scholarly journals The tiny effects of respiratory masks on physiological, subjective, and behavioral measures under mental load in a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Robert P. Spang ◽  
Kerstin Pieper
Keyword(s):  
Controlled Trial ◽  
Open Science ◽  
Blood Oxygen ◽  
Mental Load ◽  
Blood Oxygen Saturation ◽  
Randomized Controlled ◽  
Statistical Equivalence ◽  
Significant Difference ◽  
Behavioral Parameters ◽  
Science Framework

AbstractSince the outbreak of the coronavirus disease (COVID-19), face coverings are recommended to diminish person-to-person transmission of the SARS-CoV-2 virus. Some public debates concern claims regarding risks caused by wearing face masks, like, e.g., decreased blood oxygen levels and impaired cognitive capabilities. The present, pre-registered study aims to contribute clarity by delivering a direct comparison of wearing an N95 respirator and wearing no face covering. We focused on a demanding situation to show that cognitive efficacy and individual states are equivalent in both conditions. We conducted a randomized-controlled crossover trial with 44 participants. Participants performed the task while wearing an N95 FFR versus wearing none. We measured physiological (blood oxygen saturation and heart rate variability), behavioral (parameters of performance in the task), and subjective (perceived mental load) data to substantiate our assumption as broadly as possible. We analyzed data regarding both statistical equivalence and differences. All of the investigated dimensions showed statistical equivalence given our pre-registered equivalence boundaries. None of the dimensions showed a significant difference between wearing an FFR and not wearing an FFR.Trial Registration: Preregistered with the Open Science Framework: https://osf.io/c2xp5 (15/11/2020). Retrospectively registered with German Clinical Trials Register: DRKS00024806 (18/03/2021).

scholarly journals The Tiny Impact of Respiratory Masks - on Physiological, Subjective and Behavioral Measures under Mental Load

2020 ◽  
Author(s):  
Robert Spang ◽  
Kerstin Pieper
Keyword(s):  
Blood Oxygen ◽  
Mental Load ◽  
Blood Oxygen Saturation ◽  
Behavioral Measures ◽  
Public Places ◽  
Randomized Controlled ◽  
Statistical Equivalence ◽  
Significant Difference ◽  
Public Debates ◽  
Behavioral Parameters

Abstract Since the outbreak of the COVID-19 pandemic, the use of face masks is recommended to prevent droplets from traveling from one person to another. A commandment to wear masks applies in most public places to contain the widespread of the virus. Some public debates concern myths regarding risks caused by wearing a mask, like, e.g., decreased blood oxygen levels and impaired cognitive capabilities. The present, pre-registered study aims to contribute clarity by delivering a direct comparison of wearing an FFP2 (N95) respirator and wearing no mask. We focused on a demanding situation to show that cognitive efficacy and the person's state is equivalent in both conditions of a randomized-controlled cross-over study design. We measured physiological (blood oxygen saturation and heart rate variability), behavioral (parameters of performance in the task), and subjective (perceived mental load) data to substantiate our assumption as broad as possible. We analyzed data from 44 participants regarding both statistical equivalence and differences. All of the investigated dimensions showed statistical equivalence given our pre-registered equivalence boundaries. None of the dimensions showed a significant difference between wearing a mask and not wearing a mask.

scholarly journals The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

2019 ◽  
Vol 7 (7) ◽  
pp. 1088-1092
Author(s):  
Umi Budi Rahayu ◽  
Samekto Wibowo ◽  
Ismail Setyopranoto
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Functional Ability ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Berg Balance Scale ◽  
Early Mobilisation ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rémi Etienne ◽  
Myriam Laurent ◽  
Aline Henry ◽  
Antoine Bioy ◽  
Julia Salleron ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Rating Scales ◽  
Controlled Trial ◽  
Standard Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Numerical Rating ◽  
Reduction Of Pain ◽  
The Impact

Abstract Background Neuropathic pain is characterized by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment. Methods In a randomized, controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the “Standard group” (no intervention), “Hypnosis group”, in which a standardized hypnotic message was played during application, or the “Music group” in which relaxing music was played during application of the patch. Results Sixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423). Conclusions Listening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures. Trial registration NCT02822625.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Standard Care Versus Awake Prone Position in Adult Nonintubated Patients With Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Infection—A Multicenter Feasibility Randomized Controlled Trial

