Reducing Pain and Anxiety in the Blood Collection Unit: The Impact of the Child-Friendly Design.

Purpose: The study aimed to examine the effect of a child-friendly design on the pain and anxiety levels during blood draw in children aged 1-3 years and the satisfaction levels of their parents toward the environment in which they receive health care services. Methods: The nonrandomized study was conducted with 158 children aged 1-3 years and their parents. Data were obtained with the "Personal Information Form," "Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale," "Visual Analog Scale (VAS) Anxiety Scale," and "Parental Satisfaction Scale-VAS." Data were collected from the control group before the design and from the intervention group after the design. Results: During the blood draw, the VAS Anxiety score of the children in the intervention group was 3.17 ± 1.44 and that of the control group was 7.00 ± 2.51 (t = 246.500, p < .001). The FLACC score was 3.94 ± 1.65 in the intervention group and 7.32 ± 2.51 in the control group (t = 915.000, p < .001). The mean satisfaction scores of the parents in the intervention group for the environment where they received health care were 10.00 ± 0.00, and those of the parents in the control group were 4.85 ± 1.68 (test = -11.561, p < .001). Conclusion: The child-friendly design effectively reduced children's pain and anxiety levels during blood draws and increased parents' satisfaction with the environment in which health care was received. Practical Implications: Implementing a child-friendly design in blood collection units is recommended to alleviate the pain and anxiety associated with children's blood draws, thereby enhancing parental satisfaction with the care provided.

Autonomic, endocrine, and psychological stress responses to different forms of blood draw.

BACKGROUND: Although fingerstick is often favorably compared to venipuncture as a less invasive method of drawing blood for clinical labs, there is little empirical research that compares physical and psychological stress responses to fingerstick vs. venipuncture (blood draw using a needle in the arm) within the same person. METHODS AND FINDINGS: We assessed changes in cortisol (a stress hormone), heart rate variability (a marker of autonomic stress), and psychological stress in 40 healthy women who completed both venipuncture and fingerstick. Contrary to our predictions, there was a significant decline in cortisol across conditions, with greater decline from pre- to post-draw in response to venipuncture than fingerstick. There were similar patterns of rise and fall in heart rate variability in both types of blood draw, suggestive of mild vasovagal responses. Psychological measures of stress (such as negative emotion and perceived stress) were generally stronger predictors of participant's reported pain and blood draw preferences than physical stress measures. CONCLUSIONS: These findings challenge the characterization of fingerstick as necessarily "less invasive" than venipuncture, as participant's stress responses to fingerstick were equivalent to (and for some measures greater than) their response to venipuncture. Heart rate variability response to fingerstick significantly predicted that individual's vasovagal-like responses to venipuncture, suggesting that measuring heart rate variability during pre-donation hemoglobin testing may identify donors at risk for adverse events during venipuncture.

Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial.

OBJECTIVE: To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes). RESEARCH DESIGN AND METHODS: Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks. RESULTS: Participants were randomized to HCL (n = 61) or control (n = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA1c was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19]; P < 0.0001). For HCL, HbA1c was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2]; P < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9]; P < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively. CONCLUSIONS: In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.

Kidney transplant recipient's perceptions of blood testing through microsampling and venepuncture.

A survey of kidney transplant recipients receiving two innovative microsampling methods, dried blood spot and volumetric absorptive microsampling using patient reported methodology. A total of 39 adult transplant patients underwent venepuncture and finger prick-based blood draws on two occasions. They completed a survey of blood test understanding, tolerability, preferences and the burden associated with venepuncture compared with microsampling. A total of 85% of participants (n = 33) preferred finger prick-based sampling and 95% (n = 37) were interested in blood collection using self sampling by finger prick at home; 33% (n = 13) of participants experienced blood test anxiety. To quantify time burden of providing venous samples a total of 44% (n = 17) spent greater than 1 hour to travel and provide venous samples. This study observed a patient preference for microsampling for blood sampling as an alternative to venepuncture in the management of their kidney transplant.

Obtaining plasma to measure baseline corticosterone concentrations in reptiles: How quick is quick enough?

