scholarly journals Analgesic Effect of Auricular Point Acupressure for Acute Pain in Patients with Dementia: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Xiao-Min Chai ◽  
Hong-Yan Shi ◽  
Jun-Jun Zhang ◽  
Lei Wang ◽  
Hai-Xaing Gao ◽  
...  
Keyword(s):  
Nursing Homes ◽  
Acute Pain ◽  
Analgesic Effect ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled ◽  
Auricular Point ◽  
Dementia Patients ◽  
People With Dementia

Abstract Background: Common and frequent as acute pain is, it is often underestimated and undertreated in older people with dementia in nursing homes and inadequate pain management remains an issue. Methods: The study is designed to be a randomized, sham-controlled trial and is underway in nursing homes located in China. A total of 206 dementia patients are being recruited from nursing homes in Yinchuan, China. They are randomly allocated to an intervention or a controlled group in a 1:1 ratio. The intervention group will be treated with true APP therapy, while the other group will receive APP at sham points stimulation therapy. The patients will be assessed at baseline (T0), at 5 min during performing the intervention (T1) and at 5 min after completion of the intervention (T2). The primary outcome is the level pain relief at T1, and T2. Physiological parameters, side effects and additional use of analgesics during the procedure, satisfaction from caregivers, acceptance of patients are evaluated as secondary outcomes. Discussion: The results of this study are expected to verify the analgesic effect of APP for acute pain in patients with mild dementia in nursing homes. It has the potential to prompt APP therapy to be implemented widely in dementia patients with acute pain in nursing homes. Trial registration: ChiCTR2100047932. http://www.chictr.org.cn/edit.aspx?pid= 128647&htm=4. Registered on June 27, 2021. Currently, patients recruitment is ongoing. Recruitment is expected to take place from December 2020 to December 2021.

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial

2014 ◽  
Vol 40 (6) ◽  
pp. 598-606 ◽  
Author(s):  
B. Rosén ◽  
P. Vikström ◽  
S. Turner ◽  
D. A. McGrouther ◽  
R. W. Selles ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nerve Repair ◽  
Intervention Group ◽  
Control Group ◽  
Level Of Evidence ◽  
Test Part ◽  
Randomized Controlled ◽  
Identification Test

We assessed the use of guided plasticity training to improve the outcome in the first 6 months after nerve repair. In a multicentre randomized controlled trial, 37 adults with median or ulnar nerve repair at the distal forearm were randomized to intervention, starting the first week after surgery with sensory and motor re-learning using mirror visual feedback and observation of touch, or to a control group with re-learning starting when reinnervation could be detected. The primary outcome at 3 and 6 months post-operatively was discriminative touch (shape texture identification test, part of the Rosen score). At 6 months, discriminative touch was significantly better in the early intervention group. Improvement of discriminative touch between 3 and 6 months was also significantly greater in that group. There were no significant differences in motor function, pain or in the total score. We conclude that early re-learning using guided plasticity may have a potential to improve the outcomes after nerve repair. Level of evidence: II

scholarly journals The Effects of Exercise on Falls in Older People With Dementia Living in Nursing Homes: A Randomized Controlled Trial

2019 ◽  
Vol 20 (7) ◽  
pp. 835-842.e1 ◽  
Author(s):  
Annika Toots ◽  
Robert Wiklund ◽  
Håkan Littbrand ◽  
Ellinor Nordin ◽  
Peter Nordström ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Homes ◽  
Older People ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
People With Dementia

scholarly journals Photo-Integrated Conversation Moderated by Robots for Cognitive Health in Older Adults: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Mihoko Otake-Matsuura ◽  
Seiki Tokunaga ◽  
Kumi Watanabe ◽  
Masato S. Abe ◽  
Takuya Sekiguchi ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Outcome Measures ◽  
Cognitive Functions ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Social Activity ◽  
Intervention Group ◽  
Randomized Controlled