2021 ◽  
pp. 088506662110144
Author(s):  
Devachandran Jayakumar ◽  
Pratheema Ramachandran, DNB ◽  
Ebenezer Rabindrarajan, DNB ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan, MD ◽  
Nagarajan Ramakrishnan, AB ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Prone Position ◽  
Feasibility Study ◽  
Standard Care ◽  
Controlled Trial ◽  
Prone Positioning ◽  
Hypoxemic Respiratory Failure ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Hypoxic Respiratory Failure

Rationale: The feasibility and safety of awake prone positioning and its impact on outcomes in non-intubated patients with acute respiratory distress syndrome secondary to COVID-19 is unknown. Results of the observational studies published during this pandemic have been conflicting. In this context, we conducted a multi-center, parallel group, randomized controlled feasibility study on awake prone positioning in non-intubated patients with COVID-19 pneumonia requiring supplemental oxygen. Methods: 60 patients with acute hypoxic respiratory failure secondary to COVID-19 pneumonia requiring 4 or more liters of oxygen to maintain a saturation of ≥92% were recruited in this study. Thirty patients each were randomized to either standard care or awake prone group. Patients randomized to the prone group were encouraged to self-prone for at least 6 hours a day. The primary outcome was the proportion of patients adhering to the protocol in each group. Results: In the prone group, 43% (13 out of 30) of patients were able to self-prone for 6 or more hours a day. In the supine group, 47% (14 out of 30) were completely supine and 53% spent some hours in the prone position, but none exceeded 6 hours. There was no significant difference in any of the secondary outcomes between the 2 groups and there were no adverse events. Conclusions: Awake prone positioning in non-intubated patients with acute hypoxic respiratory failure is feasible and safe under clinical trial conditions. The results of our feasibility study will potentially help in the design of larger definitive trials to address this key knowledge gap.

scholarly journals Infectious Disease Team Review Using Antibiotic Switch and Discharge Criteria Shortens the Duration of Intravenous Antibiotic: A Single-Center Cluster-Randomized Controlled Trial in Thailand

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Thanyarak Wongkamhla ◽  
Buddharat Khan-asa ◽  
Sasima Tongsai ◽  
Nasikarn Angkasekwinai
Keyword(s):  
Infectious Disease ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Defined Daily Dose ◽  
Randomized Controlled ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Cluster Randomized ◽  
Discharge Criteria

Abstract Background Strategies have been recommended to optimize early antibiotic (ATB) switching from intravenous (IV) to oral ATB. This study aimed to determine whether infectious disease (ID) team review using ATB switch and discharge criteria would shorten the duration of IV ATB and length of hospital stay (LOS). Methods This cluster-randomized controlled trial was conducted in 8 general medical wards as cluster units at Siriraj Hospital during January–October 2019. The ID team review with checklist criteria was performed on the third, fifth, and seventh day of IV-ATB treatment to determine (1) the suitability of switching to oral ATB or outpatient parenteral ATB therapy and (2) early discharge for patients receiving IV-ATB versus control. The primary outcomes were LOS and the duration or days of therapy (DOT) or defined daily dose (DDD) of IV-ATB therapy. Results Four wards each were randomly assigned to the intervention and control groups (46 patients/cluster, 184 patients/arm). No significant difference was observed between intervention and controls for median duration of IV-ATB therapy (7 vs 7 days) and LOS (9 vs 10 days). A significantly shorter duration of IV ATB was observed in patients without sepsis in the intervention group when measured by DOT (7 vs 8 days, P = .027) and DDD (7 vs 9, P = .017) in post hoc analysis. Conclusions Infectious disease team review using checklist criteria did not result in a shorter duration of IV-ATB and LOS in overall patients. Further study is needed to determine whether faster culture turnaround time or advanced testing will reduce the duration of IV-ATB therapy.

