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1.
Internet Interventions ; JOUR: 100585,
Article in English | ScienceDirect | ID: covidwho-2105148

ABSTRACT

Background As a result of the COVID-19 pandemic and its far-reaching impact, the prevalence of posttraumatic stress disorder (PTSD) symptoms is increasing significantly in China. Yet access to reliable and effective psychological treatment is still limited during the pandemic. The widespread adoption of mobile technologies may provide a new way to address this gap. In this research we will develop an Acceptance and Commitment Therapy (ACT) based intervention delivered by mobile application and will test its usability, efficacy, and mechanism of its effects in relieving PTSD symptoms. Methods A total of 147 Chinese participants with a diagnosis of PTSD according to the Clinician Administered PTSD Scale (CAPS-5) will be randomly assigned to an intervention group (app-delivered ACT), an active comparison group (app-delivered mindfulness), or a waitlist group. Participants in the intervention group or comparison group will use their respective apps for one month. Online self-report questionnaires will be used to assess the primary outcome of PTSD symptoms and the secondary outcomes symptoms of depression, symptoms of anxiety, and posttraumatic growth. The potential mediating variable to be tested is psychological flexibility and its components. These assessments will be conducted at baseline, at five times during treatment, at the end of treatment, and at 1- and 3-month follow-ups. Discussion As far as we know, this study is the first randomized controlled trial to investigate the usability, efficacy, and mechanism of an app-delivered ACT intervention for PTSD. Furthermore, the research will assess the effect of treatment in reducing dropout rates, explore effective therapeutic components, and investigate mechanisms of symptom change, which will be valuable in improving the efficacy and usability of PTSD interventions. Trial registration: ChiCTR2200058408.

2.
Complement Ther Med ; 71: 102900, 2022 Nov 11.
Article in English | MEDLINE | ID: covidwho-2104697

ABSTRACT

BACKGROUND: Some adverse events following immunization (AEFI) were observed in potential corelation with COVID-19 vaccination but without prevention or ongoing trial for it. We aimed to investigate efficacy of auricular acupressure (AuriAc) therapy in preventing AEFI after first dosage of the vaccine. METHODS: We performed a multicentre randomized controlled trial with three arms, including AuriAc, SAuriAc (sham auricular acupressure), and TrAsU (treatment as usual) group, carried out in four medical institutions in Chengdu, China, from March 17th to April 23rd, 2021. We enrolled participants based on eligibility criteria and randomized them into three groups: AuriAc (AEFI-specific auricular points applied, n = 52), SAuriAc (n = 51) or TrAsU (n = 44) group. Primary outcomes were percentages of any AEFI and local pain, and secondary outcomes were percentages who reported other AEFI. They were followed at 1, 3, 5, 7, and 14 days, by phone or online, with severity evaluated. RESULTS: 147 participants (73.47% females) were included with median age as 31 years (25-45, IQR). One day after the injection, participants in AuriAc group reported significant reduction on percentages of any AEFI [intention-to-treat, difference of percentage (DP) = -20.13, 95%CI: - 0.39, - 0.02, p = 0.01; per-protocol, DP = -22.21, 95%CI: - 0.40, - 0.03, P = 0.02] and local pain (per-protocol, DP = -18.40, 95%CI: -0.36, -0.01, P = 0.04), compared with TrAsU group. The effects were slight at other follow-up days and for other outcomes, and with a low percentage of mild local allergic reactions. CONCLUSIONS: We firstly explored potential of AuriAc for preventing AEFI related to COVID-19 vaccine injection, which is beneficial for the vaccine recipients, but evidence is limited. TRIAL REGISTRATION: chictr.org.cn no. ChiCTR2100043210 (http://www.chictr.org.cn/showproj.aspx?proj=121519).

