Hemodynamic Differences Between Basilar Artery Fenestration and Normal Vertebrobasilar Artery: A Pilot Study

Background: Basilar artery fenestration has been proposed as a contributor to ischemic stroke, as unique flow patterns induced by fenestration may be related to thrombus formation or insufficiency. This study aimed to evaluate the hemodynamics of basilar artery fenestration (BAF) using computational fluid dynamics (CFD).Methods: Patients with BAF and normal vertebrobasilar system were recruited and separately evaluated using CFD. Specific geometric vascular models were reconstructed based on 3D-rotational angiography (3D-RA). Patients were divided into the BAF group and control group (i.e., patients with the normal vertebrobasilar system). Hemodynamic and geometric variables were calculated and compared between groups using Student's t-test or Wilcoxon rank-sum test.Results: Overall, 24 patients were included, with 12 patients each in the BAF group and the control group. The BAF group had a significantly smaller basilar artery diameter than the control group (3.1 ± 0.51 vs. 3.76 ± 0.4, p = 0.002). Compared to the control group, the BAF group had higher values of maxOSI (median, 0.3 vs. 0.09, p = 0.028), TAWSSG (median, 983.42 vs. 565.39, p = 0.038) in the flow confluence, higher SAR-TAWSSG in bifurcation (median, 70.22 vs. 27.65, p = 0.002) and higher SAR-TAWSSG in basilar artery (median, 48.75 vs. 16.17, p < 0.001) of the vertebrobasilar artery.Conclusions: This pilot study suggested that hemodynamic differences between BAF and normal vertebrobasilar artery across multiple shear flow parameters. The disturbed flow in the BAF may increase the risk of thrombus formation, plaque instability, and subsequent ischemic cerebrovascular events. These should be confirmed by future studies.

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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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Treatment Success and User-Friendliness of An Electric Toothbrush App: A Pilot Study

Dentistry Journal ◽

10.3390/dj8030097 ◽

2020 ◽

Vol 8 (3) ◽

pp. 97

Author(s):

Viviane Humm ◽

Daniel Wiedemeier ◽

Thomas Attin ◽

Patrick Schmidlin ◽

Stefanie Gartenmann

Keyword(s):

Pilot Study ◽

Treatment Success ◽

Test Group ◽

Plaque Index ◽

Control Group ◽

Controlled Clinical Trial ◽

User Friendliness ◽

Short Period ◽

Electric Toothbrush ◽

And Control

Electronic and mobile health (eHealth/mHealth) are rapidly growing areas in medicine and digital technologies are gaining importance. In dentistry, digitalization is also an emerging topic, whereby more and more applications are being offered. As an example, using real-time feedback, digital application software (an app) was designed to help users brush their teeth more accurately. However, there is no data on the effectiveness and haptic of such apps. Therefore, a single-blinded, randomized controlled clinical trial was designed: twenty volunteers received an electric toothbrush with an associated app to assess whether the app-assisted toothbrushing is better than without. After a short period of familiarization with the electric toothbrush, plaque index (O‘Leary et al. 1972) was recorded and subjects were assigned to the test (with app; n = 10) or the control group (no app; n = 10). At the end of the 2-week pilot study period, plaque was again assessed and participants in the test group completed a questionnaire about the app’s user-friendliness. Statistical analysis revealed no significant differences between the test and control groups. The plaque index improved on average by 8.5% points in the test and 4.7% points in the control group. Fifty percent of the test group participants were of the opinion that they had achieved better cleaning results and would recommend the app to others, although the app contributed only marginally to increased plaque removal. However, such apps may nevertheless be helpful as motivational tools, especially when tracking and monitoring cleaning data. Therefore, more development and research on this topic is indicated.