AbstractBackground and ObjectivesSocial interaction might prevent or delay dementia, but little is known about the specific effects of various social activity interventions on cognition. This study conducted a single-site randomized controlled trial (RCT) of Photo-Integrated Conversation moderated by a Robot (PICMOR), a group conversation intervention program for resilience against cognitive decline and dementia.Research Design and MethodsIn the RCT, PICMOR was compared to an unstructured group conversation condition. Sixty-five community-living older adults participated in this study. The intervention was provided once a week for 12 weeks. Primary outcome measures were the cognitive functions; process outcome measures included the linguistic characteristics of speech to estimate interaction quality. Baseline and post-intervention data were collected. PICMOR contains two key features: (i) photos taken by the participants are displayed and discussed sequentially; and (ii) a robotic moderator manages turn-taking to make sure that participants are allocated the same amount of time.ResultsAmong the primary outcome measures (i.e., cognitive functions), verbal fluency significantly improved in the intervention group. Among the process outcome measures (i.e., linguistic characteristics of speech), the amount of speech and richness of words were larger for the intervention group.Discussion and ImplicationsThis study demonstrated for the first time the positive effects of a robotic social activity intervention on cognitive function in healthy older adults via RCT. The group conversation generated by PICMOR may improve participants’ cognitive function controlling the amount of speech produced to make it equal. PICMOR is available and accessible to community-living older adults.

scholarly journals The effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eirin Kolberg ◽  
Gunnhild Johnsen Hjetland ◽  
Eirunn Thun ◽  
Ståle Pallesen ◽  
Inger Hilde Nordhus ◽  
...  
Keyword(s):  
Nursing Home ◽  
Controlled Trial ◽  
Intervention Group ◽  
Bright Light ◽  
Light Treatment ◽  
Control Group ◽  
Randomized Controlled ◽  
People With Dementia ◽  
Affective Symptoms ◽  
Cluster Randomized

Abstract Background The majority of people with dementia have behavioral and psychological symptoms of dementia (BPSD), including depression, anxiety and agitation. These may be elicited or aggravated by disrupted circadian rhythms. Bright light treatment (BLT) is a promising non-pharmacological approach to the management of BPSD, but previous research has yielded mixed results. Methods Eight nursing home dementia units (1 unit = 1 cluster) with 78 patients were invited to participate in a cluster randomized controlled trial from September 2017 to April 2018 investigating the effects of BLT on sleep and circadian rhythms (primary outcome) and BPSD (secondary outcome). Ceiling mounted LED-panels were installed in the intervention group (four units), providing light at 1000 lx and 6000 K (vertically at 1.2 m) between 10 a.m. and 3 p.m., with lower values in the mornings and evenings. Standard indoor light was used in the control group (four units). BPSD were assessed with The Cornell Scale for Depression in Dementia (CSDD) and the Neuropsychiatric Inventory Nursing Home Version (NPI-NH). Data collection took place at baseline and after 8, 16 and 24 weeks. Multilevel regression models with and without false discovery rate correction were used for the analysis, with baseline values and dementia stage entered as covariates. Results Sixty-nine patients were included in the study at baseline. Compared to the control group, the intervention group had a larger reduction on the composite scores of both the CSDD (95% CI = − 6.0 – − 0.3) and the NPI-NH (95% CI = − 2.2 – − 0.1), as well as on the NPI-NH Affect sub-syndrome, and the CSDD Mood related signs sub-scale at follow-up after 16 weeks. With FDR correction, the group difference was significant on the CSDD Mood related signs sub-scale (95% CI = − 2.7 – − 0.8) and the NPI-NH Affect sub-syndrome (95% CI = − 1.6 – − 0.2). No differences were found between conditions at weeks 8 or 24. Conclusion Compared to the control condition, affective symptoms were reduced after 16 weeks in the group receiving BLT, suggesting BLT may be beneficial for nursing home patients with dementia. Trial registration ClinicalTrials.gov Identifier: NCT03357328. Retrospectively registered on November 29, 2017.

Effects on sleep from group activity with a robotic seal for nursing home residents with dementia: a cluster randomized controlled trial

2020 ◽  
pp. 1-12
Author(s):  
Nina Jøranson ◽  
Christine Olsen ◽  
Giovanna Calogiuri ◽  
Camilla Ihlebæk ◽  
Ingeborg Pedersen
Keyword(s):  
Sleep Disturbances ◽  
Total Sleep Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sleep Time ◽  
Group Activity ◽  
Control Group ◽  
Randomized Controlled ◽  
People With Dementia ◽  
Cluster Randomized