3.
JMIR Form Res ; 6(11): e38460, 2022 Nov 02.
Article in English | MEDLINE | ID: covidwho-2098992

ABSTRACT

BACKGROUND: Psychiatric inpatients often have limited access to psychotherapeutic education or skills for managing anxiety, a common transdiagnostic concern in severe and acute mental illness. COVID-19-related restrictions further limited access to therapy groups on inpatient psychiatric units. App-based interventions may improve access, but evidence supporting the feasibility of their use, acceptability, and effectiveness in psychiatric inpatient settings is limited. MindShift CBT is a free app based on cognitive behavioral therapy principles with evidence for alleviating anxiety symptoms in the outpatient setting. OBJECTIVE: We aimed to recruit 24 participants from an acute general psychiatric inpatient ward to a 1-month randomized control study assessing the feasibility and acceptability of providing patients with severe and acute mental illness access to the MindShift CBT app for help with managing anxiety symptoms. METHODS: Recruitment, data collection, analysis, and interpretation were completed collaboratively by clinician and peer researchers. Inpatients were randomized to two conditions: treatment as usual (TAU) versus TAU plus use of the MindShift CBT app over 6 days. We collected demographic and quantitative data on acceptability and usability of the intervention. Symptoms of depression, anxiety, and psychological distress were measured in pre- and poststudy surveys for preliminary signals of efficacy. We conducted individual semistructured interviews with participants in the MindShift CBT app group at the end of their trial period, which were interpreted using a standardized protocol for thematic analysis. RESULTS: Over 4 weeks, 33 inpatients were referred to the study, 24 consented to participate, 20 were randomized, and 11 completed the study. Of the 9 randomized participants who did not complete the study, 7 were withdrawn because they were discharged or transferred prior to study completion, with a similar distribution among both conditions. Among the enrolled patients, 65% (13/20) were admitted for a psychotic disorder and no patient was admitted primarily for an anxiety disorder. The average length of stay was 20 days (SD 4.4; range 3-21) and 35% (7/20) of patients were involuntarily admitted to hospital. Small sample sizes limited accurate interpretation of the efficacy data. Themes emerging from qualitative interviews included acceptability and usability of the app, and patient agency associated with voluntary participation in research while admitted to hospital. CONCLUSIONS: Our study benefitted from collaboration between peer and clinician researchers. Due to rapid patient turnover in the acute inpatient setting, additional flexibility in recruitment and enrollment is needed to determine the efficacy of using app-based psychotherapy on an acute psychiatric ward. Despite the limited sample size, our study suggests that similar interventions may be feasible and acceptable for acutely unwell inpatients. Further study is needed to compare the efficacy of psychotherapeutic apps with existing standards of care in this setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT04841603; https://clinicaltrials.gov/ct2/show/NCT04841603.

4.
Trials ; 23(1): 332, 2022 Apr 21.
Article in English | MEDLINE | ID: covidwho-2098442

ABSTRACT

BACKGROUND: We conducted in-depth interviews to characterize reasons for COVID-19 vaccine hesitancy in emergency department (ED) patients and developed messaging platforms that may address their concerns. In this trial, we seek to determine whether provision of these COVID-19 vaccine messaging platforms in EDs will be associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. METHODS: This is a cluster-randomized controlled trial (RCT) evaluating our COVID-19 vaccine messaging platforms in seven hospital EDs (mix of academic, community, and safety-net EDs) in four US cities. Within each study site, we randomized 30 1-week periods to the intervention and 30 1-week periods to the control. Adult patients who have not received a COVID-19 vaccine are eligible with these exclusions: (1) major trauma, intoxication, altered mental status, or critical illness; (2) incarceration; (3) psychiatric chief complaint; and (4) suspicion of acute COVID-19 illness. Participants receive an orally administered Intake survey. During intervention weeks, participants then receive three COVID-19 vaccine messaging platforms (4-min video, one-page informational flyer and a brief, scripted face-to-face message delivered by an ED physician or nurse); patients enrolled during non-intervention weeks do not receive these platforms. Approximately, an hour after intake surveys, participants receive a Vaccine Acceptance survey during which the primary outcome of acceptance of the COVID-19 vaccine in the ED is ascertained. The other primary outcome of receipt of a COVID-19 vaccine within 32 days is ascertained by electronic health record review and phone follow-up. To determine whether provision of vaccine messaging platforms is associated with a 7% increase in vaccine acceptance and uptake, we will need to enroll 1290 patients. DISCUSSION: Highlighting the difficulties of trial implementation during the COVID-19 pandemic in acute care settings, our novel trial will lay the groundwork for delivery of public health interventions to vulnerable populations whose only health care access occurs in EDs. CONCLUSIONS: Toward addressing vaccine hesitancy in vulnerable populations who seek care in EDs, our cluster-RCT will determine whether implementation of vaccine messaging platforms is associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. TRIAL STATUS: We began enrollment in December 2021 and expect to continue through 2022. TRIAL REGISTRATION: ClinicalTrials.gov NCT05142332 . Registered 02 December 2021.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Emergency Service, Hospital , Humans , Randomized Controlled Trials as Topic
5.
Trials ; 23(1): 342, 2022 Apr 23.
Article in English | MEDLINE | ID: covidwho-2098441