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C – reactive protein in saliva of non-smoking patients with periodontitis (a pilot study)

Journal of Health Sciences ◽

10.17532/jhsci.2021.1327 ◽

2021 ◽

Author(s):

Zerina Hadžić ◽

Ivan Puhar

Keyword(s):

Pilot Study ◽

Test Group ◽

Periodontal Therapy ◽

Control Group ◽

C Reactive Protein ◽

Inflammatory Biomarker ◽

Reactive Protein ◽

Before And After ◽

Oral Hygiene Instructions ◽

And Control

Introduction: C-reactive Protein (CRP) as an inflammatory biomarker can be easily determined in saliva, but the values of salivary CRP in periodontitis are not well-studied. The aim of this study was to analyze and determine the values of salivary CRP in non-smokers with periodontitis stage 3 or 4 before and after supragingival and subgingival full-mouth periodontal therapy.Methods: Standard periodontal parameters and saliva samples were collected in 12 non-smoking patients. Patients in the test group (n = 6) underwent supragingival and subgingival full-mouth periodontal therapy, and the control group (n = 6) received only supragingival full-mouth therapy. Both groups received the same oral hygiene instructions in addition to therapy. After 3 months, re-registration of periodontal parameters and re-sampling of saliva for analysis of salivary CRP were done for both groups.Results: Statistical analysis revealed large differences in the values of clinical periodontal parameters and CRP levels in the test group after therapy. Values of salivary CRP in the test and control groups were lower 3 months the therapy; however, the results were not statistically significant. The correlation of clinical periodontal parameters and salivary CRP varied in both groups.Conclusion: Our pilot study reveals decreased concentrations of salivary C-reactive protein in non-smoking patients following non-surgical periodontal therapy. Further studies are needed to prove the reliability of salivary CRP as a biomarker for periodontitis.

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Association of Fungi and Archaea of the Gut Microbiota with Crohn’s Disease in Pediatric Patients—Pilot Study

Pathogens ◽

10.3390/pathogens10091119 ◽

2021 ◽

Vol 10 (9) ◽

pp. 1119

Author(s):

Agnieszka Krawczyk ◽

Dominika Salamon ◽

Kinga Kowalska-Duplaga ◽

Tomasz Bogiel ◽

Tomasz Gosiewski

Keyword(s):

Crohn’S Disease ◽

Pilot Study ◽

Crohn's Disease ◽

Pediatric Patients ◽

Control Group ◽

Healthy Controls ◽

Stool Samples ◽

Malassezia Spp ◽

And Control ◽

To Receive

The composition of bacteria is often altered in Crohn’s disease (CD), but its connection to the disease is not fully understood. Gut archaea and fungi have recently been suggested to play a role as well. In our study, the presence and number of selected species of fungi and archaea in pediatric patients with CD and healthy controls were evaluated. Stool samples were collected from children with active CD (n = 54), non-active CD (n = 37) and control subjects (n = 33). The prevalence and the number of selected microorganisms were assessed by real-time PCR. The prevalence of Candida tropicalis was significantly increased in active CD compared to non-active CD and the control group (p = 0.011 and p = 0.036, respectively). The number of Malassezia spp. cells was significantly lower in patients with active CD compared to the control group, but in non-active CD, a significant increase was observed (p = 0.005 and p = 0.020, respectively). There were no statistically significant differences in the colonization by archaea. The obtained results indicate possible correlations with the course of the CD; however, further studies of the entire archeobiome and the mycobiome are necessary in order to receive a complete picture.

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Use of Mustard Seed Footbaths for Respiratory Tract Infections: A Pilot Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/5648560 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6

Author(s):

Katja Goetz ◽

Aune Hinz ◽

Jost Steinhäuser ◽

Ulrich von Rath

Keyword(s):

Pilot Study ◽

Respiratory Tract ◽

Respiratory Tract Infections ◽

Intervention Group ◽

Repeated Measurements ◽

Mustard Seed ◽

Control Group ◽

Subjective Perception ◽

Tract Infections ◽

And Control

Objective. Respiratory tract infections (RTIs) are the most commonly treated acute problems in general practice. Instead of treatment with antibiotics, therapies from the field of integrative medicine play an increasingly important role within the society. The aim of the study was to evaluate whether mustard footbaths improve the symptoms of patients with RTIs. Methods. The study was designed as a pilot study and was carried out as an interventional trial with two points of measurement. Between November and December 2017, six practices were invited to participate. Two of them participated in the study. Patients were included who presented with an RTI at one of the involved primary care practices during February and April 2018. Participants in the intervention group used self-administered mustard seed powder footbaths at home once a day, to be repeated for six consecutive days. The improvement of symptoms was measured using the “Herdecke Warmth Perception Questionnaire” (HeWEF). A variance analysis for repeated measurements was performed to analyse differences between the intervention and control groups. Results. In this pilot study, 103 patients were included in the intervention group and 36 patients were included in the control group. A comparison of the intervention and control group before the intervention started showed nearly no difference in their subjective perception of warmth measured by the HeWEF questionnaire. Participants of the intervention group who used mustard seed footbaths for six consecutive days showed an improvement in four of the five subscales of the HeWEF questionnaire. Conclusions. This study could provide a first insight into a possible strategy to improve symptoms regarding RTI by using mustard seed footbaths.

