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2,394 result(s) for "Blood Specimen Collection"
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Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond
Home blood self-collection devices can enable remote monitoring, but their implementation requires validation. Our objectives were to explore (i) the impact of sampling sites and topical analgesia on capillary blood volume and pain perception and (ii) the safety, acceptability, and failure of capillary self-collection among adults and children using the Tasso-SST device. We conducted a two-phase study. The investigational phase consisted of two on-site cross-sectional studies in healthy adult participants (≥ 12 years) and children (1-17 years) with their accompanying parent. Adults received 4 capillary samplings, where puncture sites and topical analgesia were randomized in a factorial design, and a venipuncture; children (and one parent) had one capillary sampling. The two co-primary outcomes were blood volume and pain. The implementation phase was conducted in two multicentre trials in participants choosing remote visits; blood volume, collection failure, adverse events, and satisfaction were documented. In the investigational phase, 90 participants and 9 children with 7 parents were enrolled; 15 adults and 2 preschoolers participated in the implementation phase. In the adult investigational study, the device collected a median (25%, 75%) of 450 (250, 550) μl of blood with no significant difference between the puncture site, topical analgesia, and its interaction. Using topical analgesia reduced pain perception by 0.61 (95% CI: 0.97, 0.24; P <0.01) points on the 11-point scale; the pain reduction varied by puncture site, with the lower back showing the most significant decrease. Overall, combining all studies and phases, the median volume collected was 425 (250, 500) μl, and the device failure rate was 4.4%; minor adverse effects were reported in 8.9% of the participants, all were willing to use the device again. Capillary blood self-collection, yielding slightly less than 500 μl, proves to be a safe and relatively painless method for adults and children, with high satisfaction and low failure rates. The puncture site and topical analgesia do not affect blood volume, but topical analgesia on the lower back could reduce pain.
A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture
Arterial punctures for assessment of arterial blood-gases can be a painful procedure. Lidocaine can be used to reduce pain prior to needle insertion but it is not a widely accepted practice. The purpose of this study was to determine whether a large size needle induces more pain compared to a smaller size needle for radial arterial puncture and to assess the anxiety associated with radial arterial punctures. We conducted a prospective, double-blind, randomized, controlled, monocentric study including all outpatients who had a planned assessment of arterial blood gas analysis. Patients were randomized to have the arterial puncture performed with a 23 or a 25 G needle. The main judgement criteria was pain during arterial puncture. Visual analogue scale for pain (VAS-P) and visual analogue scale for anxiety (VAS-A) were used to assess pain and anxiety during radial arterial puncture. Two hundred consecutive patients were randomized. The 25 G needle was as painful as the 23 G needle (6.63 mm [0-19 mm] vs. 5.21 mm [0-18.49 mm], respectively, p = 0.527). Time for arterial puncture was longer with the 25 G needle than with the 23 G needle (42 s [35-55 s] vs. 33 s [24.5-35 s], respectively, p = 0.002). There was a correlation between the level of anxiety prior to the arterial puncture and the pain experienced by the patients (p: 0.369, p<0.0001). There was a correlation between the pain experienced by patients and the anxiety experienced in anticipation of another arterial puncture (p: 0.5124, p<0.0001). The use of 23 G needle allows quicker arterial sampling and is not associated with increased pain and symptoms. Anxiety was correlated with the pain experienced by patients during arterial punctures. Clinicaltrials.gov: NCT02320916.
The effect of the simulated intrauterine sound on behavioral and physiological indices of pain during capillary blood sampling for screening preterm infants: a randomized clinical trial study
Introduction Due to medical procedures, preterm infants are at high risk for side effects of pain. In this regard, heel lancing for capillary blood sampling is a common painful procedure. The present study was conducted to assess the effectiveness of a simulated intrauterine sound on behavioral and physiological indices of pain due to heel-prick blood sampling in preterm infants. Methods A double‑blind randomized clinical trial (RCT) was conducted. The data were collected from September 23 to December 22, 2019. We measured the effect of a simulated intrauterine sound on changes in the behavioral and physiological parameters of pain (heart rate, SPO 2 ) caused by heel lance that was measured 5 min before the intervention, during the sampling, and 5 min after the procedure. We measured behavioral pain by video recording the infants’ faces and then the scoring neonatal infant pain scale (NIPS). Heart rate and SPO 2 were measured using a pulse oximeter device. The data were analyzed using analysis of variance (ANOVA) and independent t ‑test in SPSS software version 20.0. Results Eighty infants were randomized (40 in each group). Mean scores NIPS during and after intervention were in the intervention group (3.55 ± 0.84, 95% CI: 3.30–3.80(, and (1.15 ± 0.84, 95%: 0.95–1.35) and in the control group (5.57 ± 0.95, 95% CI:5.30–5.85) and (3.00 ± 0.98) respectively. There were significant differences in scores of NIPS between the two study groups during ( p  < 0.001) and five min after heel lancing ( p  < 0.001). Mean scores of heart rate in the three phases of before, during, and five min after the intervention were respectively in the intervention group (127.57 ± 4.45, 95% CI:126.27-128.99), (131.07 ± 6.54, 95% CI:129.20-133.22), (128.45 ± 5.15, 95% CI:127.02-130.07) and in the control group (128.67 ± 4.57, 95% CI:127.32-130.07), (136.07 ± 7.24, 95% CI:133.90-138.37), and (132.42 ± 6.47, 95% CI:130.37-134.49). There were significant differences in heart rate between the intervention and the control group during ( p  = 0.002) and five min after the heel lance ( p  = 0.003). Mean scores of SPO 2 in the three phases of baseline, during, and five min after the intervention were respectively in the intervention group (96.72 ± 0.93, 95% CI:96.42-97.00), (91.47 ± 1.46, 95% CI:91.05–91.92), (94.17 ± 1.03, 95% CI:93.22-94.00) and in the control group (96.6 ± 0.84, 95% CI:96.35–96.85), (91.5 ± 1.24, 95% CI:91.12–91.87), and (93.60 ± 1.27, 95% CI:93.85–94.50). Conclusion This study showed that the simulated intrauterine sound reduces the behavioral pain and heart rate in the intervention group during and after heel lance. These results suggest using the method during the painful heel lancing to reduce pain parameters in preterm infants.
