Effect of different types of supervised exercise programs on cardiorespiratory and muscular fitness, pain, fatigue, mental health and inflammatory and oxidative stress biomarkers in older patients with post-COVID-19 sequelae "EJerSA-COVID-19": a randomized controlled trial.

BACKGROUND: Many patients with COVID-19 present the so-called post-acute sequelae of COVID-19 such as fatigue, post-stress discomfort, dyspnea, headache, pain mental impairment, incapacity to perform daily physical tasks ant exercise intolerance. This study aims to investigate the effects of different exercise programs on physical and mental fitness, physical condition and biomarkers of the immune system and oxidative stress in older patients with post-COVID-19 sequelae. METHODS: The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology diagnosed by the corresponding physician. The participants will be randomly assigned to the experimental groups: supervised endurance group (SEG, n = 30), supervised strength group (SSG, n = 30), supervised concurrent group (SCG, n = 30), which will perform the corresponding exercise program 3 days a week compared to the control group (CG, n = 30), which will not carry out a supervised exercise program. The design of this project will include measurements of four relevant dimensions; 1) Cardiorespiratory fitness; 2) Muscle fitness; 3) Pain and mental health; and 4) Biomarkers of inflammation and oxidative stress. CONCLUSIONS: The results of this study will provide insights into the effects of different exercise programs on physical and mental fitness, physical condition and biomarkers of the immune system and oxidative stress in older patients with post-COVID-19 sequelae. These findings may be the basis for the formulation of health plans and rehabilitation programs that allow healthy aging and a reduction in the associated morbidity in patients with post-COVID-19 sequelae. TRIAL REGISTRATION: NCT05848518. Registered on May 8, 2023.

Exploring home births in Catalonia (Spain): A cross-sectional study of women's experiences and influencing factors.

AIM: The study explores the experiences of women with low-risk pregnancies and no complications who planned a home birth. DESIGN: A cross-sectional study was conducted using an online questionnaire. METHODS: The questionnaire included socio-demographic, obstetric and perinatal variables. Birth satisfaction was evaluated via the Spanish version of the childbirth experience questionnaire. The study group comprised home-birthing women in Catalonia, Spain. Data were collected from 1 January 2019 to 31 December 2021. Statistical analysis was performed using SPSS. RESULTS: A total of 236 women responded. They reported generally positive experiences, with professional support and involvement being the most highly rated dimensions. Better childbirth experiences were associated with labour lasting less than 12 h, no perineal injuries, no intrapartum transfers to hospital, euthocic delivery and the presence of a midwife. CONCLUSIONS: Women's positive home birth experiences were linked to active participation and midwife support. Multiparous women felt safer. Medical interventions, especially transfers to hospitals, reduced satisfaction, highlighting the need for improved care during home births. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Home births should be included among the birthplace options offered by public health services, given the extremely positive feedback reported by women who gave birth at home. IMPACT: Home birth is not an option offered under Catalonia's public health system only as a private service. The experience of home-birthing women is unknown. This study shows a very positive birth experience due to greater participation and midwife support. The results help stakeholders assess home birth's public health inclusion and understand valued factors, supporting home-birthing women. REPORTING METHOD: The study followed the STROBE checklist guidelines for cross-sectional studies. PUBLIC CONTRIBUTION: Women who planned a home birth participated in the pilot test to validate the instrument, and their contributions were collected by the lead researcher. The questionnaire gathered the participants' email addresses, and a commitment was made to disseminate the study's results through this means.

Physiological responses and behavioural organization of very low birth weight infants during swaddled versus traditional weighing.

AIM: Despite the consequences of neonatal distress and agitation, preterm infants undergo stress owing to weighing procedures. The objective of this study was to enable very low birth weight infants to maintain adequate self-regulation during weighing. DESIGN: This prospective crossover study utilizes a within-subjects design, where intervention days were compared to control days. METHOD: Infants were exposed to both swaddled and unswaddled weighing in an intensive care nursery setting. Nineteen very low birth weight infants were weighed on two consecutive days. Variables of heart rate, respiratory rate and ALPS-Neo score were recorded. RESULTS: Stress score decreased significantly from 1.65 (pre-weight) to 0.23 (weight measurement) in swaddled-intervention periods; conversely, it increased significantly from 1.26 (pre-weight) to 4.97 (weight measurement) in control periods. During weight measurement, heart and respiratory rate were significantly lower for swaddled-intervention days when compared to control days. Given the significant impact of swaddled weighing in reducing stress, this method can be used as an appropriate weighing procedure in intensive care. This research has no patient or public contribution.