ABSTRACT

BACKGROUND: Methamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions, and their implementation barriers in Vietnam. METHOD: Design: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions. PARTICIPANTS: We will recruit 600 participants in 20 methadone clinics. ELIGIBILITY CRITERIA: (1) age 16+; (2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores ≥ 10 for methamphetamine use or confirmed methamphetamine use with urine drug screening; (3) willing to provide three pieces of contact information; and (4) having a cell phone. OUTCOMES: Outcomes are measured at 13, 26, and 49 weeks and throughout the interventions. Primary outcomes include the (1) increase in HIV viral suppression, (2) reduction in HIV risk behaviors, and (3) reduction in methamphetamine use. COVID-19 response: We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity. DISCUSSION: This study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624.


Subject(s)
Amphetamine-Related Disorders , HIV Infections , Methamphetamine , Opioid-Related Disorders , Adolescent , Amphetamine-Related Disorders/diagnosis , COVID-19 , HIV Infections/prevention & control , Humans , Methadone/therapeutic use , Methamphetamine/adverse effects , Opioid-Related Disorders/diagnosis , Opioid-Related Disorders/drug therapy , Randomized Controlled Trials as Topic
6.
Transl Behav Med ; 2022 Nov 03.
Article in English | MEDLINE | ID: covidwho-2097457

ABSTRACT

Although the COVID-19 pandemic has increased the importance of digital technology in clinical trial implementation, there is a dearth of literature reporting on challenges and strategies related to multi-site randomized controlled trials (RCTs) among pediatric cancer survivors during the pandemic. This paper discusses challenges faced in the implementation of the NOURISH-T+ trial so far (December 2019-March 2022) and describes adaptations made as a result of these disruptions in the areas of recruitment, data collection, and overall engagement. This reflection is based on a multisite cluster-RCT that aims to examine whether an intervention targeting parents as agents of change to promote healthy eating and physical activity in pediatric cancer survivors, NOURISH-T+ (Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions), reduces body mass and improves health behaviors compared to Brief NOURISH-T (Enhanced Usual Care/EUC). The COVID-19 pandemic has created and exacerbated challenges for our trial related to participant recruitment and engagement, technology access and literacy, and data collection and management, as well as COVID-related challenges (e.g., Zoom fatigue). Strategies used to address these challenges might prove helpful in future virtual or hybrid RCTs, including developing trust and rapport with participants, providing support through multiple routes of dissemination, and using data management applications (e.g., REDCap™) for automation and project management. Extra efforts to build families' trust and rapport, offering multiple routes of support, and automating as many tasks as possible are critical to ensuring the continuation of high-quality clinical trials during the COVID-19 pandemic.


Challenges and strategies among research on pediatric cancer survivors during the COVID-19 pandemic have not been well described. Our intervention, NOURISH-T+ (Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions), aims to promote healthy eating and physical activity in pediatric cancer survivors. The COVID-19 pandemic has created challenges for our trial related to participant recruitment and engagement, technology, data collection, and management, and COVID-related challenges (e.g., Zoom fatigue). Strategies that have been helpful for us include developing trust and rapport with participants, providing support through multiple routes of dissemination (e.g., website, videos), and using data management applications (e.g., REDCap™) to optimize tasks.