Effect of a portable therapeutic baby nest designed for neonates on physiological parameters, comfort and pain levels during venous blood sampling: a randomised controlled trial
BackgroundIn Turkey, paediatric emergency departments often lack the specialised environments required for invasive procedures on neonates. Given their developmental vulnerability, it is crucial to use interventions that reduce discomfort and support physiological stability. This study introduces the portable therapeutic baby nest (PTBN), designed to provide developmentally supportive care aligned with the principles of the Newborn Individualized Developmental Care and Assessment Program.MethodsThis two-phase study included 80 term neonates (40 per group). First, the PTBN was developed from February to April 2022. Second, its effectiveness was evaluated through a randomized controlled trial conducted from May to September 2022. The experimental group underwent venous blood sampling in the PTBN, and the control group on a standard stretcher. All procedures were video-recorded and assessed by two blinded nurses using the Physiological Parameter Monitoring Form, COMFORTneo and Neonatal Infant Pain Scale (NIPS).ResultsBaseline characteristics were similar across groups (p>0.05). During and after sampling, the PTBN group had significantly lower heart and respiratory rates, higher oxygen saturation and lower NIPS and COMFORTneo scores compared with controls (p<0.05).ConclusionThe PTBN improved physiological stability, comfort and pain outcomes during venous sampling in neonates.Trial registration numberNCT05442619.
Impact of breast milk on cortical pain response in newborns during the heel prick procedure: a randomized controlled trial
Objective To investigate the effects of breast milk on cortical pain response and behavioral response in newborns during heel-prick procedure. Study design A prospective, randomized controlled trial was conducted on healty-term newborns, undergoing heel blood sampling. Infants were randomly assigned to study group with receive orally 2 ml breast milk ( n  = 45) or a control group with no intervention ( n  = 45). A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation (rScO 2 ), while neonatal pain expression was assessed by Neonatal Pain, Agitation, and Sedation Scale (N-PASS). Results The N-PASS score ( p  = 0.001) and the crying time ( p  = 0.017) were significantly lower in the study group compared to the control group. Although the mean rScO 2 values decreased in both groups during the procedure, the percent change in rScO 2 was not significant difference between two groups. Conclusion Breast milk administration decreases behavioral responses to a noxious stimulus without reducing the cortical response to pain. Clinical trial registration This trial was registered under ClinicalTrials.gov identifier no. NCT05961904.
Effect of Yakson Touch and White Noise on Pain in Neonatal Heel Blood Collection: A Randomized Controlled Study
As part of preventive health services, infants are exposed to painful procedures, such as venous interventions, injections, and heel blood collection. Infants, in particular, are sensitive and vulnerable to untreated pain. This study aims to evaluate the effect of Yakson touch and white noise on pain in newborn heel blood collection. Yakson touch include the interaction between the caregiver and the care recipient. The study was conducted using a parallel randomized controlled experimental design. The research was conducted during the Guthrie screening test routinely performed on newborns. The study was carried out at the Family Health Center, which has the highest number of patients in a province in the Eastern Anatolia Region of Turkey between May 1st and August 30th, 2022. A total of 66 babies with a gestational age of 37-40 weeks were included in the study. In the study, infant participants were randomly assigned to one of three groups: the Yakson Touch Group (n=22), the White Noise Group (n=22), and the Control Group (n=22). Infants in the Yakson Touch Group received the Yakson touch from the same researcher. Infants in the White Noise Group listened to a song \"Don't Let Your Baby Cry 2\" from the album \"Colic\". Infants in the Control Group received routine intervention procedures. The study data were collected using the Introductory Information Form and the Newborn Infant Pain Scale (NIPS). After the procedure, the mean Yakson Touch Group of the NIPS score was 2.04±1.17, the mean White Noise Group of the NIPS score was 2.80±1.47, and the mean Control Group of the NIPS score was 3.72±1.07. There was a significant difference between the groups after the procedure (P < .001; ηp2=0.248 ). The Yakson touch procedure was found to be the most effective at decreasing the pain score, and white noise was the second most effective. Yakson touch is more effective than white noise in controlling pain due to invasive procedures in babies.
