scholarly journals Efficacy of Levamisole with Standard Care Treatment vs Standard Care in Clinical Presentations of Non-Hospitalized Patients with COVID-19: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Hossein Asgardoon ◽  
Hamid Emadi koochak ◽  
Mohammad Hassan Kazemi-Galougahi ◽  
Ali Zare Dehnavi ◽  
Behzad Khodaei ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
General Health ◽  
Standard Care ◽  
Intervention Group ◽  
Health Condition ◽  
Hospitalized Patients ◽  
Care Group ◽  
Control Group ◽  
Significant Difference ◽  
General Health Condition

Abstract Introduction: Levamisole (LVM) demonstrated clinical benefit in a trial in patients with mild to moderate coronavirus disease 2019 (COVID-19), but its effect in a larger sample size needs to be confirmed. Methods In this randomized open-label trial, we enrolled non-hospitalized patients with mild to moderate COVID-19 at nine health centers in Tehran province, Iran, in 2021. Patients were randomly assigned to receive a 10-day course of LVM with standard care (n = 185), or standard care (n = 180) in a 1:1 ratio. On days 1 to 10, LVM was administered orally at a dosage of 50 mg. The participants were called and followed on days 1, 3, 5, 7, 9, and 14. The outcomes were general health condition, hospitalization rate, sign and symptoms, and adverse events (AEs). Generalized Estimating Equations model was used for analysis. Results Among 507 randomized patients, 473 started the experiment and received LVM in addition to standard care or received only the standard care (median age, 40 [IQR, 32-50.75] years; 164 [44.9%] women; 9.4% had diabetes, 8.8% hypertension, 1.6% cardiovascular disease), and 346 (98%) completed the trial. Compared to control group, LVM decreased the general health condition of the patients (B=-0.635; CI= -0.041, -0.329; P= 0.000). Patients in the LVM with standard care group had significantly lower odds of developing fever (OR= 0.260; 95% CI= ‎0.11‎‎3‎-0.59‎‎9‎; P = .002), chills (OR= 0.223; 95% CI= ‎‎0.07‎‎6‎-‎0.64‎‎8‎; P = 0.006), fatigue (OR= 0.576; 95% CI= ‎0.34‎‎6‎-‎0.96‎‎0‎‎; P = ‎0.034), and myalgia (OR= 0.54‎‎4‎; 95% CI= ‎0.31‎‎7‎-‎0.93‎‎2‎‎; P =0.027). During the therapy, there was no significant difference in the parameters of dyspnea, cough, diarrhea, nausea, vomiting, sore throat, hyposmia, dysgeusia, and anorexia (P > 0.05). No significant difference was observed in the rate of hospitalization. Although the intervention group had greater AEs than the control group, yet, the difference was not statistically significant. Conclusions LVM has clinical benefit in improving health condition of patients with mild to moderate COVID-19. Further studies are needed to confirm our findings. Trial Registration: Iranian Registry of Clinical Trials: IRCT20201124049480N1; Registration date: 28/03/2021.

scholarly journals A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nicole C. Gavin ◽  
Tricia M. Kleidon ◽  
Emily Larsen ◽  
Catherine O’Brien ◽  
Amanda Ullman ◽  
...  
Keyword(s):  
Standard Care ◽  
Dwell Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Care Group ◽  
Control Group ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Efficacy Trial

Abstract Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).

scholarly journals A Randomized Controlled Trial of Hydroxychloroquine as Prophylaxis for COVID-19 among Health Care Providers

2021 ◽  
Vol 14 (1) ◽  
pp. 600-604
Author(s):  
Ramin Parvizrad ◽  
Ghasem Mosayebi ◽  
Nader Zarinfar ◽  
Morteza Mousavi-Hasanzadeh ◽  
Seyedeh Zahra Razavi ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Controlled Trial ◽  
White Blood Cells ◽  
Intervention Group ◽  
Healthcare Services ◽  
Care Group ◽  
Control Group ◽  
Care Providers ◽  
Level Of Evidence ◽  
Significant Difference

Background: Although there is a growing consensus that hydroxychloroquine may not be effective in the treatment of COVID-19 patients, there is still little high-quality evidence about the prophylactic effects of this medication. In this study, we aimed to evaluate the efficiency of hydroxychloroquine in preventing COVID-19 infection among healthcare workers. Methods: In this clinical trial, 90 healthcare providers from two referral hospitals of COVID-19 were divided into the hydroxychloroquine group (400 mg/week for eight weeks) and the routine-care group. Serum CRP levels and the frequency of T-helper (CD4+ cells) and T-cytotoxic (CD8+ cells) were assessed at the beginning and end of the study. The groups were compared in terms of White Blood cells (WBCs), polymorph nuclear cells (PMNs), lymphocytes (LYM), hemoglobin (Hb), and platelets (Plt.). Results: The results revealed no significant differences between the two groups in terms of WBC, PMN, LYM, Hb, Plt., CD4, and CD8. The mean difference of the CD4:CD8 ratio showed a significantly higher decrease (P=0.05) in hydroxychloroquine group than in the control group (0.18 vs. 0.02). The incidence of COVID-19 was 15% (95%CI: 12-18%) in the control group and 10% (95%CI: 8-12%) in the intervention group; however, no significant difference was observed between the two groups in this regard (P=0.45). Conclusion: Our study findings boost an increasing level of evidence that hydroxychloroquine is not an effective prophylactic medication against COVID-19 and might even exacerbate the profile of pandemic containment efforts by adding more pain to patients’ life and healthcare services.