7.
Open Forum Infect Dis ; 7(10): ofaa446, 2020 Oct.
Article in English | MEDLINE | ID: covidwho-2097427

ABSTRACT

BACKGROUND: Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. METHODS: We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. RESULTS: A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. CONCLUSIONS: In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.

8.
Phytomedicine ; 108: 154514, 2022 Oct 28.
Article in English | MEDLINE | ID: covidwho-2086622

ABSTRACT

BACKGROUND: A wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly resulted in a steep increase in the infected population and an overloaded healthcare system. Effective medications for Omicron are currently limited. The previous observational study supports the efficacy and safety of Reyanning (RYN) mixture in the treatment of coronavirus disease 2019 (COVID-19). PURPOSE: To evaluate the efficacy of RYN in asymptomatic and mildly infected patients with SARS-CoV-2 infection. STUDY DESIGN AND METHODS: This study was a prospective, open-label, randomized controlled trial. We consecutively recruited 2830 patients from Shanghai New International Expo Center mobile cabin hospital and randomized them in a 1:1 ratio to receive RYN plus standard care or receive standard care alone. The primary outcomes were the negative conversion of nucleic acid. Secondary outcomes included the hospital duration, new-onset symptoms, proportion of disease progression, and the viral load measured by the cycle threshold (Ct) value. RESULTS: A total of 1393 patients in the intervention group and 1407 patients in the control group completed the study. The negative conversion time of nucleic acid was significantly shortened in the intervention group (median: 6 d vs. 7 d, Hazard ratio: 0.768, 95CI %: 0.713-0.828, p < 0.0001). The negative conversion rate of nucleic acid was significantly higher in the intervention group (Day 3: 32.4% vs. 18.3%; Day7: 65.3% vs. 55.2%, p < 0.001). The hospitalization duration was significantly shortened in the intervention group (median: 8 d vs. 9 d, Hazard ratio: 0.759, 95% CI: 0.704-0.818, p < 0.0001). The proportion of new-onset fever (2.4% vs. 4.1%, p = 0.012), coughing (12.2% vs. 14.8%, p = 0.046), and expectoration (6.0% vs. 8.0%, p = 0.032) in the intervention group was significantly lower. RYN treatment increased Ct values and reduced the viral load. No disease progression and serious adverse events were reported during the study. CONCLUSION: RYN is a safe and effective treatment that can accelerate virus clearance and promote disease recovery in asymptomatic and mild Omicron infections.

9.
Trials ; 23(1): 875, 2022 Oct 14.
Article in English | MEDLINE | ID: covidwho-2079535

ABSTRACT

BACKGROUND: Since early 2022, patients with 2019 novel coronavirus (COVID-19) infection have increased rapidly in Shanghai, China. Nevertheless, there is no widely used unified rehabilitation treatment available for discharged patients with post-infection sequelae such as dyspnea, depression, and fatigue. To promote the rehabilitation of discharged patients, our team formulated Kangyi Qiangshen Gong exercise prescription on the basis of traditional Chinese medicine rehabilitation exercises (TCMRE). We designed a randomized controlled trial to evaluate the efficacy of rehabilitation and advantages of KQG for discharged patients with post-COVID-19 syndrome. METHODS/DESIGN: This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. In total, 60 discharged patients with COVID-19 sequelae, aged from 20 to 80 years will be recruited and randomly assigned to the World Health Organization instructed breathing techniques (BT) group and the Kangyi Qiangshen Gong exercise prescription (KQG) group at a ratio of 1:1. The patients in the BT group will perform breathing techniques exercise, and the patients in the KQG group will perform KQG exercise. Both groups will perform exercises twice a day for 3 months. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Modified Borg Scale, Fatigue Scale-14, Patient Health Questionnaire-9 Scale, Pittsburgh Sleep Quality Index, and the Respiratory Symptoms Scale. Clinical scales will be assessed at three points (pre-exercise, 3 months post-exercise, and 3 months follow-up). Adverse events will be recorded for safety assessment. DISCUSSION: This trial will serve high-quality evidence of the value of KQG for treating discharged patients with COVID-19 in rehabilitation period. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200059504. Registered on 03 May 2022. DISSEMINATION: The results will be published in peer-reviewed journals and disseminated through the study's website, and conferences.