There is growing interest in the use of glucocorticoid (GC) hormones to understand how wild animals respond to environmental challenges. Blood is the best medium for obtaining information about recent GC levels; however, obtaining blood requires restraint and can therefore be stressful and affect GC levels. There is a delay in GCs entering blood, and it is assumed that blood obtained within 3 min of first disturbing an animal reflects a baseline level of GCs, based largely on studies of birds and mammals. Here we present data on the timing of changes in the principle reptile GC, corticosterone (CORT), in four reptile species for which blood was taken within a range of times 11 min or less after first disturbance. Changes in CORT were observed in cottonmouths (Agkistrodon piscivorus; 4 min after first disturbance), rattlesnakes (Crotalus oreganus; 2 min 30 s), and rock iguanas (Cyclura cychlura; 2 min 44 s), but fence lizards (Sceloporus undulatus) did not exhibit a change within their 10-min sampling period. In both snake species, samples taken up to 3-7 min after CORT began to increase still had lower CORT concentrations than after exposure to a standard restraint stressor. The "3-min rule" appears broadly applicable as a guide for avoiding increases in plasma CORT due to handling and sampling in reptiles, but the time period in which to obtain true baseline CORT may need to be shorter in some species (rattlesnakes, rock iguanas), and may be unnecessarily limiting for others (cottonmouths, fence lizards).

Mothers' Decisions About Donating Newborns' Blood Spots for Research: A Qualitative Study.

Residual dried blood spots from millions of newborns are being stored and used for research. The state of Michigan proactively developed a broad consent process for research use of newborns' blood spots. However, the extent to which mothers make informed choices about this research is unclear. A descriptive, qualitative study was conducted examining this issue. Twenty-nine observations of the consent process and 20 semistructured interviews were conducted with mothers on the postpartum unit of a large, academic hospital in Michigan. Content analysis of the transcripts was conducted. While most mothers agreed to donate the blood spots (n = 14/20; 70%), findings indicated that most decisions were uninformed (n = 16/20; 80%), as mothers lacked knowledge of biobanking research. Misunderstandings about anonymity, the consenter's credentials, and entity conducting the research seemed to influence decision making. Suggestions for improving the consent process include (1) changing the venue of blood spot education and consent from the postpartum period to the perinatal period, (2) strengthening the depth of information and delivery of information provided about the topic, including ethical and values clarification, and (3) increasing consenter education and training. Implementation may help increase the proportion of informed decisions.

Estimating the risk of blood donation fainting for self versus others: the moderating effect of fear.

BACKGROUND: People overestimate the likelihood that blood donors will experience faint and prefaint reactions, particularly if they are themselves fearful of having blood drawn. This study investigated the influence of making a risk assessment for oneself versus others, and examined whether providing information about the low base rates of reactions affected donation attitude, anxiety, and intention. STUDY DESIGN AND METHODS: An anonymous online survey was completed by 3702 individuals (53.9% female; mean age, 36.9 years; standard deviation, 12.1 years; range, 18-84) that included questions about fear of having blood drawn and estimation of the risk of donation-related faint and prefaint symptoms for themselves and others. A random one-half of the respondents received accurate information about the proportion of whole blood donors who experience such reactions before all participants completed questions concerning their donation attitude, anxiety, and intention. RESULTS: Estimates of both faint and prefaint reactions revealed a pattern of lower perceived risk for self versus others among individuals with low fear, and higher perceived risk for self versus others among those with high fear. Provision of accurate information about risk of reactions was associated with more positive donation attitudes (F[1, 3692] = 8.182, p = 0.004) and intentions (F[1, 3692] = 10.137, p = 0.001) but did not significantly affect anxiety. CONCLUSION: Donation-related fear is associated with inflated expectancies of adverse events, especially regarding oneself. Such fear may be particularly important to address, as it has both a direct and indirect negative effect on donor retention.

Acceptability and feasibility of HIV testing in general medicine by ELISA or rapid test from finger-stick whole blood.

OBJECTIVES: Guidelines recommend routine universal HIV testing in adults to reduce the pool of infected patients unaware of their status, without specific recommendations concerning the method. We compared acceptability and feasibility of HIV testing by ELISA tests or rapid tests from finger-stick whole blood. METHODS: Prospective randomized multi-center study comparing acceptability and feasibility of routine universal HIV testing by ELISA tests, with a charge, subsequently reimbursed by Social Security for affiliated patients, or rapid tests from finger-stick whole blood, without any charge from the patients or the general practitioner for the study. A single investigator performed all interventions. After consent, all adults (18-70 years old) consulting their general practitioner in Paris, France, unaware of their status, were enrolled. Testing was performed immediately for the patients in the rapid test arm; a prescription was given for testing in a lab for the patients in the ELISA arm. The primary endpoint was acceptability of each method. The secondary endpoint was feasibility of each method, assessed one month after the consultation. RESULTS: Two hundred and seventy patients were enrolled: 133 patients in the ELISA arm, 137 in the rapid test arm. Acceptability of the rapid test (92%) was higher than that of the ELISA (63.9%), P<0.0001. Feasibility of the rapid test (100%) was higher than that of the ELISA (50.5%), P<0.0001. A center effect was shown concerning feasibility of ELISA but not concerning feasibility of rapid tests. CONCLUSION: Rapid testing from finger-stick whole blood is more acceptable and feasible than ELISA for routine universal HIV testing. A larger use of rapid tests, ideally free of charge, by general practitioners could reduce the pool of infected patients unaware of their status.