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Contributions of auriculotherapy in smoking cessation: a pilot study

Revista da Escola de Enfermagem da USP ◽

10.1590/s0080-6234201400005000015 ◽

2014 ◽

Vol 48 (5) ◽

pp. 883-890

Author(s):

Roberta de Paiva Silva ◽

Erika de Cássia Lopes Chaves ◽

Sandra Cristina Pillon ◽

Andréia Maria Silva ◽

Denis da Silva Moreira ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Pilot Study ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Future Studies ◽

Randomized Controlled ◽

And Control ◽

Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

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Effectiveness of Exercises in Glycaemic Control and Maternal Outcome among Women with Gestational Diabetes Mellitus- A Pilot study

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/46594.14924 ◽

2021 ◽

Author(s):

Reena Wilma Frank ◽

Kaipangala Raja Gopal ◽

Devina E Rodrigues

Keyword(s):

Diabetes Mellitus ◽

Pilot Study ◽

Intervention Group ◽

Maternal Outcome ◽

Control Group ◽

P Value ◽

Significant Difference ◽

Moderate Effect ◽

And Control ◽

Interventional Group

Introduction: Diabetes Mellitus is a common medical problem that is very often seen in pregnancy in the present era. Pregnant women should keep in mind their health and lifestyle considerations or else pregnancy will end up with many complications. Pre-existing factors and pregnancy factors will be contributing and make pregnancy more complicated. Exercises are recommended as a healthy practice which prevents many diseases and provides a healthy life. Aim: To evaluate the glycaemic level by focusing on exercises to improve the maternal outcome. Materials and Methods: A Pilot study with Quasi-experimental pre-post control group design with 30 Gestational Diabetes Mellitus (GDM) women (15 in each group) were selected who met the inclusion and exclusion criteria. The study was conducted in tertiary care Hospital between June 2019 and December 2019. Based on the convenience sampling technique, the setting was selected and a simple random technique was adopted to select the subjects. The 15 subjects were included in each groups, both intervention and control group. Exercises were taught for the interventional group of women for 12 weeks. Regular treatment was continued for both groups which include medication, diet and regular walking. Pre-test and post-test glycaemic scores were done for both the groups. Mann-whitney test, ANOVA, post-hoc test, paired Eta square were also used and IBM Statistical Package for the Social Sciences (SPSS) version 23.0 was used. Results: The study shows there was a significant difference in the pre-Fasting Blood Sugar (FBS) and post FBS values in the intervention group p-value <0.027. The paired Eta square value was 0.303 which showed a moderate effect of the exercise on the glycaemic value in the interventional group. There was a significant difference in the pre glycosylated haemoglobin (HbA1c) and post HbA1c values in both the intervention and control group was p-value <0.023 and p-value <0.025, respectively. The maternal outcome shows increased severity of the complications in the control group while comparing with the intervention group such as pre-eclampsia, operative interference, and preterm deliveries. But there was no significant difference in the maternal outcome observed between intervention and control group p-value >0.05. Conclusion: Regular moderate-intensity aerobic and resistance exercise training during pregnancy is associated with lower blood glucose level. Thus, study concluded that exercise has a moderate effect on glycaemic control.

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A Retrospective Study of Parent’s First-Hand Experience of Premonitions and Other Anomalous Aspects of the SIDS Phenomenon: A potential “SIDS early warning system?”