Subject(s)
COVID-19 , COVID-19/complications , China , Dyspnea/etiology , Exercise Therapy/adverse effects , Fatigue , Humans , Prescriptions , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome
10.
Trials ; 23(1): 242, 2022 Mar 29.
Article in English | MEDLINE | ID: covidwho-2079532

ABSTRACT

BACKGROUND: The rapidly increasing number of elderly (≥ 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDH METHODS: In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024. DISCUSSION: The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. TRIAL REGISTRATION: Nederlands Trial Register (NTR), Trial NL9012 . CLINICALTRIALS: gov, Trial NCT04648436 .


Subject(s)
Brain Injuries, Traumatic , COVID-19 , Hematoma, Subdural, Acute , Aged , Hematoma, Subdural, Acute/diagnosis , Hematoma, Subdural, Acute/surgery , Humans , Multicenter Studies as Topic , Neurosurgical Procedures , Randomized Controlled Trials as Topic , Trauma Centers
11.
Phytother Res ; 2022 Oct 18.
Article in English | MEDLINE | ID: covidwho-2075146

ABSTRACT

Although plenty of clinical trials have confirmed the efficacy and safety of integrated traditional Chinese and Western medicine (ITCWM) against COVID-19, the role of ITCWM remains controversial. So we conducted a systematic review and meta-analysis of published studies in eight major databases that report the outcomes of interest in COVID-19 patients receiving ITCWM. RevMan5.4 software was used for meta-analysis, while the quality of RCTs was assessed by the Cochrane risk of bias tool and the retrospective studies were assessed by Newcastle-Ottawa Scale. Eventually, a total of 53 studies with 5425 COVID-19 patients was identified. The meta-analysis results showed that ITCWM was significantly better than western medicine treatment (WMT) alone in the percentage of cases changing to severe/critical [RR = 0.40, 95%CI (0.33, 0.49), p < .00001, I2  = 10%], overall clinical effectiveness [RR = 1.26, 95% CI (1.18, 1.35), p < .00001, I2  = 50%], time to defervescencer [MD = -1.45, 95% CI (-1.82, -1.07), p < .00001, I2  = 83%], disappearing time of cough [MD = -2.11, 95% CI (-2.98, -1.25), p < .00001, I2  = 93%], time of RT-PCR negativity [MD = -3.35, 95% CI (-4.74, -1.95), p < .00001, I2  = 92%], length of hospital stay [MD = -4.05, 95% CI (-5.24, -2.85), p < .00001, I2  = 91%], improvement in CT scan [RR = 1.22, 95% CI (1.17, 1.28), p < .00001, I2  = 46%], TCM syndrome score [MD = -3.95, 95% CI (-5.07, -2.82), p < .00001, I2  = 92%], disappearance rate of fever [RR = 1.23, 95% CI (1.10, 1.38), p < .00001, I2  = 85%], disappearance rate of cough [RR = 1.43, 95% CI (1.25, 1.63), p < .00001, I2  = 60%], level of CRP [MD = -9.23, 95% CI (-10.94, -7.52), p < .00001, I2  = 97%], and WBC [MD = -9.23, 95% CI (-10.94, -7.52), p < .00001, I2  = 97%]. There is no significant difference between ITCWM and WMT in the adverse reaction rate [RR = 0.85, 95% CI(0.71, 1.03), p = .10, I2  = 25%]. Our results showed evidence of clinical efficacy and safety benefit in COVID-19 patients treated with ITCWM. In spite of some limitations, the rapidly developing global pandemic warrants further high-quality and multicenter clinical studies to confirm the contribution of ITCWM.