Measuring the performance of an artificial intelligence–based robot that classifies blood tubes and performs quality control in terms of preanalytical errors: A preliminary study
Abstract Objectives Artificial intelligence–based robotic systems are increasingly used in medical laboratories. This study aimed to test the performance of KANKA (Labenko), a stand-alone, artificial intelligence–based robot that performs sorting and preanalytical quality control of blood tubes. Methods KANKA is designed to perform preanalytical quality control with respect to error control and preanalytical sorting of blood tubes. To detect sorting errors and preanalytical inappropriateness within the routine work of the laboratory, a total of 1000 blood tubes were presented to the KANKA robot in 7 scenarios. These scenarios encompassed various days and runs, with 5 repetitions each, resulting in a total of 5000 instances of sorting and detection of preanalytical errors. As the gold standard, 2 experts working in the same laboratory identified and recorded the correct sorting and preanalytical errors. The success rate of KANKA was calculated for both the accurate tubes and those tubes with inappropriate identification. Results KANKA achieved an overall accuracy rate of 99.98% and 100% in detecting tubes with preanalytical errors. It was found that KANKA can perform the control and sorting of 311 blood tubes per hour in terms of preanalytical errors. Conclusions KANKA categorizes and records problem-free tubes according to laboratory subunits while identifying and classifying tubes with preanalytical inappropriateness into the correct error sections. As a blood acceptance and tube sorting system, KANKA has the potential to save labor and enhance the quality of the preanalytical process.
Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial
Ultrasound (US) guidance has yet to prove its applicability in radial arterial blood gas analysis (ABGA) punctures. The main objective of our study was to compare the number of first-attempt successes (NFAS) for radial arterial puncture in difficult patients with or without US guidance. The Secondary aims were to compare the number of punctures (NOP), puncture time, and patient pain. In this single-center, randomized controlled trial, patients who required a radial ABGA and in whom the arterial puncture was assessed as difficult (because of non-palpable radial arteries or two previous puncture failures by a nurse) were assigned to the US group or no-US (NUS) group (procedure performed by a trained physician). Thirty-six patients were included in the US group and 37 in the NUS groups. The NFAS was 7 (19%) in the NUS group and 19 (53%) in the US group. The relative risk of success in the US group was 2.79 (95% CI,1.34 to 5.82), p = 0.01. In the NUS and US groups, respectively, the median NOP was 3 [2; 6] vs. 1 [1; 2], estimated difference -2.0 (95%CI, -3.4 to -0.6), p < 0.01; the respective puncture time was 3.1 [1.6; 5.4] vs. 1.4 [0.6; 3.1] min, estimated difference -1.45 (95%CI, -2.57 to -0.39), p = 0.01; the respective median patient pain was 6 [4; 8] vs. 2 [1; 4], estimated difference -4.0 (95%CI, -5.8 to -2.3); p < 0.01. US guidance by a trained physician significantly improves the rate of success in difficult radial ABGA patients.
Comparison of facilitated tucking and oral dextrose in reducing the pain of heel stick in preterm infants: a randomized clinical trial
Background With the increase in hospitalization of premature infants in emergency departments and the painful procedure in these sectors, appropriate methods of pain relief are required. This study aimed to compare the effect of oral dextrose and facilitated tucking in the reduction of pain during heel sticks in premature infants and assess their effectiveness and feasibility for use in emergency settings. Methods This study was a randomized controlled clinical trial with cross-over design. Sixty infants were recruited from a Neonatal Intensive Care Unit (NICU) at Valiasr hospital in Tehran, Iran from March 2015 to September 2016. They were randomly allocated into three groups (no pain relief method, oral dextrose and facilitated tucking). Six blood samples were collected by heel stick for each infant. Oral dextrose and facilitated tucking were compared with the routine method of blood sampling and pain was measured two times for each method. The pain scores was measured by the Premature Infant Pain Profile (PIPP). Repeated Measure ANOVA, ANOVA and Scheffe post-hoc test were used with SPSS 16. Results The pain score’s increase during heel stick was significantly lower after using oral dextrose (3.58 ± 0.34) and facilitated tucking (5.58 ± 0.53) in comparison to the routine method (8.91 ± 0.18) of blood sampling ( P  < 0.001, η 2  = 0.971). Oral dextrose was more effective than facilitated tucking ( P  < 0.001, Cohen’s d = 4.49). The emergency nurses rated oral dextrose as easier (t = 2.20, df = 118, p  = 0.02, Cohen’s d = 0.39) and more applicable method (t = 2.99, df = 118, p  = 0.003, Cohen’s d = 0.54) for the emergency department. Conclusions Facilitated tucking is an effective method of pain reduction which can be used in the absence of oral dextrose, in a situation in which it is contraindicated or in combination with oral dextrose. Based on the increase of infant’s admission in emergency department future studies are needed to identify the best method of pain reduction for procedures in this setting. Trial registration Current Controlled Trials IRCT201408029568N9 , 2014-09-08.