scholarly journals Electric Toy Car to Reduce Anxiety Before a Cardiac Catherization: Randomized Controlled Trial

2021 ◽  
Author(s):  
Edouard Chambon ◽  
Emmanuelle Fournier ◽  
Maha Tagorti ◽  
Florence Lecerf ◽  
Nadera Chaouche ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Anesthesia Induction ◽  
Clinical Trial Registration ◽  
Catheterization Laboratory ◽  
Electric Car ◽  
Registration Number ◽  
Males And Females ◽  
Cardiac Catherization

Abstract Anxiety before an invasive intervention is associated in children with persistent psychological disorders. We studied the effect of the transfer to the catheterization room by an electric toy-car on the anxiety of children and their parents before a cardiac catheterization. Forty-eight children with a median age of 5.6 years [4.2-7.0] were randomized to either riding on an electric car to go to the catheterization laboratory or being transported lying supine on a gurney. Anxiety assessments were performed by a physician blinded to allocation group on the day before the procedure (T0) and at anesthesia induction (T1). The modified Yale score (mYPAS-SF) and visual analog scale for anxiety (VAS-A) were used in the children, and the VAS-A in the parents. The mYPAS-SF, VAS-A-child and the VAS-A-parent scores were significantly higher at T1 than at T0 (P < 0.001, P < 0.001, and P = 0.005, respectively). The primary outcome (the median mYPAS-SF score at T1) was not significantly different in the two groups when males and females were combined. At T1, the VAS-A-child score, however, was significantly lower in the intervention than the control group (22 versus 55, P < 0.001). In the boys, the median mYPAS-SF score at T1 was significantly lower in the intervention group (25.0 versus 51.0, P = 0.024). No difference was observed in girls. The VAS-A parent score was lower at T1 in the intervention group (60 versus 87, P = 0.05). Conclusion: Riding to the catheterization laboratory on an electric toy car decreased anxiety at anesthesia induction in boys and also decreased parental anxiety.Clinical trial Registration: Registration number: ID-RCB: 2019-A00459-48. Date of registration: March 27th 2019.

scholarly journals The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial

2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Ana Cláudia Mesquita Garcia ◽  
Talita Prado Simão-Miranda ◽  
Ana Maria Pimenta Carvalho ◽  
Paula Condé Lamparelli Elias ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
State Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Physiological Variables ◽  
Randomized Controlled ◽  
Therapeutic Listening

ABSTRACT Objective: To investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Method: A randomized controlled trial with 50 patients randomly allocated in the intervention group (therapeutic listening) (n = 25) or in the control group (n = 25). The study evaluated the changes in the variables state anxiety, surgical fears and physiological variables (salivary alpha-amylase, salivary cortisol, heart rate, respiratory rate and blood pressure). Results: In the comparison of the variables in the control and intervention groups in pre- and post-intervention, differences between the two periods for the variables cortisol (p=0.043), heart rate (p=0.034) and surgical fears (p=0.030) were found in the control group, which presented reduction in the values of these variables. Conclusion: There was no reduction in the levels of the variables state anxiety and surgical fears resulting from the therapeutic listening intervention, either through the physiological or psychological indicators. However, the contact with the researcher during data collection, without stimulus to reflect on the situation, may have generated the results of the control group. Clinical Trial Registration: NCT02455128.

scholarly journals Effects of Father-Neonate Skin-to-Skin Contact on Attachment: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Er-Mei Chen ◽  
Meei-Ling Gau ◽  
Chieh-Yu Liu ◽  
Tzu-Ying Lee
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Demographic Data ◽  
Intervention Group ◽  
Active Role ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Skin Contact ◽  
Skin To Skin

This study examines how skin-to-skin contact between father and newborn affects the attachment relationship. A randomized controlled trial was conducted at a regional teaching hospital and a maternity clinic in northern Taiwan. The study recruited 83 first-time fathers aged 20 years or older. By block randomization, participants were allocated to an experimental (n=41) or a control (n=42) group. With the exception of skin-to-skin contact (SSC), participants from each group received the same standard care. Both groups also received anEarly Childcare for Fathersnursing pamphlet. During the first three days postpartum, the intervention group members were provided a daily SSC intervention with their respective infants. Each intervention session lasted at least 15 minutes in length. The outcome measure was the Father-Child Attachment Scale (FCAS). After adjusting for demographic data, the changes to the mean FCAS were found to be significantly higher in the intervention group than in the control group. We recommend that nurses and midwives use instructional leaflets and demonstrations during postpartum hospitalization, encouraging new fathers to take an active role in caring for their newborn in order to enhance father-neonate interactions and establish parental confidence. This trial is registered with clinical trial registration numberNCT02886767.