12.
Nutrition & Food Science ; 2022.
Article in English | Web of Science | ID: covidwho-2070250

ABSTRACT

Purpose Today, coronavirus disease-19 (COVID-19) treatment is an evolving process, and synbiotic administration has been suggested as a new therapeutic strategy. This study aims to investigate the effect of synbiotic supplementation in COVID-19 patients. Design/methodology/approach In this placebo-controlled trial, 80 patients were randomized to receive oral synbiotic capsule (containing fructooligosaccharide and seven bacterial strains;Lactobacillus (L) casei, L. rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, L. acidophilus, Bifidobacterium longum, L. bulgaricus, each one 109 colony-forming units) or placebo for two months. Inflammatory markers (Interleukin-6 [IL-6], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]) and white blood cell (WBC) count were evaluated at two timepoints (baseline, two months later). The measured variables were adjusted for confounders and analyzed by SPSS v21.0. Findings All 80 enrolled patients completed the study. The study adherence was good (approximately 70%). The mean changes for IL-6 were not significant (Delta = -0.6 +/- 10.4 pg/mL vs Delta = +11.2 +/- 50.3 pg/mL, p > 0.05). There were no significant improvements for CRP, ESR and WBC. Originality/value Administration of synbiotics for two months did not improve inflammatory markers in COVID-19 patients.

13.
Front Med (Lausanne) ; 8: 733724, 2021.
Article in English | MEDLINE | ID: covidwho-2071098

ABSTRACT

Background: Randomized controlled trials (RCTs) evaluating the influence of personal protective equipment (PPE) on quality of chest compressions during cardiopulmonary resuscitation (CPR) showed inconsistent results. Accordingly, a meta-analysis was performed to provide an overview. Methods: Relevant studies were obtained by search of Medline, Embase, and Cochrane's Library databases. A random-effect model incorporating the potential heterogeneity was used to pool the results. Results: Six simulation-based RCTs were included. Overall, pooled results showed that there was no statistically significant difference between the rate [mean difference (MD): -1.70 time/min, 95% confidence interval (CI): -5.77 to 2.36, P = 0.41, I 2 = 80%] or the depth [MD: -1.84 mm, 95% CI: -3.93 to 0.24, P = 0.11, I 2 = 73%] of chest compressions performed by medical personnel with and without PPE. Subgroup analyses showed that use of PPE was associated with reduced rate of chest compressions in studies before COVID-19 (MD: -7.02 time/min, 95% CI: -10.46 to -3.57, P < 0.001), but not in studies after COVID-19 (MD: 0.14 time/min, 95% CI: -5.77 to 2.36, P = 0.95). In addition, PPE was not associated with significantly reduced depth of chest compressions in studies before (MD: -3.34 mm, 95% CI: -10.29 to -3.62, P = 0.35) or after (MD: -0.97 mm, 95% CI: -2.62 to 0.68, P = 0.25) COVID-19. No significant difference was found between parallel-group and crossover RCTs (P for subgroup difference both > 0.05). Conclusions: Evidence from simulation-based RCTs showed that use of PPE was not associated with reduced rate or depth of chest compressions in CPR.

14.
J Sch Psychol ; 95: 58-71, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2069404

ABSTRACT

The current study addressed the need for experimental research on Restorative Practices (RP) in its evaluation of the Morningside Center for Teaching Social Responsibility's Whole School RP Project. The study was conducted in a large Northeastern city using a cluster randomized controlled design in 18 elementary, middle, and high schools. In a single year, before the COVID-19 pandemic, and with data from 5878 students, the study found that overall, students in the RP Project schools were less likely to receive a discipline incident record (11.1%) as compared to students in the comparison schools (18.2%). However, differential treatment effects based on sex, race/ethnicity, and disability status were not found. The findings suggest prevention efforts are a cornerstone of practice/policy reforms to reduce the use of exclusionary discipline. Findings also suggest multi-year initiatives are needed to address discipline disparities.