scholarly journals LO52: Distraction in the ED using Virtual reality for Intravenous Needs in Children to Improve comfort- DEVINCI - a pilot RCT

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S26-S26
Author(s):  
E. D. Trottier ◽  
E. Osmanlliu ◽  
B. Bailey ◽  
M. Lagacé ◽  
M. Certain ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Side Effects ◽  
Standard Care ◽  
Psychological Intervention ◽  
Intervention Group ◽  
Procedural Pain ◽  
Control Group ◽  
Group Standard ◽  
Memory Of Pain ◽  
Significant Difference

Introduction: Venipuncture is a frequent cause of pain and distress in the pediatric emergency department (ED). Distraction, which can improve patient experience, remains the most studied psychological intervention. Virtual reality (VR) is a method of immersive distraction that can contribute to the multi-modal management of procedural pain and distress. Methods: The main objectives of this study were to determine the feasibility and acceptability of Virtual Reality (VR) distraction for pain management associated with venipunctures and to examine its preliminary effects on pain and distress in the pediatric ED. Children 7-17 years requiring a venipuncture in the pediatric ED were recruited. Participants were randomized to either a control group (standard care) or intervention group (standard of care + VR). Principal clinical outcome was the mean level of procedural pain, measured by the verbal numerical rating scale (VNRS). Distress was also measured using the Child Fear Scale (CFS) and the Procedure Behavior Check List (PBCL) and memory of pain using the VNRS. Side effects were documented. Results: A total of 63 patients were recruited. Results showed feasibility and acceptability of VR in the PED and overall high satisfaction levels (79% recruitment rate of eligible families, 90% rate of VR game completion, and overall high mean satisfaction levels). There was a significantly higher level of satisfaction among healthcare providers in the intervention group, and 93% of those were willing to use this technology again for the same procedure. Regarding clinical outcomes, no significant difference was observed between groups on procedural pain. Distress evaluated by proxy (10/40 vs 13.2/40, p = 0.007) and memory of pain at 24 hours (2.4 vs 4.2, p = 0.027) were significantly lower in the VR group. Venipuncture was successful on first attempt in 23/31 patients (74%) in the VR group and 15/30 (50%) patients in the control group (p = 0.039). Five of the 31 patients (16%) in the VR group reported side effects Conclusion: The addition of VR to standard care is feasible and acceptable for pain and distress management during venipunctures in the pediatric ED. There was no difference in self-reported procedural pain between groups. Levels of procedural distress and memory of pain at 24 hours were lower in the VR group.

scholarly journals A Validation and Cost-Analysis Study of a Targeted School-Based Dental Check-Up Intervention: Children’s Dental Program

Children ◽  
2020 ◽  
Vol 7 (12) ◽  
pp. 257
Author(s):  
Tan Minh Nguyen ◽  
Bradley Christian ◽  
Sajeev Koshy ◽  
Michael Vivian Morgan
Keyword(s):  
Primary Schools ◽  
Null Hypothesis ◽  
Standard Care ◽  
Best Practice ◽  
Retention Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
School Based ◽  
Significant Difference

Background: Limited evidence exists to inform best practice approaches to implement school-based dental screening to address child retention via referral for dental services. This research tested the null hypothesis that a targeted school-based dental check-up program (intervention) has a 75% child retention rate for public dental care (H0 = 0.75). Methods: A prospective non-randomised controlled trial was conducted with a convenience sampling approach in metropolitan Melbourne, Australia. Children in the intervention group were recruited from two preschools and two primary schools from a low socioeconomic area. Children in the standard care group were recruited from the local public dental service. Statistical analysis was performed using Stata IC Version 12. Results: Children in the intervention (45%) were significantly less likely to have never had a dental check-up compared to standard care (20%) (p < 0.001). There was no significant difference for the child retention rate for the intervention group when compared against the null hypothesis (p = 0.954). The total society costs were AU$754.7 and AU$612.2 for the intervention and standard care groups, respectively (p = 0.049). Conclusions: This validation study provides evidence that a targeted school-based dental check-up program can achieve a 75% child retention rate and should be considered for program expansion.

