scholarly journals The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
A. Kojaie-Bidgoli ◽  
F. Sharifi ◽  
F. Maghsoud ◽  
M. Alizadeh-Khoei ◽  
F. Jafari ◽  
...  
Keyword(s):  
Nursing Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Confusion Assessment Method ◽  
Aged Care ◽  
Assessment Method ◽  
Hospitalized Patients ◽  
Control Group ◽  
Double Blind ◽  
Hospital Elder Life Program

Abstract Background Hospital Elder Life Program (HELP) provides protocols based on factors for reducing delirium. Due to the lack of geriatric wards and aged care teams in Iran, it seems that some of the original HELP interventions need to be modified through a trial study. Hence, this study was conducted to determine whether the Iranian modified HELP could reduce delirium in geriatric hospitalized patients. Methods This double-blind randomized controlled trial was designed and conducted in a hospital at Kashan University of Medical Sciences in Iran. A total of 195 hospitalized patients aged ≥70 years, were 84 in the Intervention Group (IG) and 111 in the Control Group (CG). After assessing delirium risk factors, participants in the IG group received interventions based on the cognitive, vision/hearing, sleep, mobility, feeding, and hydration protocols by nursing students and the CG group received routine care. Delirium incidence was assessed by the Confusion Assessment Method. Delirium incidence, cognitive and functional abilities, frailty, fall, and length of stay were outcomes. Results The mean age of the patients was 78.53(Standard Deviation = 5.87) years. Delirium incidence was higher in the CG comparing to IG (14.71% vs 3.66%).Significant reduction observed in risk incidence of delirium because of interventions [Odds Ratio:0.124, Confidence Interval: 0.03–0.48]. Conclusion The modified HELP effectively reduced delirium rates in geriatric hospitalized patients. Trial registration This study was registered at the Iranian Registry of Clinical Trials IRCT20180910040995N1.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Anthropometric Indices ◽  
Double Blind ◽  
Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Positive Effect of Vitamin D and Magnesium Supplementation on Mental health Status of Attention-Deficit Hyperactive Children; A Randomized Double blind Controlled Clinical Trial

2020 ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Gholamreza Askari ◽  
Mahsa Malekahmadi
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Magnesium Supplementation ◽  
Double Blind

Abstract Background: Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in ADHD. The aim of this study is to determine the effect of Vitamin D and magnesium supplementation on mental health in children with ADHD.Method: This double‑blind, randomized controlled trial was performed on 66 ADHD children. participants were randomly allocated to receive both Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8 weeks. Strengths and difficulties questionnaire were used to evaluate children’s mental health at baseline and at the end of the study.Results: After 8 weeks of intervention, the serum levels of 25‑hydroxy‑Vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also a significant decrease in changes of emotional problems (p=0.001), conduct problems (p=0.002), peer problems (p=0.001), prosocial score (p=0.007), total difficulties (p=0.001), externalizing score (p=0.001), and internalizing score (p=0.001) was seen in intervention group at the end of study.Conclusion: Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation during 8-week could improve the behavioral function and mental health in ADHD. Although further well-designed studies with a larger sample size are needed.the IRCT registration: IRCT2016030326886N1.

scholarly journals The 3-Month Efficacy of Visual Art Training on Observational and Diagnostic Skills Among Nursing Students - A Randomized Controlled Trial

2021 ◽  
Author(s):  
Jia Guo ◽  
Qinyi Zhong ◽  
Ying Tang ◽  
Jiaxin Luo ◽  
Hongjuan Wang ◽  
...  
Keyword(s):  
Nursing Students ◽  
Visual Art ◽  
Controlled Trial ◽  
Phase 1 ◽  
Intervention Group ◽  
Traditional Education ◽  
Control Group ◽  
Master Program ◽  
Oil Paintings ◽  
Diagnostic Skills

