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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.

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.

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.

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.

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.

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.

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.

Interindividual variability in epirubicin exposure limits the efficacy of standard chemotherapy dosing based on body surface area (BSA) in breast cancer. This study evaluated a novel liquid-based capillary microsampling technology, True Dose ® , to enable decentralized therapeutic drug monitoring (TDM). It integrates internal standards (IS) at the blood collection point, enabling the immediate precipitation of proteins and stabilization of analytes. Analytical validation using liquid chromatography-tandem mass spectrometry (LC-MS/MS) showed that epirubicin signal responses from capillary samples corresponded with those from conventional venous samples, achieving R² values of ≥ 0.99. Intra-assay coefficient of variation (CV%) improved over time, decreasing from up to 18.6% at T0 to ≤ 11% from Day 3 onward, consistent with time-dependent matrix equilibration and improved extraction efficiency. Pre- and post-activation stability studies confirmed analyte integrity for up to 14 days at ambient temperatures. Hematocrit levels ranging from 7 to 18 g/dL showed no more than 17% signal variation, confirming matrix stability. In a clinical substudy involving 4 early-stage breast cancer patients, capillary-collected samples ( n  = 4 Cap-TD) yielded epirubicin/doxorubicin ratios that differed by no more than 15% from venous-derived samples; interpretation is limited by the small sample size. The findings support the feasibility of the True Dose ® system as a method for decentralized TDM of anthracycline (epirubicin) chemotherapy. The technology demonstrated analyte stability under room temperature storage for up to 14 days, time-dependent improvement in analytical precision, and minimal hematocrit bias, warranting further investigation in a broader clinical setting. Clinical trial identification: EudraCT 2017-000641-44 (registered 27 Feb 2017); EUCT 2024-514818-12-00 (CTIS, transitioned from EudraCT).

Purpose To compare the feasibility and safety of three approaches for bilateral adrenal venous sampling (AVS) and their influence on the outcomes of adrenalectomy for dominant lateral primary aldosteronism (PA). Methods 182 PA patients who underwent AVS at Fuwai Hospital between January 2022 and March 2024 were enrolled. According to the puncture access, patients were divided into three groups: simultaneous AVS via antecubital approach group (Group A, N  = 48), simultaneous AVS via femoral approach group (Group B, N  = 44) and sequential AVS via antecubital approach group (Group C, N  = 90). The baseline data, procedure parameters, success rates, complication rates and follow-up data were analyzed. Results The baseline characteristics did not differ significantly among three groups (all P  > 0.05). The procedure time (18.9 ± 7.4 min vs. 25.2 ± 7.5 min; P  < 0.001) and fluoroscopy time (7.1 ± 3.8 min vs. 10.8 ± 6.2 min; P  < 0.001) were shorter in Group A than in Group C. However, there was no significant difference between Group A and B (all P  > 0.05). The bilateral sampling success rates in Groups A, B and C were 93.8%, 93.2% and 91.1%, respectively, which were not significantly different ( P  = 0.936). One (0.5%) adrenal haematoma was recorded in Group B. The complete clinical success rate ( P  = 0.894) and complete biochemical success rate ( P  = 0.954) were not significantly different in patients with dominant lateralization who underwent adrenalectomy. Conclusion This study revealed that three approaches for AVS are safe and feasible, with similar outcomes after adrenalectomy. Simultaneous AVS via antecubital approach might be a better choice considering its shorter procedure and fluoroscopy time and comfort.