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

TERAPI MUSIK DAN TINGKAT KECEMASAN PASIEN PREOPERASI

2016 ◽  
Vol 5 (1) ◽  
pp. 1-6
Author(s):  
Wenny Savitri ◽  
Nani Fidayanti ◽  
Paulus Subiyanto
Keyword(s):  
Music Therapy ◽  
Intervention Group ◽  
Complementary Therapy ◽  
T Test ◽  
Anxiety Level ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Music Intervention ◽  
Significant Difference ◽  
Anxiety Levels

Background: Surgery is one of medical interventions which can cause fear, anxiety, and stressed because of its effects toward the integrity of body and soul. Nurses have significant roles in any preoperative care which is helping patients to decrease preoperative anxiety by using complementary therapy. The use of music therapy as one of the complementary therapies is not common in Indonesia. Therefore, scientific studies to prove the role of this therapy to decrease the level of anxiety of pre-operative patients is needed. Objective: To investigate the effects of music therapy in reducing anxiety levels of preoperative patients. Methods: A quasy experimental study with pre-test and post-test design with control group was applied to 50 respondents from medical ward in Panembahan Senopati Hospital of Yogyakarta who met the inclusion criteria.Dara were then analyzed by using t-test statistical analysis. Results: The control group showed the increased value of anxiety level of0.8 without music intervention (t= - 1503, df = 24, p<.05), whereas the intervention group showed the decreased value of anxiety level of -5.52 (t=5.081, df=24, p<.05). Meanwhile the independent t-test results for both groups showed a significant difference between group (t= 3,373, df=48, p<.05). Conclusion: Music therapy has significant effect in reducing preoperative anxiety levels of patients. Keywords: anxiety, preoperative, music therapy

The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

2018 ◽  
Vol 7 ◽  
Author(s):  
Azita Kamjoo
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Singleton Pregnancy ◽  
Group Data ◽  
Significant Difference ◽  
Labor Length ◽  
Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

The Effectiveness of Using a Mobile Messenger as an Educational Supporting Tool among Nursing Students

2020 ◽  
Vol 4 (1) ◽  
pp. 67-77
Author(s):  
Rohimah Ismail ◽  
Chong Mei Chan ◽  
Wan Muhammad Azly W. Zulkafli ◽  
Hasnah Zani ◽  
Zainab Mohd Shafie
Keyword(s):  
Nursing Education ◽  
Nursing Students ◽  
Clinical Decision Making ◽  
Intervention Group ◽  
Great Influence ◽  
Control Group ◽  
P Value ◽  
Significant Difference ◽  
Supporting Tool ◽  
Nursing College

                The evolution of information technology has exerted great influence on nursing education via new pedagogy of knowledge delivery without time and place restriction. Mobile technology revolutionises nursing education and clinical practice via empowering skills of critical thinking and clinical decision-making through learning. The aim of this study is to evaluate the effectiveness of using mobile messenger (Whatsapp) as an educational supporting tool among nursing students. The study design used is a Cluster Randomized Control Trail. Two nursing colleges were selected. Sample size was 93 participants, 48 from the Kuala Terengganu Nursing College Kuala Terengganu as the intervention group while the control group were recruited among 45 participants from UniSZA Nursing College. There is a significant difference in the level of knowledge between pre and posttest among intervention group (mean difference was -8.70 with a standard deviation 8.42, p-value< 0.001) and 93.8 percent of the respondents perceived the usefulness of using WhatsApp mobile messenger to enhance learning. This demonstrates that learning through mobile messenger (WhatsApp) enhances learning and is well received as a new method of learning by almost all students.   Keywords: Mobile learning, WhatsApp messenger, Social Interaction

Comparison of the Effects of Fenugreek Vaginal Cream and Ultra Low- Dose Estrogen on Atrophic Vaginitis

2020 ◽  
Vol 17 (9) ◽  
pp. 815-822
Author(s):  
Maryam Safary ◽  
Sevil Hakimi ◽  
Noushin Mobaraki-Asl ◽  
Paria Amiri ◽  
Habib Tvassoli ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Low Dose ◽  
Intervention Group ◽  
Clinical Signs ◽  
Control Group ◽  
Conjugated Estrogens ◽  
Atrophic Vaginitis ◽  
Vaginal Cream ◽  
Intergroup Comparison ◽  
Significant Difference

Introduction: Atrophic vaginitis is a common problem in postmenopausal women and results from decreased levels of blood estrogen. It is associated with symptoms of itching, burning, dyspareunia, and postmenopausal bleeding. The present study evaluated the effects of fenugreek extract on atrophic vaginitis. Materials and Methods: This randomized controlled clinical trial was performed on 60 postmenopausal women in Ardabil, Iran, in 2018. The participants were selected using block randomization with the allocation ratio 1:1. Those in the intervention group received 0.5g (the applicator filled to the half-full mark) fenugreek vaginal cream 5% twice a week for 12 weeks. The control group received conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens. Atrophic vaginitis was evaluated before and after the treatment through clinical examination, clinical signs, and measurement of Vaginal Maturation Index (VMI). Findings: After the 12-week intervention and modification of the baseline score, the mean (standard error) score for atrophic vaginitis signs was 3.100 (1.43-4.75). This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001). VMI was less than 49% in 86.7% and 46.7% of the participants in the intervention and control groups, respectively. This was a significant difference in favor of the control group (p=0.001). Conclusion: The results of this study showed that total fenugreek extract could be effective in treating signs of atrophic vaginitis, but it was not as effective as ultra-low-dose estrogen.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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