Randomized Controlled Pilot Study of Video Self-assessment for Resident Mastoidectomy Training

A prospective randomized controlled pilot study was performed to determine if video self-assessment improves competency in mastoidectomy and to assess interrater agreement between expert and resident evaluations of recorded mastoidectomy. Sixteen otolaryngology residents were recorded while performing cadaveric mastoidectomy and randomized into video self-assessment and control groups. All residents performed a second recorded mastoidectomy. Performance was evaluated by blinded experts with a validated assessment scale. Video self-assessment did not lead to greater skill improvement between the first and second mastoidectomy. Interrater agreement was fair to substantial between the expert evaluators and between resident self-evaluations by recall and video review. Agreement between experts and residents was only slight to fair; residents consistently rated their performance higher than experts ( P < .05). In conclusion, 1 session of video self-review did not lead to improved competence in mastoidectomy over standard practice. While experts agree on assessments, residents may overestimate their competency in performing cadaveric mastoidectomy.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽

10.3390/metabo11040204 ◽

2021 ◽

Vol 11 (4) ◽

pp. 204

Author(s):

Anissa Aharaz ◽

Jens Henning Rasmussen ◽

Helle Bach Ølgaard McNulty ◽

Arne Cyron ◽

Pia Keinicke Fabricius ◽

...

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Inappropriate Medication ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Patient Interviews ◽

Number Of Patients ◽

Multimorbid Patients ◽

And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

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Immersive Virtual Reality Improves Labor and Delivery Experience for Women: A Randomized Controlled Trial

10.21203/rs.3.rs-898920/v1 ◽

2021 ◽

Author(s):

Elif Gizem Carus ◽

Nazli Albayrak ◽

Selen Gur Ozmen ◽

Halit Mert Bildirici

Keyword(s):

Virtual Reality ◽

Patient Satisfaction ◽

Rating Scale ◽

Secondary Outcome ◽

Immersive Virtual Reality ◽

Labor And Delivery ◽

Control Groups ◽

Randomized Controlled ◽

Pain Scores ◽

And Control

Abstract Objective: To evaluate the effectiveness of immersive Virtual Reality (VR) in laboring women on patient satisfaction as a distractive tool and pain relief.Methods: Randomized, controlled clinical trial with 42 laboring women allocated to VR intervention and control groups. Among the VR group, patient satisfaction with the use of VR was assessed by a Virtual Reality Satisfaction Survey and questioning whether they would choose VR in future labor. As a primary outcome patient satisfaction scores regarding the overall labor and delivery experience were compared between the two groups. A secondary outcome was pain assessed by a visual pain rating scale in the early and active phases of labor in both groups. Psychometric information was also collected from participants in each group using Beck Anxiety Inventory and Beck Depression Inventory. Results: We observed a high level of patient satisfaction with the use of immersive VR during labor. The survey revealed a mean satisfaction score of 89.6 ± 10.8 out of a maximum of 100. 20 out of 21 (95%) women in the VR group stated that they would like to use VR again in future labor. VR improved pain scores in early labor and contributed positively to overall labor and delivery experience. The mean pain score pre-VR was 2.6±1.2 compared to 2.0±1.3, post-VR, respectively (p<0.01). Anxiety and depression scores were similar in the intervention and control groups (p=0.103, p=0.13, respectively). Conclusion: Immersive VR application during labor was feasible and associated with higher patient satisfaction based on our study. VR also improved pain scores in early labor before epidural placement. Immersive VR may find a place as an adjunct in Labor and Delivery Units to improve the lengthy labor experience for women. Larger studies are needed to confirm these observations. Trial Registration: ClinicalTrials.gov: NCT05032456 / 02/09/2021https://clinicaltrials.gov/ct2/show/NCT05032456

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The Effectiveness of Auditory Stimuli from Murottal Quran to Improve Comfort and Weight in Low Birth Weight Infants: Randomized Controlled Trial

Jurnal NERS ◽

10.20473/jn.v13i2.14823 ◽

2019 ◽

Vol 14 (1) ◽

pp. 111

Author(s):

Desriati Devi ◽

Yeni Rustina ◽

Defi Efendi

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Low Birth Weight ◽

Controlled Trial ◽

Auditory Stimuli ◽

Control Groups ◽

Low Birth Weight Infants ◽

Randomized Controlled ◽

Significant Difference ◽

And Control

Introduction: Low birth weight (LBW) infants who have been hospitalized are exposed to various conditions that provoke discomfort, which could trigger a stress response and growth disorders. This study aimed to identify the effects of auditory stimuli from Murottal Quran when it comes to the comfort and weight of LBW infants.Methods: This study used a clinical randomized controlled trial design involving 52 low birth weight infants. The infants were randomly assigned to either the intervention group (n=26) or the control (n=26). The intervention of Murottal Quran was given using a speaker 4 times a day for 20 minutes every 3 hours. This intervention was conducted for three days.Results: The results of this study show that there is a significant difference in the comfort of low birth weight infants after Murottal Qur’an on the first, second, and third days between the intervention and control groups (p=0.014; <0.001; <0.001). There was no significant difference in the weight between the intervention and control groups in the first, second, and third days (p=0.481; 0.481; 0.464).Conclusion: The auditory stimuli of Murottal Quran can help to improve the comfort level of low birth weight infants during hospitalization. It can therefore be used as a supportive therapy to facilitate low birth weight infant and premature infant development.