Abstract Background: Visual art training is a student-led approach using Western art pieces as the main teaching resources. It has been developed and applied in nursing and medical education in the United States. This study aimed to adapt visual art training to Chinese cultural context, then to compare the efficacy of the culturally-tailored visual art training versus traditional education on observational and diagnostic skills at 3-month follow-up among Chinese nursing students in master program. Methods: This study included Phase 1 (cultural adaptation) and Phase 2 (3-month efficacy evaluation). It was conducted from June to September, 2019. In Phase 1, cultural barriers were identified and cultural adaptation strategy were made based on two focus group interviews. Phase 2 was a randomized controlled trial in a local museum. A total of 106 first-year nursing students in master program were randomized to the intervention group (visual art training composed of a field-guided museum visit with observation and debriefing of Chinese oil paintings and clinical images, plus traditional education) or the control group (traditional education). Data were collected for both groups at baseline and 3-month follow-up on the observational and diagnostic skills measured by clinical image tests. Satisfaction with the visual art training was investigated among staff and students respectively. Results: Observational skills of the intervention group increased significantly compared with the control group three months after the training (p < .001). A trend towards the improvement of diagnostic skills was indicated with increment of 2.92 points of the intervention group vs. 0.39 of the control group (p > .05). In general, all participants and staff were satisfied with the visual art training, especially the selected Chinese oil paintings and the student-led teaching process, but 34% (n = 18) were not satisfied with the long distance from the museum. Conclusions: A culturally-tailored visual art training with great acceptability and feasibility was implemented in China. It had a sustained positive effect on improving the observational skills of Chinese nursing students. This study can be used for a reference to introduce visual art training to nursing students or nurses from other cultures.Trial registration: Retrospectively registered in Chinese Clinical Trial Registry (ChiCTR2000037956) on 4th September, 2020.

scholarly journals The effect of triclosan-coated sutures on the rate of surgical site infection after hip and knee arthroplasty: a double-blind randomized controlled trial of 2546 patients

2018 ◽  
Vol 100-B (3) ◽  
pp. 296-302 ◽  
Author(s):  
A. P. Sprowson† ◽  
C. Jensen ◽  
N. Parsons ◽  
P. Partington ◽  
K. Emmerson ◽  
...  
Keyword(s):  
Surgical Site Infection ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Site Infection ◽  
Double Blind ◽  
Suture Group ◽  
Double Blinded ◽  
Complication Of Surgery

AimsSurgical site infection (SSI) is a common complication of surgery with an incidence of about 1% in the United Kingdom. Sutures can lead to the development of a SSI, as micro-organisms can colonize the suture as it is implanted. Triclosan-coated sutures, being antimicrobical, were developed to reduce the rate of SSI. Our aim was to assess whether triclosan-coated sutures cause a reduction in SSIs following arthroplasty of the hip and knee.Patients and MethodsThis two-arm, parallel, double-blinded study involved 2546 patients undergoing elective total hip (THA) and total knee arthroplasty (TKA) at three hospitals. A total of 1323 were quasi-randomized to a standard suture group, and 1223 being quasi-randomized to the triclosan-coated suture group. The primary endpoint was the rate of SSI at 30 days postoperatively.ResultsThe baseline characteristics of age, gender and comorbidities were well matched in the two groups. The rates of superficial SSI were 0.8% in the control group and 0.7% in the intervention group (p = 0.651), and when deep and superficial SSIs were combined the rates were 2.5% and 1.8 (p = 0.266). The length of stay in hospital and the rates of medical complications did not differ significantly between the groups (p = 1.000).ConclusionThis trial provided no evidence that the use of triclosan-coated sutures at THA and TKA leads to a reduction in the rate of SSI. Cite this article: Bone Joint J 2018;100-B:296–302.

scholarly journals Does problem-based learning education improve knowledge, attitude, and perception toward patient safety among nursing students? A randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Hossein Jamshidi ◽  
Masumeh Hemmati Maslakpak ◽  
Naser Parizad
Keyword(s):  
Patient Safety ◽  
Nursing Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Safety Education ◽  
Randomized Controlled ◽  
Attitudes And Perceptions ◽  
The Mean ◽  
Patient Safety Education

Abstract Background Patient safety is a top priority for any health care system. Most universities are looking for teaching methods through which they would be able to enhance students’ clinical decision-making capabilities and their self-centered learning to ensure safe and quality nursing care. Therefore, this study aimed to determine the effect of patient safety education through problem-based learning (PBL) on nursing students’ knowledge, attitude, and perceptions toward patient safety. Methods This randomized, controlled trial was conducted from September 2019 to January 2020. A total of 78 fourth-year nursing students participated in this study. The participants were randomly assigned to either the intervention group or the control group. In the intervention group, the educational materials were presented to the students using the PBL method during eight sessions of 45–60 min. In each control group, nursing students received eight education sessions through lectures and discussing the same educational content. Data were gathered 1 month after the intervention using demographic information and knowledge, attitudes, and perception questionnaires. Data were analyzed in SPSS ver. 22.0 using descriptive (mean and standard deviation) and inferential (chi-square test, independent t-test, paired t-test, and analysis of covariance (ANCOVA)) statistics. Results The results indicated that the difference in the mean scores of knowledge, attitudes, and perceptions of the nursing students about patient safety was statistically significant between the two groups after the PBL education (p = 0.001). The mean scores of students’ knowledge, attitude, and perceptions of patient safety increased significantly in the intervention group. Conclusions Implementing patient safety education through PBL positively affects knowledge, attitudes, and perceptions of patient safety among nursing students. Thus, the research team recommended the PBL method to be used by nursing professors to improve nursing students’ clinical skills and cognitive abilities to ensure safe patient care. Trial registration IRCT20190925044881N1; October 17, 2019.