Subject(s)
COVID-19 , Pandemics , Humans , COVID-19/prevention & control , Schools , Students , Ethnicity
15.
Pakistan Journal of Medical and Health Sciences ; 16(8):24-26, 2022.
Article in English | EMBASE | ID: covidwho-2067738

ABSTRACT

Aim: To evaluate the potential use of ivermectin with standard therapy among mild to moderate covid-19 illness. Methods: This is a single-centered, prospective observational, randomized, parallel group (1:1 ratio), standard versus controlled ivermectin study recruited 210 confirmed COVID-19 positive patients who were admitted in COVID treatment center of Dr Ruth Kum Pafu Civil hospital Karachi, Pakistan from 1st November 2020 to 30th May 2021. Data were analyzed using SPSS version Results: Total of 210 patients were enrolled in the study and aged matched patients were divided in two groups 105 patients received ivermectin 6 mg twice a day for five days along with standard therapy while remaining 105 patients received standard therapy as per local and international guidelines. Male were 140(66.7%) and female 70(33.3%);age ranges between 26 to 77 years and majority 140( 66.7%) were more than 50 years of age. Fever, dry cough and dyspnea were the major symptoms seen;112(53.3%) patients had DM as a comorbid illness . Total of 21(20%) of 105 patients of ivermectin group had negative PCR for COVID 19 on day seven while the other group had positive covid test in all of 105 patients . On day 10 total of 49 more patients from ivermectin group found COVID negative along with 21 previously negative had second PCR was found negative in this way total of 70( 66.7%) of ivermectin group had negative PCR for COVID 19 while 21(20%) patients from non ivermectin got negative PCR for COVID 19 on day 10 . Conclusion: Use of ivermectin with standard therapy clear the virus earlier than standard therapy in mild to moderate COVID-19 infected patients admitted in COVID treatment center of Dr Ruth Kum Pafu Civil Hospital Karachi.

16.
Aging Medicine and Healthcare ; 13(3):132-138, 2022.
Article in English | EMBASE | ID: covidwho-2067646

ABSTRACT

Background/Purpose: Due to the pandemic of COVID-19 and the need to pay attention to the older adults as one of the most vulnerable groups, this study aimed to determine the effects of educational programs based on the Protection Motivation Theory (PMT) as non-pharmaceutical intervention in promoting protective behaviors against COVID-19 among the older adults in Hamadan. Method(s): The present study was a randomized controlled trial performed in 2021 on 80 older adults visiting retirement centers in Hamadan. Participants were randomly assigned to experimental (n=40) and control groups (n=40). The data collection tool was a researcher-made questionnaire including demographic variables and constructs of PMT which were completed before and two months after the intervention. The intervention consisted of four sessions implemented for the experimental group. The collected data was analyzed in SPSS-16 using Chi-square, Mann-Whitney, and Wilcoxon tests. Result(s): There was no significant difference between the two groups in terms of all demographic variables and theoretical constructs before the educational intervention. After the educational intervention, there was a significant difference in the constructs of perceived severity (P=0.012), perceived response efficiency (P=0.009), perceived self-efficacy (P=0.021), and perceived response cost (P <0.001) after the intervention. No significant changes were reported in the control group (P >0.05). Also, results showed that there was no significant difference in the mean of COVID-19 preventive behaviors between the two groups after the educational intervention (P >0.05). Conclusion(s): The results showed that the use of educational intervention as non-pharmaceutical intervention based on the PMT was an effective approach to perform preventive behaviors against infectious diseases such as COVID-19. Copyright © 2022, Full Universe Integrated Marketing Limited. All rights reserved.

