Efficacy of a Self-Hypnotic Relaxation App on Pain and Anxiety in a Randomized Clinical Trial: Results and Considerations on the Design of Active and Control Apps

2021 ◽  
pp. 1-19
Author(s):  
Elvira V. Lang ◽  
William Jackson ◽  
Paul Senn ◽  
Donavon Khosrow K. Aroni ◽  
Matthew D. Finkelman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Clinical Trial Results ◽  
And Control

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

scholarly journals A systematic review of convalescent plasma treatment for COVID19

2020 ◽  
Author(s):  
Ville N. Pimenoff ◽  
Miriam Elfström ◽  
Joakim Dillner
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Recovery Time ◽  
Clinical Trial Data ◽  
Poisson Model ◽  
Clinical Report ◽  
Prolonged Recovery ◽  
Report Data ◽  
Using Data ◽  
Clinical Trial Results

ABSTRACTBackgroundTransfusion of convalescent immune plasma (CP) is commonly used in epidemics. Several articles now describe clinical report data of CP for treatment of SARS-CoV-2-induced COVID-19 disease.MethodsA systematic literature review was conducted using the NCBI curated COVID-19 related open-resource literature database LitCovid to identify studies using CP as treatment for COVID-19 patients. We retrieved and curated all COVID-19 related patient and treatment characteristics from previously reported studies. A Poisson model was developed to evaluate the association between age of the patients, older age being the most common risk factor for COVID-19 mortality, and recovery time since CP treatment using data extracted from the literature.ResultsFrom 18,293 identified COVID-19 related articles, we included ten studies reporting results of CP treatment for COVID-19 from a total of 61 patients. Decreased symptoms of severe COVID-19 and clearance of SARS-CoV-2 RNA were the most direct observations. We found that patients over the age of sixty who received CP treatment for COVID-19 had a significantly prolonged recovery estimated by viral clearance (from 10 to 29 days since first dose of CP) compared to younger patients, who recovered from the infection in less than a week after receiving CP treatment.ConclusionsLimited published results on plasma transfusion treatment for COVID-19 disease with concomitant treatments suggest that CP therapy for COVID-19 is well tolerated and effective. First randomized clinical trial results, however, revealed no improvements in recovery time for elderly patients with severe COVID-19 between standard treatment alone and added with convalescent plasma. Accordingly, we argue that older patients may need a significantly longer time for recovery. Further randomized clinical trial data for COVID-19 with rigorous ethical standards is urgently needed.

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals Application of the Reverse Fragility Index to Statistically Nonsignificant Randomized Clinical Trial Results

2020 ◽  
Vol 3 (8) ◽  
pp. e2012469
Author(s):  
Muhammad Shahzeb Khan ◽  
Gregg C. Fonarow ◽  
Tim Friede ◽  
Noman Lateef ◽  
Safi U. Khan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Fragility Index ◽  
Clinical Trial Results

scholarly journals Effect of deep breathing exercise on oxygenation of patients under major abdominal surgery: randomized clinical trial

2021 ◽  
pp. 8-16
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Abdominal Surgery ◽  
Randomized Clinical Trial ◽  
T Test ◽  
Major Abdominal Surgery ◽  
Deep Breathing ◽  
Breathing Exercise ◽  
And Control ◽  
Experimental Group

Introduction: The number of major abdominal surgical procedures is increasing around the world. A large number of the patients complain about postoperative pulmonary complications (PPCs) after abdominal surgery and show symptoms of breathing pattern disorder. Therefore, this study aimed to investigate the effect of deep breathing exercise on the oxygenation of patients undergoing major abdominal surgery. Methods: This single-blind randomized clinical trial was conducted on 40 patients who needed major abdominal surgery in Qom, Iran, in 2014. The participants were divided into two equal experimental (n=20) and control (n=20) groups. The cases in both groups received routine care, however, those in the experimental group exercised repeated deep breathing four times per hour for two consecutive hours after the surgery as well. The condition of the patients in both groups was similar in terms of position, mobility, and oxygen therapy. The patient’s oxygen saturation, respiratory rate (RR), heart rate, and the severity of pain in the surgery site were measured. The collected data were analyzed in SPSS software (Version. 18) using paired t-test, independent t-test, Mann-Whitney U test, Wilcoxon rank-sum test, Multiple regression analyses, Chi-square test, and Fischer’s exact test. A p-value less than 0.05 was considered statistically significant. Results: Based on the study findings, the deep breathing exercise significantly reduced the surgery site pain and mean blood pressure and increased O2 saturation in the experimental group after the intervention (P<0.05). Moreover, there was a statistically significant difference between the experimental and control groups, and a significantly higher O2 saturation was observed in the experimental group after deep breathing exercise post-operation (β=2.01, P<0.001). Conclusion: Deep breathing exercises can reduce the severity of pain in the surgery site and mean arterial blood pressure and increase O2 saturation in patients after major abdominal surgery.