scholarly journals Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nadir Kharma ◽  
Stefan Roehrig ◽  
Ahmed Atef Shible ◽  
Moustafa Sayed Elshafei ◽  
Dema Osman ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Sample Size ◽  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Intervention Group ◽  
Sample Size Calculation ◽  
Control Group ◽  
Registration Number ◽  
Full Protocol ◽  
Allocation Ratio

Abstract Objectives To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation. Trial design This is a single centre parallel group, superiority, randomized (1:1 allocation ratio) controlled trial. Participants All patients admitted to the Hamad Medical Corporation -ICU in Qatar for COVID-19 associated respiratory distress and in need of mechanical ventilation are screened for eligibility. Inclusion criteria: all adult patients admitted to the ICU who test positive for COVID-19 by PCR-test and in need for mechanical ventilation are eligible for inclusion. Upon crossing the limit of D-dimers (1.2 mg/L) these patients are routinely treated with an increased dose of anticoagulant according to our local protocol. This will be the start of randomization. Exclusion criteria: pregnancy, allergic to the drug, inherited coagulation abnormalities, no informed consent. Intervention and comparator The intervention group will receive the anticoagulant bivalirudin intravenously with a target aPTT of 45-70 sec for three days while the control group will stay on the standard treatment with low-molecular-weight heparins /unfractionated heparin subcutaneously (see scheme in Additional file 1). All other treatment will be unchanged and left to the attending physicians. Main outcomes As a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F) ratio. Randomisation After inclusion, the patients will be randomized using a closed envelope method into the conventional treatment group, which uses the standard strategy and the experimental group which receives anticoagulation treatment with bivalirudin using an allocation ratio of 1:1. Blinding (masking) Due to logistical and safety reasons (assessment of aPTT to titrate the study drug) only the data-analyst will be blinded to the groups. Numbers to be randomised (sample size) We performed a sample size calculation and assumed the data for P/F ratio (according to literature) is normally distributed and used the mean which would be: 160 and SD is 80. We expect the treatment will improve this by 30%. In order to reach a power of 80% we would need 44 patients per group (in total 88 patients). Taking approximately 10% of dropout into account we will include 100 patients (50 in each group). Trial Status The local registration number is MRC-05-082 with the protocol version number 2. The date of approval is 18th June 2020. Recruitment started on 28th June and is expected to end in November 2020. Trial registration The protocol is registered before starting subject recruitment under the title: “Anticoagulation in patients suffering from COVID-19 disease. The ANTI-CO Trial” in ClinicalTrials.org with the registration number: NCT04445935. Registered on 24 June 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 2). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048859
Author(s):  
Fabienne El-Khoury ◽  
Tarik El Aarbaoui ◽  
Mégane Héron ◽  
Gilles Hejblum ◽  
Brigitte Métadieu ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Point Prevalence ◽  
Control Group ◽  
Socially Disadvantaged ◽  
Institutional Review ◽  
Registration Number ◽  
Sevrage Tabagique ◽  
Randomised Controlled

IntroductionMany smoking cessation aids such as nicotine replacement treatments and e-cigarettes have been proven effective in aiding smoking cessation attempts. Encouraging smokers with low socioeconomic position (SEP) to choose their smoking aid tool based on their preferences, and giving that tool free of charge, might increase the odds of smoking cessation. This trial examines the effectiveness of the ‘STOP’ (Sevrage Tabagique à l’aide d’Outils dédiés selon la Préférence: Smoking cessation using preference-based tools), a preference-based smoking cessation intervention for smokers with low SEP.Methods and analysisThe STOP study is a randomised, multicentre, controlled trial (RCT). Smokers with low SEP and wishing to quit will be randomised to either the intervention or the control group (standard care). Participants in the intervention group will be asked to choose between different types of nicotine substitutes (patches, inhalers, gum, tablets, etc) and/or an electronic cigarette which will be delivered free of charge to aid their smoking cessation attempt.The primary outcome will be smoking abstinence at 6 months after inclusion, defined as self-reported 7-day point prevalence of tobacco abstinence. Secondary outcomes include the total number of days of abstinence at 6 months after inclusion, 7-day point prevalence tobacco abstinence at 1 and 3 months after inclusion and number of relapses.The study will also include an economic evaluation, and a process evaluation using a mixed methods approach.Ethics and disseminationThe study was approved by the ‘Île de France II’ Institutional Review Board on 8 September 2020 (CPP Île de France II; Ref No: 20.01.31.65528 RIPH2 HPS), and results will be published in a peer-reviewed journal.Trial registration numberNCT04654585.