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The Effectiveness of Tocilizumab in the Treatment of COVID-19 in Adults: A Meta-Analysis of Randomized Controlled Trials.

10.21203/rs.3.rs-551091/v1 ◽

2021 ◽

Author(s):

Chun Chen ◽

ZeMei Zhou ◽

Jing Zhang

Keyword(s):

Randomized Controlled Trials ◽

Hospital Discharge ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Composite Outcome ◽

Control Groups ◽

Randomized Controlled ◽

Serious Infection ◽

And Control

Abstract Background: Since December 2019, COVID-19 has spread to the world which leads to a global health threat. We aimed to investigate the effectiveness of tocilizumab on COVID-19 patients.Methods: We systematically searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and WHO international Clinical Trials Registry Platform (ICTRP) from their inception to March 10, 2021 for randomized controlled trials (RCTs) on tocilizumab supplementation in adults with COVID-19 disease. The primary outcomes were mortality at 28-30 day and 60-day, incidence of mechanical ventilation (MV), composite outcome of death or MV, time to hospital discharge, and intensive care unit (ICU) admissions. A random-effects meta-analysis model was used to pool studies. Results: Eleven studies with a total of 6,579 patients were included in our meta-analysis, of which 3,406 and 3,173 were respectively assigned to the tocilizumab and control groups. Tocilizumab could significantly reduce 28-30 day mortality (RR = 0.89, 95% CI 0.80-0.99, P = 0.04), incidence of MV (RR= 0.79, 95% CI 0.71-0.89, P = 0.0001), composition outcome of MV or death (RR = 0.81, 95% CI 0.72-0.90, P = 0.0002), time to hospital discharge (HR = 1.30, 95% CI 1.16-1.45, P ＜ 0.00001 ), ICU admissions (RR = 0.64, 95% CI 0.47-0.88, P = 0.006), serious infection (RR = 0.61, 95% CI 0.40-0.94, P = 0.02) and events of serious adverse advents (RR = 0.64, 95% CI 0.47-0.86, P = 0.004). There was no significant difference between tocilizumab and control groups in 60-day mortality and adverse events (AEs).Conclusions: Tocilizumab could reduce the short-term mortality, incidence of MV, composite outcome of death or MV, ICU admissions, serious infection and events of serious adverse advents, and shorten the time to hospital discharge in hospitalized patients with COVID-19. The optimal effective dose needs to be confirmed by further studies.

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A randomized controlled trial of combination of peppermint, lavender, and turmeric oil for antipruritic agent in pregnant women

Medical Journal of Indonesia ◽

10.13181/mji.oa.204467 ◽

2021 ◽

Vol 30 (1) ◽

pp. 39-44

Author(s):

Fransisca Retno Asih ◽

Farid Husin ◽

Oki Suwarsa ◽

Irda Fidrianny ◽

Dany Hilmanto

Keyword(s):

Pregnant Women ◽

Controlled Trial ◽

Control Groups ◽

Analog Scale ◽

Chi Square ◽

Herbal Products ◽

Randomized Controlled ◽

Level I ◽

And Control ◽

Single Blind

BACKGROUND Pruritus is the most common dermatological complaint that occurs during pregnancy, which is around 14–20%. No research related to herbal products to reduce some of the characteristics of pruritus at once has been conducted. This study aimed to assess the effect of blending oil to reduce pruritus based on visual analog scale (VAS). METHODS This was a single-blind, randomized clinical trial that included 57 pregnant women who were at 25–38 weeks of gestation, had a pruritus during pregnancy, a single pregnancy, a level I and II pruritus and a moderate to severe pruritus based on VAS. Pruritus scores were measured using VAS in both the treatment and control groups. The treatment and control groups applied blending oil and placebo, respectively, twice a day after bathing for 2 weeks. Mann–Whitney U, paired t, and chi-square tests were used for the analysis. RESULTS Pruritus reduction in pregnant women who received blending oil was higher than those using placebo (61.08% versus 12.41%, p<0.05). 83% of subjects using blending oils had a reduction of pruritus by >25 mm. Pregnant women who used placebo had a six times greater risk of experiencing pruritus than those who used blending oil (RR = 5.8, 95% CI = 2.613–12.874). CONCLUSIONS Blending oil can be used topically to treat a pruritus in pregnant women.