Pricks of Conscience: A Needle-Phobic Patient's Experience of Compassionate Nursing Care 
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An oncology nurse's warmth, humor, and compassionate care have helped even the odds in my wife's decade-long battle with incurable cancer. Needle phobia and a complex chemotherapy regimen have made for a challenging course of treatment. However, working closely with us, my wife's care team has given us back the control that can so easily ebb with remission and relapse. 
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A pilot study to understand feasibility and acceptability of stool and cord blood sample collection for a large-scale longitudinal birth cohort.

BACKGROUND: Few data are available to guide biological sample collection around the time of birth for large-scale birth cohorts. We are designing a large UK birth cohort to investigate the role of infection and the developing immune system in determining future health and disease. We undertook a pilot to develop methodology for the main study, gain practical experience of collecting samples, and understand the acceptability of sample collection to women in late pregnancy. METHODS: Between February-July 2014, we piloted the feasibility and acceptability of collecting maternal stool, baby stool and cord blood samples from participants recruited at prolonged pregnancy and planned pre-labour caesarean section clinics at University College London Hospital. Participating women were asked to complete acceptability questionnaires. RESULTS: Overall, 265 women were approached and 171 (65%) participated, with ≥1 sample collected from 113 women or their baby (66%). Women had a mean age of 34 years, were primarily of white ethnicity (130/166, 78%), and half were nulliparous (86/169, 51%). Women undergoing planned pre-labour caesarean section were more likely than those who delivered vaginally to provide ≥1 sample (98% vs 54%), but less likely to provide maternal stool (10% vs 43%). Pre-sample questionnaires were completed by 110/171 women (64%). Most women reported feeling comfortable with samples being collected from their baby (<10% uncomfortable), but were less comfortable about their own stool (19% uncomfortable) or a vaginal swab (24% uncomfortable). CONCLUSIONS: It is possible to collect a range of biological samples from women around the time of delivery, and this was acceptable for most women. These data inform study design and protocol development for large-scale birth cohorts.

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study.

BACKGROUND: The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool that is already widely used in clinical settings in the German speaking areas of Europe. Recent findings indicate that pain responses in preterm neonates are influenced by individual contextual factors, such as gestational age (GA), gender and the number of painful procedures experienced. Currently, the BPSN does not consider individual contextual factors. Therefore, the aim of this study is the validation of the BPSN using a large sample of neonates with different GAs. Furthermore, the influence of individual contextual factors on the variability in pain reactions across GA groups will be explored. The results will be used for a modification of the BPSN to account for individual contextual factors in future clinical pain assessment in neonates. METHODS AND DESIGN: This prospective multisite validation study with a repeated measures design will take place in three university hospital neonatal intensive care units (NICUs) in Switzerland (Bern, Basel and Zurich). To examine the impact of GA on pain responses and their variability, the infants will be stratified into six GA groups ranging from 24 0/7 to 42 0/7. Among preterm infants, 2-5 routine capillary heel sticks within the first 14 days of life, and among full-term infants, two heel sticks during the first days of life will be documented. For each heel stick, measurements will be video recorded for each of three phases: baseline, heel stick, and recovery. The infants' pain responses will be rated according to the BPSN by five nurses who are blinded as to the number of each heel stick and as to the measurement phases. Individual contextual factors of interest will be extracted from patient charts. DISCUSSION: Understanding and considering the influence of individual contextual factors on pain responses in a revised version of the BPSN will help the clinical staff to more appropriately assess pain in neonates, particularly preterm neonates hospitalized in NICUs. Pain assessment is a first step toward appropriate and efficient pain management, which itself is an important factor in later motor and cognitive development in this vulnerable patient population. TRIAL REGISTRATION: The study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

The Effect of Financial Compensation on Willingness to Supply a Child's Blood Sample: A Randomized Controlled Trial.