scholarly journals Effect of Capsaicin Atomization–Induced Cough on Sputum Excretion in Tracheotomized Patients After Hemorrhagic Stroke: A Randomized Controlled Trial

2021 ◽  
pp. 1-11
Author(s):  
Chao Wu ◽  
Yijie Zhang ◽  
Li Yang ◽  
Fang Shen ◽  
Chen Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hemorrhagic Stroke ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Link Type ◽  
Before And After

Background Timely and effective removal of respiratory secretions is of great significance for tracheotomized patients. The purpose of this study is to investigate the effectiveness of capsaicin nebulization to stimulate cough to promote early clearance of respiratory secretions in tracheotomized patients after hemorrhagic stroke. Method This study implemented a randomized controlled design. Sixty-three patients who were tracheotomized following a hemorrhagic stroke completed this randomized controlled trial. In the control group, 33 cases were given a routine care after tracheotomy. In the intervention group, 30 cases were given a capsaicin solution nebulization in addition to the routine care. The daily sputum output and the number of sputum suctioning were observed. The differences in sputum viscosity, cough function, and Clinical Pulmonary Infection Score (CPIS) were compared between the two groups before and after the intervention. Vital sign changes during capsaicin nebulization and suctioning were compared between the two groups in a pilot study. Results The daily sputum output of the capsaicin intervention group was significantly higher than that of the control group ( p < .05). The number of sputum suctioning of capsaicin group was less than that of the control group after intervention ( p < .05). The CPIS score of the capsaicin group was lower than that of the control group ( p < .05) after a 1-week intervention. Patients' heart rate, respiratory rate, and oxygen saturation during capsaicin nebulization were not statistically different from those during routine sputum suctioning ( p > .05). Conclusions Capsaicin atomization–induced cough can effectively promote sputum excretion of hemorrhagic stroke patients undergoing tracheotomy and has a good safety profile. The Clinical Trial registration number of this study is ChiCTR2000037772 ( http://www.chictr.org.cns ). Supplemental Material https://doi.org/10.23641/asha.16821352

scholarly journals Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study)

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044424
Author(s):  
Osama Abou-Arab ◽  
Pierre Huette ◽  
Guillaume Haye ◽  
Mathieu Guilbart ◽  
Gilles Touati ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Valve Replacement ◽  
Controlled Trial ◽  
Bypass Graft ◽  
Intervention Group ◽  
University Hospital ◽  
Flow Index ◽  
Control Group ◽  
Registration Number

IntroductionCytokine storm and endotoxin release during cardiac surgery with cardiopulmonary bypass (CPB) have been related to vasoplegic shock and organ dysfunction. We hypothesised that early (during CPB) cytokine adsorption with oXiris membrane for patients at high risk of inflammatory syndrome following cardiac surgery may improve microcirculation, endothelial function and outcomes.Methods and analysisThe Oxicard trial is a prospective, monocentric trial, randomising 70 patients scheduled for cardiac surgery. The inclusion criterion is patients aged more than 18 years old undergoing elective cardiac surgery under CPB with an expected CPB time >90 min (double valve replacement or valve replacement plus coronary arterial bypass graft). Patients will be allocated to the intervention group (n=35) or the control group (n=35). In the intervention group, oXiris membrane will be used on the Prismaflex device (Baxter) at blood pump flow of 450 mL/min during cardiac surgery under CPB. In the control group, cardiac surgery under CPB will be conducted as usual without oXiris membrane. An intention-to-treat analysis will be performed. The primary endpoint will be the microcirculatory flow index measured by sublingual microcirculation device at day 1 following cardiac surgery. The secondary endpoints will be other microcirculation variables at CPB end, 6 hours after CPB, at day 1 and at day 2. We also aim to evaluate the occurrence of major cardiovascular and cerebral events (eg, myocardial infarction, stroke, ischaemic mesenteric, resuscitated cardiac arrest, acute kidney injury) within the first 30 days. Cumulative catecholamine use, intensive care unit length of stay, endothelium glycocalyx shedding parameters (syndecan-1, heparan-sulfate and hyaluronic acid), inflammatory cytokines (tumour necrosis factor (TNF) alpha, interleukin 1 (IL1) beta, IL 10, IL 6, lipopolysaccharide, endothelin) and endothelial permeability biomarkers (angiopoietin 1, angiopoietin 2, Tie2 soluble receptor and Vascular Endothelial Growth Factor (VEGF) will also be evaluated.Ethics and disseminationEthical approval has been obtained from the Institutional Review Board of the University Hospital of Amiens (registration number ID RDB: 2019-A02437-50 in February 2020). Results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.Trial registration numberNCT04201119.