17.
NeuroQuantology ; 20(10):9468-9476, 2022.
Article in English | EMBASE | ID: covidwho-2067327

ABSTRACT

Objectives: Some of the problems during the COVID-19 pandemic identified include delay in the distribution of contraception to the clients, and poor monitoring and evaluation of activities for the family planning program. These problems which occurred from task conflict would need to be managed so that the objectives of the family planning program could be achieved. The purpose of this study was to analyze the influence of conflict management on performance of family planning program Lamongan Indonesia. Methods: This was an observation study with a longitudinal prospective time series design. Thirty randomly selected teams from a total of 33 family planning program teams from both studied organizations in Lamongan were interviewed and observed. Structured questionnaires had been used while some data were obtained from the management. Data were then analyzed using liner regression. Results: There were few issues identified that had led to conflicts among the family planning program teams. The scored conflicts are in the unfavorable category with an average of 12.70 (t1), 13.13 (t2) and 13.73 (t3). Levene’s test showed that the data variants of conflict management for three periods were homogeneous (Sig. > 0.05). The beta coefficient value indicates that conflict management has a strong influence on inter-team family planning program performance of 0.581( p= 0.001). Conclusions: Conflicts between two organizations with the same goal should be managed as it can help to achieve the required performance. Policy on conflict identification and management should be developed in any health program.

18.
Indian Journal of Occupational and Environmental Medicine ; 26(3):157-164, 2022.
Article in English | EMBASE | ID: covidwho-2066866

ABSTRACT

Background: Self-negligence, societal neglect, and lack of access to adequate health care make domestic workers vulnerable to ill-health. COVID-19 has adversely affected the work prospects of people across social classes and their health care-seeking opportunities as well. We studied the impact of COVID-19 pandemic on work prospects and health care-seeking behavior of a vulnerable section of the society-the women domestic workers. Method(s): A longitudinal analysis on 292 randomly selected women domestic workers residing in slums of 'Kalikapur' locality of Kolkata city, West Bengal (India). Data were collected using a predesigned and pretested schedule twice: in early-2020 (before severe impact of COVID-19) and mid-2020 (during the pandemic ravaging India). Paired t-test and McNemar's test were used to check for significant changes. Result(s): Of all the participants, 57.2% lost jobs partially while 2.7% were completely jobless in mid-2020;the average daily work-hour decreased by 25.7%. Their average monthly pay significantly reduced (P < 0.05);mean family income in mid-2020 was lesser as well, compared to earlier (P < 0.05). Compared to early-2020, 15.8% more participants were sole bread-winners for their families during COVID-19. Number of participants visiting health practitioners significantly reduced (P < 0.05) in mid-2020. Rise in over-the-counter medicine use (P < 0.05) and increased tendency to ignore symptoms (P < 0.05) during COVID-19 was noted. Conclusion(s): The COVID-19 pandemic has affected work prospects and health care-seeking behavior of women domestic workers negatively. Most of them faced wage reduction, many becoming sole-earners for their families. This necessitates continued formulation and implementation of strategies ensuring social benefits including healthcare. Awareness about affordable healthcare and ill-effects of bad practices like self-medication should also be built. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

19.
Pharmaceutical Journal ; 307(7955), 2022.
Article in English | EMBASE | ID: covidwho-2065008
20.
Int J Environ Res Public Health ; 19(19)2022 Oct 08.
Article in English | MEDLINE | ID: covidwho-2066080

ABSTRACT

Resilience training is gaining attention as a strategy to build students' resistance to adversity and promote their mental well-being. However, owing to inconsistencies and variations in the content and delivery of resilience training, more work is needed to examine students' experiences and preferences to address issues relating to intervention fidelity. This study adopted a qualitative approach in exploring students' experience of synchronous and asynchronous versions of a digital resilience training program. Seventeen students were interviewed using a semi-structured virtual face-to-face interview via Zoom. The thematic analyses unveiled four themes: embarking on a journey toward resilience, discovering strategies to develop resilience, finding a balance to benefit from resilience skill enhancement, and instilling resilience in the everyday. Future resilience training should consider students' workload and interactivity to enhance their engagement. As being resilient is associated with better mental well-being, the findings of this study may support the development of future wellness programs.


Subject(s)
COVID-19 , Resilience, Psychological , COVID-19/epidemiology , Humans , Mental Health , Problem Solving , Students
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