A musical intervention for respiratory comfort during noninvasive ventilation in the ICU

Discomfort associated with noninvasive ventilation (NIV) may participate in its failure. We aimed to determine the effect of a musical intervention on respiratory discomfort during NIV in patients with acute respiratory failure (ARF).An open-label, controlled trial was performed over three centres. Patients requiring NIV for ARF were randomised to either a musical intervention group (where they received a musical intervention and were subjected to visual deprivation during the first 30 min of each NIV session), a sensory deprivation group (where they wore insulating headphones and were subjected to visual deprivation during the first 30 min of each NIV session), or a control group (where they received NIV as routinely performed). The primary outcome was the change in respiratory discomfort before and after 30 min of the first NIV session.A total of 113 patients were randomised (36 in the musical intervention group, 38 in the sensory deprivation group and 39 in the control group). Median (interquartile range (IQR)) change in respiratory discomfort was 0 (−1; 1) between the musical intervention and control groups (p=0.7). Between groups comparison did not evidence any significant variation of respiratory parameters across time or health-related quality of life (HRQoL) at day-90. The Peri-traumatic Distress Inventory (PDI) at intensive care unit (ICU) discharge was reduced in musical intervention group patients. However, a 30 min musical intervention did not reduce respiratory discomfort during NIV for ARF in comparison to conventional care or sensory deprivation.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Development and evaluation of an online medication safety module for medical students at a rural teaching hospital: the Winchester District Memorial Hospital

BMJ Open Quality ◽

10.1136/bmjoq-2021-001385 ◽

2021 ◽

Vol 10 (2) ◽

pp. e001385

Author(s):

Ali Elbeddini ◽

Yasamin Tayefehchamani

Keyword(s):

Online Learning ◽

Medical Students ◽

Medication Safety ◽

Controlled Trial ◽

Effective Means ◽

Intervention Group ◽

Control Group ◽

Open Label ◽

Online Module ◽

Learning Module

ObjectiveTo design, implement and assess an online learning module for third-year and fourth-year medical students addressing medication safety.DesignThis study was a prospective, parallel, open-label, randomised controlled trial with two arms: (1) a control arm in which students were given five articles to read about medication safety, and (2) an intervention arm in which students were given access to an interactive web-based learning module on medication safety. Pretesting and post-testing were done online to evaluate change in medication safety knowledge.ResultsTen students completed the study in the intervention group (online module) and six students completed the study in the control group. The increase in score obtained on the post-test, relative to the pretest, was 15.4% in the group who completed the online module and 2.0% in the control group (difference=13.4%, 95% CI 0.5% to 26.2%, p=0.04).ConclusionStudents who completed an online educational tool about medication safety demonstrated a significantly greater increase in knowledge than those who completed a few readings. Online learning modules can be a convenient and effective means of teaching safe prescribing concepts to medical trainees.

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Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/9329465 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8

Author(s):

Yu-yang Pang ◽

Yan Li ◽

Gang Kui ◽

Yong Tang ◽

Ming-juan Liao ◽

...

Keyword(s):

Clinical Trial ◽

Myeloproliferative Neoplasms ◽

Controlled Trial ◽

Intervention Group ◽

Complete Healing ◽

Control Group ◽

Controlled Clinical Trial ◽

Leg Ulcers ◽

Open Label ◽

Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

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Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽

10.1136/bmjopen-2018-024589 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024589

Author(s):

Wen Yao Mak ◽

Loke Meng Ong ◽

Bak Leong Goh ◽

Sunita Bavanandan ◽

Lily Mushahar ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Open Label ◽

Randomised Controlled ◽

End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

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A randomised controlled trial to evaluate a medication monitoring system for TB treatment

The International Journal of Tuberculosis and Lung Disease ◽

10.5588/ijtld.21.0373 ◽

2022 ◽

Vol 26 (1) ◽

pp. 44-49

Author(s):

J. Acosta ◽

P. Flores ◽

M. Alarcón ◽

M. Grande-Ortiz ◽

L. Moreno-Exebio ◽

...