ABSTRACT Objectives: Sleep disturbances are common in people with dementia and increase with the severity of the disease. Sleep disturbances are complex and caused by several factors and are difficult to treat. There is a need for more robust and systematic studies dealing with sleep disturbances in older people with dementia. The aim of this study was to investigate effects from robot-assisted (Paro) group activity on sleep patterns in nursing home (NH) residents with dementia. Design: A cluster randomized controlled trial. Setting: Special care units in 10 NH in Norway. Participants: A total of 60 participants over 65 years with dementia were recruited. Thirty participants were recruited to the intervention group and 30 participants to the control group. Intervention: Participants participated in group activity with Paro for 30 minutes twice a week over 12 weeks or in control group (treatment as usual). Measurements: Sleep–wake patterns were assessed objectively by 7 days of wrist actigraphy before and after the intervention. Data were collected between March 2013 and September 2014. Data were analyzed using mixed models. Results: Positive effects on change in sleep were found in the intervention group as compared with the control group. The intervention group increased percentage of sleep efficiency, increased the amount of total sleep time and reduced number of nocturnal awakenings. In addition, a significant effect was found in reduced awakenings after sleep onset. Conclusions: Social stimulation through engaging group activity could contribute to improved sleep in people with dementia in NH. Increased sleep efficiency and total sleep time, in addition to fewer night awakenings, affect central indicators of good sleep quality across the life span. Improved sleep quality will also affect quality of life and comorbidities in vulnerable groups. We believe group activity with Paro to be an accessible and feasible non-pharmacological treatment for those who enjoy Paro.

scholarly journals Comparison of ketorolac dosing in an emergency department setting

CJEM ◽  
2018 ◽  
Vol 20 (S2) ◽  
pp. S74-S77 ◽  
Author(s):  
Mercedeh Shanechi ◽  
Onyinyechi Eke ◽  
Michael Gottlieb
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Single Dose ◽  
Acute Pain ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Clinical Question ◽  
Randomized Controlled ◽  
Emergency Department Setting ◽  
Intravenous Ketorolac

Clinical questionDoes the analgesic effect of intravenous ketorolac differ if given in doses of 10, 15, or 30 mg to patients presenting to the emergency department with acute pain?Article chosenMotov S, Yasavolian M, Likourezos A, et al. Comparison of intravenous ketorolac at three single-dose regimens for treating acute pain in the emergency department: a randomized controlled trial. Ann Emerg Med 2017;70(2):177-84.

scholarly journals Effect of far infrared therapy on arteriovenous fistula maturation, survival and stenosis in hemodialysis patients, a randomized, controlled clinical trial: the FAITH on fistula trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
K. Lindhard ◽  
M. Rix ◽  
J. G. Heaf ◽  
H. P. Hansen ◽  
B. L. Pedersen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Arteriovenous Fistula ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Far Infrared ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Protective Mechanism ◽  
Randomized Controlled

Abstract Background An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment. After creation many of the AVFs will never mature or if functioning will need an intervention within 1 year due to an AVF stenosis. Studies investigating possible therapies that improves the AVF maturation and survival are scarce. Far infrared therapy (FIR) has shown promising results. In minor single centre and industry supported trials FIR has shown improved AVF maturation and survival. There is a need of a randomized multicentre controlled trial to examine the effect of FIR on the AVF maturation and survival and to explore the possible AVF protective mechanism induced by the FIR treatment. Methods This investigator initiated, randomized, controlled, open-labeled, multicenter clinical trial will examine the effect of FIR on AVF maturation in patients with a newly created AVF (incident) and AVF patency rate after 1 year of treatment in patients with an existing AVF (prevalent) compared to a control group. The intervention group will receive FIR to the skin above their AVF three times a week for 1 year. The control group will be observed without any treatment. The primary outcome for incident AVFs is the time from surgically creation of the AVF to successful cannulation. The primary outcome for the prevalent AVFs is the difference in number of AVFs without intervention and still functioning in the treatment and control group after 12 months. Furthermore, the acute changes in inflammatory and vasodilating factors during FIR will be explored. Arterial stiffness as a marker of long term AVF patency will also be examined. Discussion FIR is a promising new treatment modality that may potentially lead to improved AVF maturation and survival. This randomized controlled open-labelled trial will investigate the effect of FIR and its possible mechanisms. Trial registration Clinicaltrialsgov NCT04011072 (7th of July 2019).

Sign in / Sign up

Export Citation Format

Share Document