scholarly journals Evaluating the Effects of Spraying Oxytetracycline on Diabetic Foot Ulcers: A Randomized Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Gholam Hosein Kazemzadeh ◽  
Hasan Ravari ◽  
Masomeh Nabavizadeh ◽  
Saeid Pasban Noghabi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Purulent Discharge ◽  
Foot Ulcers ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers ◽  
Significant Difference ◽  
And Control

Background: Diabetic foot ulcers (DFUs) can be created due to neuropathy and peripheral vascular disease in the lower limbs. Objectives: This study aimed to evaluate the effects of spraying oxytetracycline on DFU. Methods: This randomized clinical trial was conducted on 60 diabetic patients suffering from DFU. The patients were randomly assigned into two equal groups of intervention and control (n = 30 each). While all subjects received antibiotic therapy, blood sugar control, and, if necessary debridement, the intervention group received oxytetracycline spraying on the DFUs twice a day. After the intervention, the patients were visited every week (for three weeks), photos were taken of the DFUs by special software, and the size of the DFUs was checked. The DFUs were also studied in terms of purulent discharge, the smell, and erythema, and edema around the ulcer. After three weeks, the healing of ulcers were compared in the two groups. Data were gathered and analyzed using the SPSS software version 11.5, descriptive statistical test, chi-square, and t-test. Results: Before the study, the size of the DFUs in the intervention and control groups was 110.87 ± 38.3 and 127.12 ± 40 mm2, respectively. After the treatment, the alterations in the intervention group in the first, second, and third weeks were 14.90 ± 14.41, 26.93 ± 18.86, and 41.25 ± 19.51, respectively. Also, in the control group, the alterations were 19.45 ± 1.35, 23.78 ± 5.31, and 13.29 ± 8.75, respectively. There was a statistically significant difference in the size of DFUs between the two groups (P < 0.05). Conclusions: According to the results, spraying oxytetracycline on DFUs facilitated the process of healing. Thus, it can be used as an affordable, available, and effective method.

scholarly journals El rey a examen. Lectura crítica de estudios sobre tratamiento.

2019 ◽  
Vol 10 (12) ◽  
pp. 4
Author(s):  
Manuel Molina
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Causal Relationship ◽  
Critical Review ◽  
Basic Design ◽  
Analytical Design ◽  
And Control ◽  
Ensayo Clínico ◽  
Quality Evidence

El ensayo clínico aleatorizado es el diseño ideal para resolver las preguntas sobre tratamiento. La lectura crítica de estos trabajos valorará su validez metodológica, la importancia de los resultados y su aplicabilidad a nuestra práctica clínica. Para ello, habrá que examinar los aspectos fundamentales del ensayo, tales como aleatorización, enmascaramiento y seguimiento. ABSTRACT   Testing the King. Critical review about treatment studies.   The randomized clinical trial is an interventional and analytical design, with antegrade direction and concurrent temporality, with sampling of a closed cohort and control of the exposure. It is the most appropriate design to assess the effectiveness of a treatment and the only that provides higher quality evidence to demonstrate the causal relationship between the intervention and the observed results. We review its structure, its association and impact measures and some variations of its basic design.  

Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy

2020 ◽  
Vol 130 (1) ◽  
pp. 32-37
Author(s):  
Mojtaba Maleki Delarestaghi ◽  
Aslan Ahmadi ◽  
Fatemeh Dehghani Firouzabadi ◽  
Maryam Roomiani ◽  
Mohammad Dehghani Firouzabadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Total Laryngectomy ◽  
Recovery Time ◽  
Low Pressure ◽  
Control Group ◽  
Pharyngocutaneous Fistula ◽  
Significant Difference ◽  
Drain Group ◽  
And Control

Objective: Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. Methods: The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. Results: The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P < .05). There was no significant difference between the groups in time to recovery from PCF. Conclusion: The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.

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