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Auditory and Visual Executive Functions in Children and Response to Methylphenidate: A Randomized Controlled Trial

Journal of Attention Disorders ◽

10.1177/1087054717700978 ◽

2017 ◽

Vol 24 (2) ◽

pp. 235-245

Author(s):

Yaffa Hadar ◽

Shraga Hocherman ◽

Oren Lamm ◽

Emanuel Tirosh

Keyword(s):

Executive Functions ◽

Visual Cues ◽

Controlled Trial ◽

Crossover Design ◽

Control Groups ◽

Children With Adhd ◽

Randomized Controlled ◽

The Difference ◽

Visually Based ◽

And Control

Objectives: The aim of the study was to assess auditory and visually based executive functions (EFs) and the effect of methylphenidate (MPH) in children with ADHD. Methods: Thirty-six boys between the ages of 8.3 and 9.7 years with ADHD and 36 matched controls were included. The study group was randomized into MPH and placebo for 7 days each in a crossover design. A Cued Choice Reaction Time (CCRT) test that included incongruent cuing was administered at baseline and following 1 and 2 weeks. Results: The difference between the study and control groups was more evident with visual cues and incongruent cuing. Increased gains by children with predominantly hyperactive–impulsive\combined (HI\C) type of ADHD were observed under MPH. Conclusions: The differences between children with ADHD and typical children are more pronounce under incongruent auditory cuing . The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.

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Abstract 2211: Statin Therapy May Increase the Risk of Intracerebral Hemorrhage: A Meta-analysis of 26 Randomized Controlled Trials

Stroke ◽

10.1161/str.43.suppl_1.a2211 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

James S McKinney ◽

William J Kostis ◽

John B Kostis

Keyword(s):

Statin Therapy ◽

Meta Analysis ◽

Active Group ◽

Controlled Trials ◽

Control Groups ◽

Randomized Controlled ◽

All Cause Mortality ◽

Group A ◽

The Difference ◽

And Control

Introduction--- Statin therapy decreases the risk of myocardial infarction and ischemic stroke. However, an increased risk of intracerebral hemorrhage (ICH) has been observed in some studies. To investigate this issue we performed a meta-analysis of all randomized controlled trials (RCTs) using statins that reported ICH. Methods--- We performed a Medline literature search through March 18, 2011 and identified additional RCTs by reviewing reference lists of retrieved studies and prior meta-analyses. All RCTs of statin therapy versus placebo or high dose versus low dose statin therapy that reported ICH or hemorrhagic stroke were included. The primary outcome variable was ICH. 26 RCTs were included. All analyses used random effects models and heterogeneity was not observed in any of the analyses. Results--- 84 831 subjects were included in the Active group, and 84 851 in the Control group. A trend towards a higher incidence of ICH was observed in the Active treatment group compared to Control (OR = 1.15; 95% CI = 0.91 to 1.45, p =0.24) (Figure). Significant relationships were not observed between the log OR for ICH with achieved LDL in the Active group (slope = 0.0002; 95% CI = -0.0098 to 0.0101, p =0.96) or with the difference in LDL drop between the Active and Control groups (slope = 0.0030; 95% CI = -0.0089 to 0.0149, p =0.62). Total stroke (OR = 0.84; 95% CI = 0.78 to 0.91, p <0.001) and all-cause mortality (OR = 0.91; 95% CI = 0.86 to 0.96, p <0.001) were significantly reduced in the Active group. A significant relationship between all-cause mortality and the difference in LDL drop between the Active and Control groups was observed (slope = -0.0030; 95% CI = -0.0009 to -0.0051, p<0.005). There was not evidence of publication bias in this meta-analysis. Conclusions--- Active therapy was associated with a trend towards increased ICH in this meta-analysis of 26 RCTs of statin therapy. However, this risk does not appear to be related to the degree of decline or achieved LDL. The risk of ICH is offset by a significant reduction in ischemic stroke and all-cause mortality and should not dissuade practitioners from prescribing statins in otherwise appropriate patients.

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Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

Clinical Rehabilitation ◽

10.1177/02692155211041104 ◽

2021 ◽

pp. 026921552110411

Author(s):

Hiromichi Takeda ◽

Katsuhiko Takatori

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Adherence ◽

Control Group ◽

Adult Day Care ◽

Control Groups ◽

Randomized Controlled ◽

And Control ◽

Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

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Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215512450521 ◽

2012 ◽

Vol 27 (2) ◽

pp. 133-141 ◽

Cited By ~ 27

Author(s):

Venkatesan Prem ◽

Ramesh Chandra Sahoo ◽

Prabha Adhikari

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Control Groups ◽

Quality Of Life Questionnaire ◽

Randomized Controlled ◽

Questionnaire Score ◽

And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

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