Medical researchers frequently need to collect blood samples from study participants. The determination of whether and how much compensation to provide to the participants is challenging. Institutional review boards typically allow researchers to provide a compensation that reimburses participants for their time and effort but is not so large as to be coercive. Using a randomized controlled trial, we estimate parents' responsiveness to financial compensation in terms of their willingness to provide their child's blood sample. We find that an additional dollar of compensation raises the willingness to provide a child's blood sample by about 0.5 percentage point at a base of 65%. This corresponds to an elasticity of .33. Using the findings, we provide general guidance on how compensation can be structured to strike a balance between appropriate compensation for participation and coercion.

The Importance of Blood Is Infinite: Conceptions of Blood as Life Force, Rumours and Fear of Trial Participation in a Fulani Village in Rural Gambia.

BACKGROUND: Clinical trials require high levels of participation and low drop-out rates to be successful. However, collecting blood samples from individuals recruited into clinical trials can be challenging when there is reticence about blood-taking. In addition to concerns regarding the feasibility of medical research, fears of 'blood-stealing' and 'blood-selling' have ethical implications related to cultural sensitivity and informed consent. This study explores anxieties around blood-taking during a malaria treatment trial in the Gambia. METHODS: This case study is based on ethnographic research in one theoretically selected village due to the high reticence to screening for the clinical trial 'Primaquine's gametocytocidal efficacy in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine' carried out in the Gambia between 2013 and 2014. Data collection tools included in-depth interviews, participant observation, informal conversations and group discussions. RESULTS: In total only 176 of 411 habitants (42%) in the village accepted having a bloodspot taken to screen for malaria. Although trial recruitment was initially high in the village, some families refused screening when rumours started spreading that the trial team was taking too much blood. Concerns about 'loss of blood' were equated to loss of strength and lack of good food to replenish bodily forces. Families in the study village were concerned about the weakness of their body while they had to harvest their crops at the time of recruitment for the trial. CONCLUSION: A common recommendation to prevent and avoid rumours against public health interventions and trials is the provision of full and consistent information during the consent procedure, which is assumed to lead to more accurate knowledge of the purpose of the intervention and increased trial participation. However, even when information provision is continuous, the emergence of rumours can be related to times of uncertainty and perceptions of vulnerability, which are often a reflection of structural inequalities and diverging value orientations between communities and public health institutions.

Positive Reinforcement Training for Blood Collection in Grizzly Bears (Ursus arctos horribilis) Results in Undetectable Elevations in Serum Cortisol Levels: A Preliminary Investigation.

Training nonhuman animals in captivity for participation in routine husbandry procedures is believed to produce a lower stress environment compared with undergoing a general anesthetic event for the same procedure. This hypothesis rests largely on anecdotal evidence that the captive subjects appear more relaxed with the trained event. Blood markers of physiological stress responses were evaluated in 4 captive grizzly bears (Ursus arctos horribilis) who were clicker-trained for blood collection versus 4 bears who were chemically immobilized for blood collection. Serum cortisol and immunoglobulin A (IgA) and plasma ß-endorphin were measured as indicators of responses to stress. Plasma ß-endorphin was not different between the groups. Serum IgA was undetectable in all bears. Serum cortisol was undetectable in all trained bears, whereas chemically immobilized bears had marked cortisol elevations (p < .05). The highest cortisol elevations were found in 2 bears with extensive recent immobilization experience. These findings support the use of positive reinforcement training for routine health procedures to minimize anxiety.

Mothers' Views on Longer Storage of Neonatal Dried Blood Spots for Specific Secondary Uses.

BACKGROUND: Neonatal dried blood spots (DBS) present a wealth of data. Currently, many countries discuss DBS storage, management and use. We collected data in the Netherlands on the awareness and views of an unheard stakeholder: mothers (-to-be). METHODS: A survey was conducted on an Amsterdam pregnancy fair website in 2011. We included 1,272 women who were pregnant and/or had at least one child ≤5 years old. A descriptive analysis was used to score the awareness of and views on policies regarding the length of storage and secondary use. RESULTS: 18.9% of mothers (n = 1,272) were aware of all five current DBS screening, storage and use policies. The views were positive for all ten potential specific secondary uses. Most support was given to etiology research, while test development by a company was least supported. Extending the DBS storage beyond the 5-year status quo was approved by 67.8% of the respondents, indefinite storage was approved by 54.7%. CONCLUSION: Mothers indicate support of several secondary uses and prolonged storage of DBS but report a low awareness of current storage and secondary use policies. Efforts must be made to involve parents as key stakeholders in DBS policies. This could be achieved through a parent-led advisory structure.

Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.

BACKGROUND: To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. METHODS: 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). RESULTS: Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. CONCLUSIONS: Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.

A cross sectional survey of the barriers for implementing rapid HIV testing among French general practitioners.

In France, almost 30,000 people are unaware of their HIV-positive status. Innovative screening strategies are essential to reach this population. The aim of this study was to describe the acceptability of rapid HIV testing (RHT) among French general practitioners (GPs) working in the south of France and barriers for implementing this strategy. We analysed an anonymous questionnaire sent by mail to GPs about demographic data, routine practice, knowledge of RHT and barriers to its use. Between 1 April and 30 September 2013, out of the 165 GPs contacted, 78 returned the questionnaires. The GPs' mean age was 52 years; 49 were men. Fifty-one GPs reported that their registered patients included at least one HIV-infected person and 70 GPs reported taking care of high-risk patients. Sixty-three percent of GPs reported being interested in using RHT in their daily practice. The main reasons reported by uninterested GPs were: greater confidence in standard HIV testing, difficulties including RHT during the routine consultation, difficulties to screen for other sexually transmitted infections simultaneously, and difficulties to deliver a positive result. French National Authorities for Health propose to screen the population at least once in their lifetime and high-risk people at least once a year. In order to achieve this aim, RHT should be included in the GPs' arsenal for HIV testing. We showed a high acceptability of RHT by GPs. If specific and adapted training is developed, and if solutions to barriers reported by GPs are found, RHT could be implemented in to their routine activity.

Children's views on microneedle use as an alternative to blood sampling for patient monitoring.

OBJECTIVES: To explore children's views on microneedle use for this population, particularly as an alternative approach to blood sampling, in monitoring applications, and so, examine the acceptability of this approach to children. METHODS: Focus groups were conducted with children (aged 10-14 years) in a range of schools across Northern Ireland. Convenience sampling was employed, i.e. children involved in a university-directed community-outreach project (Pharmacists in Schools) were recruited. KEY FINDINGS: A total of 86 children participated in 13 focus groups across seven schools in Northern Ireland. A widespread disapproval for blood sampling was evident, with pain, blood and traditional needle visualisation particularly unpopular aspects. In general, microneedles had greater visual acceptability and caused less fear. A patch-based design enabled minimal patient awareness of the monitoring procedure, with personalised designs, e.g. cartoon themes, favoured. Children's concerns included possible allergy and potential inaccuracies with this novel approach; however, many had confidence in the judgement of healthcare professionals if deeming this technique appropriate. They considered paediatric patient education critical for acceptance of this new approach and called for an alternative name, without any reference to 'needles'. CONCLUSIONS: The findings presented here support the development of blood-free, minimally invasive techniques and provide an initial indication of microneedle acceptability in children, particularly for monitoring purposes. A proactive response to these unique insights should enable microneedle array design to better meet the needs of this end-user group. Further work in this area is recommended to ascertain the perspectives of a purposive sample of children with chronic conditions who require regular monitoring.

A prospective randomised control study: reduction of children's pain expectation using a picture book during blood withdrawal.

OBJECTIVES: Blood drawings are very painful and stressful for children. In a prospective control group study we investigated if using a picture book could reduce the children's pain expectation. In addition, the children's pain experience and the observed pain behaviour was monitored. PATIENTS/METHODS: Block-randomization were used and 120 children at the age of 6-12 years who were visiting the general pediatric and coagulation outpatient clinics were included in this study. Pain expectation and experience were assessed with the Face-Pain-Scale-Revised and the pain behavior with the Faces-Legs-Activity-Cry-Consolability Scale. Multivariate covariance analysis was used for data analysis. RESULTS: The results showed that with statistical controlling the influence of the primary pain expectation (baseline) the pain expectation before blood withdrawal was reduced significantly (p=0.001) and effectively (ES=0.56) using the picture book. Children who received no local anaesthesia reported that they felt less pain during blood drawing after reading the picture book. The few children with local anaesthesia reported no benefit from the picture book. The observed use of local anaesthesia was very heterogeneous. CONCLUSIONS: The results recommend the usage of this picture book in everyday practice, if the use of local anaesthesia could not be used in an appropriate way.