scholarly journals Comparison of lidocaine, huffing maneuver and combination of both in prevention fentanyl induced cough before induction of anesthesia: a double-blind, prospective, randomized placebo-controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Laleh Dehghanpisheh ◽  
Mohammadhossein Eghbal ◽  
Fatemeh Bagheri Baravati ◽  
Pooya Vatankhah
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Placebo Control ◽  
Anesthesia Induction ◽  
Double Blind ◽  
Lidocaine Group ◽  
Cough Reflex ◽  
Significant Difference

Abstract Background Intravenous bolus injection of fentanyl has been frequently reported to be associated with cough reflex during patient anesthesia. However, the search for the most effective protocol continues. This study aimed to compare the effect of reducing cough reflex after injection of fentanyl in a fusion protocol by combining the injections of lidocaine and Huffing maneuver and comparing with a placebo control group, before anesthesia induction. Methods This prospective randomized controlled trial study was performed on 400 patients who were divided into four groups of combined protocol (group 1), lidocaine group (group 2), Huffing maneuver group (group 3), and the control receiving normal saline (group 4). Then patients were injected with 2. 5 μg /kg fentanyl and monitored for 2 min regarding their cough reflex, as well as the severity. Results In group one, 9 patients (9%), in group two, 45 patients (45%), 22 patients (22%) in group three, and in group four, 75 patients (75%), developed cough reflex following fentanyl injection. Also, 13 patients (13%) developed moderate and 4 (4%) developed severe coughs in the control group reported, while no reports of severe or moderate cough were among the intervention groups. There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough. Conclusion By using a combination of lidocaine injection along and Huffing maneuver, better results can be obtained in reducing the frequency, and also the severity of cough followed by fentanyl injection. Trial registration The trial was registered with IRCT.IR (09/03/2018-No. IRCT20141009019470N74).

scholarly journals Effects of Pre-Course Preparation Using a Serious Smartphone Game on Advanced Life Support Knowledge and Skills: A randomized controlled trial. (Preprint)

2019 ◽  
Author(s):  
Pariwat Phungoen ◽  
Songwoot Promto ◽  
Siwit Chantawattanarak ◽  
Sawitree Maneepong ◽  
Korakot Apiratwarakul ◽  
...  
Keyword(s):  
Medical Students ◽  
Life Support ◽  
Controlled Trial ◽  
Advanced Life Support ◽  
Pass Rate ◽  
Control Group ◽  
Multiple Choice Questions ◽  
Clinical Trial Registration ◽  
Registration Number ◽  
Gamified Learning

BACKGROUND Over the past several years, gamified learning has been growing in popularity in various medical educational contexts including cardiopulmonary resuscitation (CPR) training. Furthermore, prior work in Basic Life Support (BLS) training has demonstrated the benefits of serious games as a method for pre-training among medical students. However, there is little evidence to support these benefits with regard to Advanced Life Support (ALS) training OBJECTIVE We compare the effects of a brief pre-course ALS preparation course using a serious smartphone game on students' knowledge, skills, and perceptions in this area with those of conventional ALS training alone. METHODS A serious game (Resus Days) was developed by a Thai physician based on global ALS clinical practice guidelines. Fifth-year medical students were enrolled and randomized to either a game group or a control group. Participants in both groups attended a traditional lecture, but the game group were pretrained using Resus days (1 hour prior to the lecture). All students underwent conventional ALS training, and their abilities were evaluated using multiple choice questions and with hands-on practice on a mannequin. Subjects' attitudes and perceptions about the game were evaluated using a questionnaire. RESULTS A total of 105 students participated in the study and were randomly assigned to either the game group (n = 52) or the control group (n = 53). Students in the game group improved at a higher rate on the algorithm knowledge test compared with those in the control group (17.33±1.93 vs. 16.60±1.97, p=0.01). The game group's pass rate on the skill test was also higher, but not to a statistically significant extent (79% vs. 66%; p=0.09). Students also indicated high satisfaction with the game (9.02±1.11 out of 10). CONCLUSIONS Engaging in game-based preparation prior to an ALS training course resulted in greater improvements to medical students’ algorithm knowledge scores than attending the course alone. CLINICALTRIAL The clinical trial registration number is TCTR20190809002.

Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽  
2020 ◽  
pp. 1-7
Author(s):  
Karien Hill ◽  
Shawn Somerset ◽  
Ralf Schwarzer ◽  
Carina Chan
Keyword(s):  
Suicide Prevention ◽  
Suicide Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Bystander Intervention ◽  
Self Report ◽  
Innovative Technology ◽  
Control Group ◽  
Intervention Model ◽  
Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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