scholarly journals Role of Predonation Hydration in the Prevention of Postdonation Vasovagal Reactions in First Time Blood Donors: A Randomised Controlled Trial

2021 ◽  
Author(s):  
Vijayalakshmi Kuttath ◽  
Harikumaran Nair ◽  
Muraleedharan Nair
Keyword(s):  
Sensitivity Analysis ◽  
Randomised Controlled Trial ◽  
Blood Donors ◽  
Blood Donation ◽  
Controlled Trial ◽  
Statistical Significance ◽  
P Value ◽  
Vasovagal Reactions ◽  
Randomised Controlled ◽  
First Time

Introduction: A crucial component of the effort to meet the growing demand for blood is the recruitment and retention of young novice blood donors. Reducing postdonation syncopal reactions could have a beneficial impact on donor convenience, safety, and desire to donate again. Aim: To evaluate the effectiveness of predonation hydration over standard blood donation in the prevention or decrease in severity of postdonation Vasovagal Reactions (VVR) in hydrated blood donors in comparison with the non hydrated group. Materials and Methods: The randomised controlled trial was conducted on 953 first time voluntary blood donors. Donors in the intervention arm drank 250 mL water 30 minutes before blood donation, while those in the control group did not receive any intervention. Blood was collected by standard protocol. Outcome, VVR, if present was graded as mild, moderate, and severe. Analysis of results were done using Statistical Package for the Social Sciences (SPSS) version 16.0. A sensitivity analysis was also done to consider the dropouts from the study. Results: A total of 900 participants were included in the study, of which 443 were controls and 457 were cases. An effect size of 6.1%, a Relative Risk (RR) of 0.54 {95% Confidence Interval (CI)=0.36-0.81} and a risk reduction of 45% was arrived at, pointing to a protective role for predonation hydration in preventing VVR. There was a significant reduction in the severity of VVR in the predonation hydration group compared to the standard blood donation group (p-value=0.002). The protective effect of hydration on decreasing the occurrence and severity of VVR had statistical support in males in the moderate and severe grades (p-value=0.017). A similar statistical significance was not established in females (p-value=0.173). Sensitivity analysis did not reveal a difference in the statistical significance of variables between compared groups. Conclusion: Predonation hydration was found to be effective in preventing and decreasing the severity of VVR in novice blood donors.

scholarly journals Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Life Expectancy ◽  
Statin Therapy ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
P Value ◽  
Cvd Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

scholarly journals Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042101
Author(s):  
Saba Aijaz ◽  
Sana Sheikh ◽  
Asad Pathan
Keyword(s):  
Randomised Controlled Trial ◽  
Radial Artery ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Ease Of Use ◽  
P Value ◽  
Radial Compression ◽  
Open Label ◽  
Scientific Publications ◽  
Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

scholarly journals Cognitive–behavioural therapy for anxiety in dementia: pilot randomised controlled trial

2015 ◽  
Vol 206 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Aimee Spector ◽  
Georgina Charlesworth ◽  
Michael King ◽  
Miles Lattimer ◽  
Susan Sadek ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Pilot Randomised Controlled Trial ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Effective Treatments

BackgroundAnxiety is common and problematic in dementia, yet there is a lack of effective treatments.AimsTo develop a cognitive–behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial.MethodA ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n= 25) or TAU (n= 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months.ResultsAt 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (–3.10, 95% CI −6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (–5.37, 95% CI −9.50 to −1.25). Improvements remained significant at 6 months. CBT was cost neutral.ConclusionsCBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.

User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

2019 ◽  
Vol 26 (5) ◽  
pp. 432-438 ◽  
Author(s):  
Alexandra B Hall ◽  
Catherine Ho ◽  
Bianca Albanese ◽  
Lisa Keay ◽  
Kate Hunter ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Instructional Materials ◽  
Control Group ◽  
P Value ◽  
Point Increase ◽  
Comprehension Score ◽  
Child Restraint ◽  
Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

scholarly journals A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
See Ling Loy ◽  
Thilagamangai ◽  
Joyce Teo ◽  
Sze Wern Chan ◽  
Nurul Khairani Abdul Razak ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Child Health ◽  
Linear Models ◽  
Controlled Trial ◽  
Text Messages ◽  
Feeding Practice ◽  
Learning Ecosystem ◽  
Mental Wellness ◽  
Randomised Controlled ◽  
First Time

Abstract Background Enhanced parenting self-efficacy (PSE) contributes to positive parenting and future parental-child health. First-time parents, in particular, are in need of support since the pregnancy until post-delivery to strengthen their early PSE. However, there is a lack of effective and sustainable relevant programmes in the community. The Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) aims to develop a self-learning eco-community throughout the pregnancy and early childhood to promote PSE among first-time parents. We apply choice architecture strategy using behavioural nudges and midwife-led continuity care during the first 1000 days, and test their effects on PSE and mother-child health for first-time families in Singapore. Methods This three-arm randomised controlled trial will recruit up to 750 pregnant women from the KK Women’s and Children’s Hospital, Singapore. Participants will be randomly assigned to receive: (1) standard routine care; (2) behavioural nudges (text messages) along with the use of a social media platform; or (3) midwife-led continuity care involving individualised teleconferencing sessions, during pregnancy and post-delivery. Using web-based questionnaires, participants will be assessed for baseline socio-demography and health status in the first visit, with follow-up assessments in the third trimester, at birth, 6-week (primary end-point), 6-, 12-, 18- and 24-month post-delivery. The primary outcome is PSE. Secondary outcomes include health and birth experience, mental wellness, feeding practice, maternal and child nutritional status. Intention-to-treat and per-protocol analyses will be performed using general linear models to test the effects of interventions across three arms. Recruitment has begun in June 2020 and is estimated to complete in September 2022. Discussion This study may identify a sustainable effective strategy in the community by helping first-time parents to have a positive experience during the pregnancy, childbirth and parenthood, leading to an enhanced PSE and health outcomes for both mother and child. Findings from this study will provide insight into the implementation of early parenting and mother-child care programmes. Trial registration ClinicalTrials.gov NCT04275765. Registered on 19 February 2020.

scholarly journals Clinic-based training in comparison to home-based training after first-time lumbar disc surgery: a randomised controlled trial

2008 ◽  
Vol 18 (3) ◽  
pp. 398-409 ◽  
Author(s):  
Ann-Christin Johansson ◽  
Steven J. Linton ◽  
Leif Bergkvist ◽  
Olle Nilsson ◽  
Michael Cornefjord
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Lumbar Disc Surgery ◽  
Disc Surgery ◽  
Home Based ◽  
Randomised Controlled ◽  
First Time
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