Comparative Study on Vit. E & Mefenamic acid vs Mefenamic acid alone on mean reduction in pain in Primary Dysmenorrhea

2021 ◽  
Vol 15 (12) ◽  
pp. 3195-3197
Author(s):  
Fariha Sadiqa ◽  
Mufakhara Fatimah ◽  
Abdul Mudabbir Rehan ◽  
Sidra Mushtaq ◽  
Asia Firdous ◽  
...  
Keyword(s):  
Vitamin E ◽  
Mefenamic Acid ◽  
Controlled Trial ◽  
Acid Group ◽  
P Value ◽  
Primary Dysmenorrhea ◽  
High Concentration ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Menstrual Fluid

Background: Pelvic pain around the time of mensturation without any identifiable pathologic lesion present from menarche is called primary dysmenorrhea. The pain is believed to be related to prostaglandin (PG). Women with dysmenorrhoea have a relatively high concentration of PGF 2 alpha in menstrual fluid and suppression of PG synthesis has become the main treatment. Aim: To compare mean reduction in pain in patients presenting with primary dysmenorrhea given vitamin E & Mefenamic acid versus Mefenamic acid alone. Results: It was a randomized controlled trial which was conducted in Department of Obstetrics & Gynecology, THQ Raiwind Hospital, Lahore for 6 months duration w.e.f 01/02/2017 to 31/07/2017. In this study, 18(36%) in Vitamin-E group and 21(42%) in Mefenamic acid group were between 15-20 years while 32(64%) in Vitamin-E group and 29(58%) in Mefenamic acid group were between 21-25 years, mean±sd was calculated as 20.86±2.92 and 20.66±2.86 years respectively, mean dysmenorrheal pain at baseline was recorded as 50.06±10.27 in Vitamin-E group and 50.14±10.28 in Mefenamic acid group, p value < 0.754, showing that both groups are insignificant, mean dysmenorrheal pain after treatment was recorded as 20.50±10.04 in Vitamin-E group and 30.22±10.28 in Mefenamic acid group, p value was < 0.002 showing significant difference between the two group, comparison of mean reduction in dysmenorrheal pain after treatment was recorded as 20.56±0.91 in Vitamin-E group and 10.92±0.75 in Mefenamic acid group, p value was < 0.000, showing significant difference. Conclusion: We concluded that there is a significant mean reduction in dysmenorrhic pain in patients given Mefenamic Acid + Vitamen E as compared to patients given Mefenamic Acid alone. Keywords: Dysmenorrhic pain, Mefenamic Acid + Vitamen E, mean reduction in dysmenorrhic pain

Effect of Delayed Cord Clamping Reduced Anemic Outcome in Preterm Neonate

2021 ◽  
Vol 104 (5) ◽  
pp. 695-700
Keyword(s):  
Intraventricular Hemorrhage ◽  
Preterm Neonate ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Maternal Outcomes ◽  
Delayed Cord Clamping ◽  
Randomized Controlled ◽  
Cord Clamping ◽  
Significant Difference ◽  
The Mean

Objective: To compare the effects of immediate versus delayed cord clamping on neonatal outcomes in preterm neonates of gestational age of 32 to 36⁺⁶ weeks, and maternal outcomes. Materials and Methods: A randomized controlled trial was conducted in the Obstetrics and Gynecology Department at Bhumibol Adulyadej Hospital, in Bangkok, Thailand. The study compared the effects of immediate to delayed cord clamping at 60 seconds among preterm neonates born between 32 weeks, 0 day and 36 weeks, 6 days of gestation between August and October 2018. Results: The mean age of the participants was 26 years old, and half of the cases were nulliparous. One hundred ten women were randomly separated into two equal groups (n=55). Delayed cord clamping at 60 seconds increased hematocrit levels (Hct) in both two (p=0.004) and 48 (p<0.001) hours after delivery compared to the immediate cord clamping group. There were no differences in exposing the neonate to hypothermia, hypoxemia, Apgar score at 1-minute, polycythemia, intraventricular hemorrhage, hyperbilirubinemia, length of stay in hospital, and affecting the process of resuscitation. There were no statistical differences between the two groups in maternal outcomes such as retained placenta and postpartum hemorrhage. Conclusion: Delayed cord clamping at 60 seconds increased Hct in the newborn at two to 48 hours after birth. There was no significant difference in adverse maternal and neonatal complications within both groups. Keywords: Delayed cord clamping, Hematocrit, Preterm

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