Keyword(s):

Controlled Trial ◽

Treatment Success ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Second Phase ◽

Open Label ◽

Pulmonary Tb ◽

Tb Treatment ◽

Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

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Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04747-8 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mehdi Hassaniazad ◽

Ali Bazram ◽

Soheil Hassanipour ◽

Mohammad Fathalipour

Keyword(s):

Interferon Beta ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

List Type ◽

Peptic Ulcers ◽

Efficacy And Safety ◽

Open Label ◽

Full Protocol ◽

Bandar Abbas

Abstract Objectives We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria: Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. Hospitalized ≤ 48 h. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. Exclusion criteria: Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. Severe and critical COVID-19 pneumonia. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. Pregnancy and breastfeeding. Intervention and comparator Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day. Control group: lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups. Main outcomes The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O2 saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization. Randomization Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group). Trial status The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020. Trial registration Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3. Registered on 22 July 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

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Diets enriched with whole grains reduce premenstrual syndrome scores in nurses: an open-label parallel randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114519000333 ◽

2019 ◽

Vol 121 (09) ◽

pp. 992-1001 ◽

Cited By ~ 1

Author(s):

Mozhgan Esmaeilpour ◽

Sedigheh Ghasemian ◽

Mohammad Alizadeh

Keyword(s):

Clinical Trial ◽

Premenstrual Syndrome ◽

Controlled Trial ◽

Intervention Group ◽

Whole Grains ◽

Control Group ◽

Controlled Clinical Trial ◽

Daily Consumption ◽

Open Label ◽

Refined Grains

AbstractAlthough previous studies have demonstrated the beneficial effects of some components of whole grains on premenstrual syndrome (PMS), our literature review shows that no clinical trial has studied the effect of whole grain consumption on PMS so far. Therefore, the present study was designed to study the effect of diets rich in whole grains on PMS among nurses. This study is a parallel controlled clinical trial with a 3-month intervention period in which, after following two menstrual cycles among nurses, 100 nurses diagnosed with PMS were randomly divided into two groups of intervention and control, with fifty individuals in each. Those in the intervention group replaced at least four servings of refined grains in their daily diets with whole grains. To supply four servings, 120 g of bread made with whole flour was given to the intervention group on a daily basis. Those in the control group, however, continued their regular daily consumption of grains. The two groups were compared regarding PMS symptoms after adjusting the confounding variables. The repeated measurement test showed that the interaction between the time factor and the experimental group on the mean score of PMS symptoms was significant. That is, the intervention group showed a significant decrease in the general, mood, physical and behavioural symptoms of PMS compared with the controls (P<0·001, P=0·01, P<0·001 and P=0·003, respectively). Therefore, daily consumption of whole grains in place of refined grains can contribute to improvement in PMS symptoms. Further studies are needed to confirm our findings.

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Evaluation of a Multi-disciplinary Medical Model in Vancomycin Treatment in Chinese Adult Patients: A Randomized Controlled Trial

10.21203/rs.3.rs-30816/v1 ◽

2020 ◽

Author(s):

Lingyun Ma ◽

Ying Zhou ◽

Chaoyang Chen ◽

Feifei Gao ◽

Xueying Li ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Medical Model ◽

Kidney Injury ◽

Outcome Analysis ◽

Control Group ◽

Large Sample Size ◽

Open Label ◽

Mortality And Morbidity ◽

Chinese Adult

Abstract Background Acute kidney injury (AKI) is a common adverse drug reaction of vancomycin which is associated with increased mortality and morbidity. To investigate the roles of a multi-disciplinary medical model in preventing vancomycin-induced AKI (VI-AKI) through a standardized clinical path. Methods This study was a single center open-label randomized clinical trial which included adult pneumonia patients using vancomycin in Peking University First Hospital. In the intervention group (multi-disciplinary medical model), a standardized clinical path was conducted as (1) pharmacists-driven PopPK formula-based vancomycin regimen. (2) pharmacists-driven TDM monitor. (3) physicians-driven SCr monitor. (4) nephrologists-driven multi-disciplinary kidney protection. Pharmacists or nephrologists did not intervene patients; treatment in the control group (routine medical model). The primary outcome was the incidence of VI-AKI. Results145 patients including 72 in the intervention arm and 73 in the control arm, aged 69.0 (60.0-79.0) years with male in 74.5%, were included in the outcome analysis. The incidence of AKI was 23.6% (17/72) in the intervention arm and 34.2% (25/73) in the control arm (P=0.16). Among the 57 patients in the intervention arm who accepted PopPK based vancomycin regimen, AKI incidence was significantly decreased compared to patients in the control arm (15.8% vs. 34.2%, P=0.02). Conclusions Intervention with a multi-disciplinary medical model through standardized clinical path has the potential to reduce the incidence of VI-AKI. Multicenter and large sample size studies are warranted. This trial is registered with chictr.org (number ChiCTR1900021115, http://www.chictr.org.cn/edit.aspx?pid=35376&htm=4) on 29th Jan 2019 by retrospective registration.