scholarly journals Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial

2020 ◽  
Author(s):  
Gholamreza Farnoosh ◽  
Mostafa Akbariqomi ◽  
Taleb Badri ◽  
Mahdi Bagheri ◽  
Morteza Izadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adjunctive Therapy ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Control Group ◽  
Post Intervention ◽  
Double Blind ◽  
Baseline Health

Abstract Aim: To evaluate the clinical efficacy of adjuvant use of melatonin in patients with coronavirus disease 2019 (COVID-19). Methods: This single-center, double-blind, randomized clinical trial included 74 hospitalized patients with confirmed mild to moderate COVID-19 at Baqiyatallah Hospital in Tehran, Iran, from April 25, 2020 to June 5, 2020. Patients were randomly assigned in a 1:1 ratio to receive standard of care and standard of care plus melatonin at a dose of 3 mg three times daily for 14 days. Clinical characteristics, laboratory, and radiological findings were assessed and compared between two study groups at baseline and post-intervention. Safety and clinical outcomes were followed up for four weeks. Results: A total of 24 patients in the intervention group and 20 patients in the control group completed the treatment. Compared with the control group, the clinical symptoms such as cough, dyspnea, and fatigue, as well as the level of CRP and the pulmonary involvement in the intervention group had significantly improved (P < 0.05). The mean time of hospital discharge of patients and return to baseline health was significantly shorter in the intervention group compared to the control group (P < 0.05). No deaths and adverse events were observed in both groups during this study. Conclusions: Adjuvant use of melatonin has a potential to improve clinical symptoms of COVID-19 patients and contribute to a faster return of patients to baseline health. Keywords: COVID-19, Melatonin, Clinical trial, Adjunctive therapy Trial Registration: ClinicalTrials.gov Identifier: NCT04409522

scholarly journals Effects of Intravenous Lidocaine on Alfentanil Consumption During Procedural Sedation for Colonoscopy in Patients With Inflammatory Bowel Disease: a Randomized Controlled Trial

2020 ◽  
Author(s):  
Twan Aalbers ◽  
Sandra A.S. van den Heuvel ◽  
Ewald M. Bronkhorst ◽  
Aura A.J. van Esch ◽  
Gert Jan Scheffer ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Primary Objective ◽  
Procedural Sedation ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Lidocaine Group ◽  
Sedation And Analgesia ◽  
Inflammatory Bowel

Abstract Background: Procedural sedation and analgesia (PSA) is used during colonoscopy to facilitate the procedure and relieve patient’s discomfort. The foremost risk of PSA is respiratory depression. Lidocaine could be a promising additional analgesic in IBD patients to minimise side effects of PSA.Our primary objective was to investigate whether i.v. lidocaine reduces the amount of alfentanil used during PSA in IBD patients. Additionally, we investigated whether lidocaine reduces cardiorespiratory incidents and the amount of propofol required during the procedure.Methods: A randomised, double-blind, placebo controlled study was performed at the endoscopy unit of the Radboud University Medical Centre from November 2016 to December 2018. Seventy-six patients with IBD, ASA 1 or 2, between 18 and 65 years, scheduled for colonoscopy with PSA were included. Patients received lidocaine 1.5 mg kg-1 followed by a continuous infusion of 2 mg kg-1 h-1 (intervention group, n=38) or 0.9% saline in equivalent volumes (control group, n=38) during colonoscopy.Results: There was a reduction in the use of alfentanil (327µg (95%CI=-31-505, p=0.082)), and propofol (39 mg (95%CI=-5-83, p=0.083)) in the lidocaine group compared with the control group. Ten patients (26%) in the control group and 8 patients in the lidocaine group (21%) experienced a period of hypoxia (p=0.788). In both groups, no periods of hypotension were noted.Conclusion: Our investigation has shown a reduction in the use of propofol and alfentanil in patients undergoing colonoscopy with PSA. The differences were not statistically significant. Lidocaine did not reduces the incidence of cardiorespiratory events.Trial registration:EudraCT, 2016-002210-46, registered 19 may 2016,https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002210-46/resultsISRCTN, ISRCTN47787339, retrospectively registered 6 February 2019, http://www.isrctn.com/ISRCTN47787339

Sign in / Sign up

Export Citation Format

Share Document