advanced Nursing68(10), 2349-2358. ABSTRACT: Aims. This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Background. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Study design. Music in mind is a multi-centred single-blind randomized controlled trial involving 200 young people (aged 8-16?years) and their parents. Eligible participants will have a working diagnosis within the ambit of International Classification of Disease 10 Mental and Behavioural Disorders and will be recruited over 15?months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collected from young people and their parents using standardized outcome measures for communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13?weeks after the final music therapy session. A cost-effectiveness analysis will also be carried out. Discussion. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204. Ethical approval was gained in October 2010.