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Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph181910328 ◽

2021 ◽

Vol 18 (19) ◽

pp. 10328

Author(s):

Filomena Pietrantonio ◽

Antonio Vinci ◽

Francesco Rosiello ◽

Elena Alessi ◽

Matteo Pascucci ◽

...

Keyword(s):

Internal Medicine ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Severity Index ◽

Control Group ◽

Portable Devices ◽

Open Label ◽

Post Discharge ◽

Major Complications

Background: Wireless vital parameter continuous monitoring (WVPCM) after discharge is compared to regular monitoring to provide data on the clinical-economic impact of complex patients (CPs) discharged from Internal Medicine Units of Ospedale dei Castelli, Lazio. Primary outcome: Major complications (MC) reduction. Secondary outcomes: Patients who reached discharge criteria within the 7th day from admission; difference in MC incidence at the conclusion of the standard telemonitoring/clinical monitoring phase, 5 and 30 days after discharge; and conditions predisposing to MC occurrence. Methods: Open label randomized controlled trial with wearable wireless system that creates alerts on portable devices. Continuous glycemic monitoring is performed for patients with diabetes mellitus. Results: There were 110 patients enrolled (mean age: 76.2 years). Comorbidity: Cumulative Illness Rating Scale CIRS-CI (comorbidities index): 3.93, CIRS SI (severity index): 1.93. About 19% scored a BRASS (Blaylock Risk Assessment Screening Score) ≥20 indicating need for discharge planning requiring step-down care. Globally, 48% of patients in the control group had major complications (27 out of 56 patients), in contrast to 22% in the intervention group (12 out of 54 patients). Conclusions: Since WVPCM detects early complications during the post-discharge CPs monitoring, it increases safety and reduces inappropriate access to the Emergency Room, preventing avoidable re-hospitalizations.

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N-Chromosome Royal Jelly, Propolis and Bee Pollen Supplementation Improve the Clinical Conditions of COVID-19 Patients: A Randomized Controlled Trial

Traditional and Integrative Medicine ◽

10.18502/tim.v6i4.8269 ◽

2022 ◽

Author(s):

Atefeh Abedini ◽

Shadi Shafaghi ◽

Zahra Ameri Ahmad ◽

Elmira Javanmardi ◽

Fariba Ghorbani ◽

...

Keyword(s):

Royal Jelly ◽

Controlled Trial ◽

Intervention Group ◽

Antimicrobial Activities ◽

Functional Class ◽

The Body ◽

Control Group ◽

Open Label ◽

Virus Propagation ◽

Bee Pollen

Royal jelly, propolis, and bee pollen are used for different purposes all around the world according to their anti-inflammatory, antioxidant, and antimicrobial activities. Given that Coronavirus 2019 (COVID-19) is a viral condition accompanied by a dysregulated inflammatory response in the body, we intend to evaluate the effects of natural supplementations on the disease course. A randomized, open-label, controlled trial was conducted among 50 definitive cases of COVID-19. These patients were randomly assigned into control and intervention groups. Royal Jelly, propolis, and bee pollen were prescribed to patients in the intervention group (n = 24) in addition to conventional treatment; while the control group only received the standard treatment (n = 26). At the end of the study, functional class improved in both groups, but this change was more pronounced in the intervention group (p < 0.05). Moreover, total symptoms duration and the time to return to work were significantly reduced in the intervention group (p < 0.05). Although royal jelly, propolis, and bee pollen are not definitive treatments in COVID-19 patients, they can be used as an adjuvant treatment to limit disease symptoms and virus propagation.

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