Neonatology Today ◽

10.51362/neonatology.today/2021716738 ◽

2021 ◽

Vol 16 (7) ◽

pp. 3-8

Author(s):

Eric Sage ◽

Nancy Maruyama ◽

Joseph Hageman

Keyword(s):

Pilot Study ◽

Early Warning ◽

Infant Death ◽

Early Warning System ◽

Warning System ◽

Study Groups ◽

Control Group ◽

Control Parent ◽

Electronic Questionnaires ◽

And Control

Introduction The main purpose of this study is to determine the incidence of premonition in SIDS parents vs. Non-SIDS/Control Group parents and to test for a number of other anomalous "markers" noted anecdotally by decades of in the field observation. Evidence of premonition and these other "markers" as consistent elements of the SIDS phenomenon could serve as an "early warning system" for a future SIDS event if confirmed by larger studies. Methodology Both groups of SIDS parents and Control parent participants completed electronic questionnaires on the SurveyMonkey platform for statistical analysis. Results The results of this pilot study indicated statistically significant differences between the SIDS parent and Non-SIDS control study groups for premonition and a set of other anomalous markers. Conclusion The authors believe that this pilot study of premonition and other markers may provide an "early-warning" system for an impending SIDS event if confirmed with future larger studies. Importance: This pilot study confirms results of the value of premonition as well as other anomalous observations by parents whose infants may be at risk for a SIDS event. This study deserves to be confirmed by larger studies and, if so, confirmed indicates a reliable "early warning system" for an impending SIDS event. We face the problem if this SIDS event represents the small percentage of infants who will die of SIDS, even if a diagnostic evaluation and management, including hospital admission and monitoring, may not prevent death from SIDS. However, if this premonition is predictive of Sudden Unexplained Infant Death (SUID) secondary to a potentially preventable etiology, this infant death may be preventable.

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A pilot study to determine the feasibility of a cluster randomised controlled trial of an intervention to change peer attitudes towards children who stutter

South African Journal of Communication Disorders ◽

10.4102/sajcd.v65i1.583 ◽

2018 ◽

Vol 65 (1) ◽

Author(s):

Rizwana B. Mallick ◽

Lehana Thabane ◽

A.S.M. Borhan ◽

Harsha Kathard

Keyword(s):

Pilot Study ◽

Treatment Effect ◽

Dropout Rate ◽

Control Group ◽

Control Groups ◽

Post Intervention ◽

Peer Attitudes ◽

Significant Difference ◽

Randomised Controlled ◽

And Control

Background: While randomised controlled trials (RCTs) are considered the gold standard of research, prior study is needed to determine the feasibility of a future large-scale RCT study. Objectives: This pilot study, therefore, aimed to determine feasibility of an RCT by exploring: (1) procedural issues and (2) treatment effect of the Classroom Communication Resource (CCR), an intervention for changing peer attitudes towards children who stutter. Method: A pilot cluster stratified RCT design was employed whereby the recruitment took place first at school-level and then at individual level. The dropout rate was reported at baseline, 1 and 6 months post-intervention. For treatment effect, schools were the unit of randomisation and were randomised to receive either the CCR intervention administered by teachers or usual practice, using a 1:1 allocation ratio. The stuttering resource outcomes measure (SROM) measured treatment effect at baseline, 1 and 6 months post-intervention overall and within the constructs (positive social distance, social pressure and verbal interaction). Results: For school recruitment, 11 schools were invited to participate and 82% (n = 9) were recruited. Based on the school recruitment, N = 610 participants were eligible for this study while only n = 449 were recruited, where there was n = 183 in the intervention group and n = 266 in the control group. The dropout rate from recruitment to baseline was as follows: intervention, 23% (n = 34), and control, 6% (n = 15). At 1 month a dropout rate of 7% (n = 10) was noted in the intervention and 6% (n = 15) in the control group, whereas at 6 months, dropout rates of 7% (n = 10) and 17% (n = 44) were found in the intervention and control groups, respectively. For treatment effect on the SROM, the estimated mean differences between intervention and control groups were (95% Confidence Interval (CI): -1.07, 5.11) at 1 month and 3.01 (95% CI: -0.69, 6.69) at 6 months. A statistically significant difference was observed at 6 months on the VI subscale of the SROM, with 1.35 (95% CI: 0.58, 2.13). Conclusion: A high recruitment rate of schools and participants was observed with a high dropout rate of participants. Significant differences were only noted at 6 months post-intervention within one of the constructs of the SROM. These findings suggest that a future RCT study is warranted and feasible.

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