Effectiveness of nonpharmacological interventions to prevent adverse events in the intensive care unit: A review of systematic reviews.

BACKGROUND: Different types of interventions have been assessed for the prevention of adverse events. However, determining which patient-safety practice is most effective can be challenging when there is no systematised evidence synthesis. An overview following the best methodological standards can provide the best reliable integrative evidence. OBJECTIVES: The objective of this study was to provide an overview of effectiveness nonpharmacological interventions aimed at preventing adverse events in the intensive care unit. METHODS: A review of systematic reviews (SRs) was conducted according to the Cochrane Handbook and PRISMA recommendations. PubMed, CINAHL, and Cochrane Library were searched for SRs published until March 2022. Two reviewers independently assessed the study's quality, using AMSTAR-2, and extracted data on intervention characteristics and effect on prevention of adverse events. RESULTS: Thirty-seven SRs were included, and 27 nonpharmacological interventions were identified to prevent 11 adverse events. Most of the reviews had critically low methodological quality. Among all the identified interventions, subglottic secretion drainage, semirecumbent position, and kinetic bed therapy were effective in preventing ventilator-associated pneumonia; the use of earplugs, early mobilisation, family participation, and music in reducing delirium; physical rehabilitation in improving muscle strength; use of respiratory support in preventing reintubation; the use of a computerised physician order entry system in reducing risk of medication errors; and the use of heated water humidifier was effective in reducing artificial airway occlusion. CONCLUSIONS: Some nonpharmacological interventions reduced adverse events in the intensive care setting. These findings should be interpreted carefully due to the low methodological quality. SRs on preventing adverse events in the intensive care unit should adhere to quality assessment tools so that best evidence can be used in decision-making.

Futuras líneas de investigación en cuidados sobre dolor, sedación, contenciones y delirium en el paciente crítico / Future lines of research on pain care, sedation, restraints and delirium in the critically ill patient

La valoración y manejo del dolor-analgesia, agitación-sedación, contenciones mecánicas (CM) y delirium en el paciente critico ha ido evolucionando en los últimos años, tal y como recogen las recomendaciones de las Guías de Práctica Clínica (GPC) 1. Sin embargo, todavía quedan cuestiones pendientes, en las que las enfermeras pueden investigar destacando el efecto que los cuidados pueden tener en los resultados de salud sensibles a la práctica enfermera. A continuación, se proponen doce líneas de investigación en cuidados para la orientación de futuros proyectos sobre dolor, sedación, CM y delirium. (AU)

Health Care Professionals' Assessment of Patient Discomfort After Abdominal Surgery.

PURPOSE: The purpose of this study was to classify elements of patients' discomfort in the resuscitation room after open or laparoscopic abdominal surgery as per health care professionals' perceptions. DESIGN: A prospective cross-sectional study at a tertiary hospital in Spain. METHODS: Resuscitation room nurses administered the Postoperative Discomfort Inventory to physicians and nurses with >1 year experience working closely with patients who had undergone abdominal surgery, asking them to score nine items related to patients' discomfort in the first 8 hours after surgery on an 11-point scale (0 = absent to 10 = very severe). Interobserver agreement among proxy reporters was measured with the Spearman's ρ; correlations >0.35 was considered adequate agreement. FINDINGS: Of 125 eligible professionals, 116 (93%) participated (63 [54%] nurses and 53 [46%] physicians; mean age, 38 ± 12 years; 86 [74%] women). Professionals' perception of discomfort differed significantly between patients undergoing open surgery and those undergoing laparoscopic surgery; after open surgery, the most common types were pain (7.1 ± 1.8), movement restriction (7 ± 1.75), and dry mouth (6.6 ± 2.6), whereas after laparoscopic surgery, the most common types were dry mouth (5.85 ± 2.8), abdominal bloating (5.3 ± 2.5), and pain (5 ± 2.2). The Spearman's ρ correlations were inadequate for all items except for dry mouth in open surgery (r = 0.40). CONCLUSIONS: Pain, movement restriction, abdominal bloating, and dry mouth were the main causes of discomfort. Our findings highlight the need to be vigilant for all manifestations of discomfort after abdominal surgery to enable timely treatment.

Medication errors in prescription and administration in critically ill patients.

AIM: To determine the prevalence and magnitude of medication errors and their association with patients' sociodemographic and clinical characteristics and nurses' work conditions. DESIGN: An observational, analytical, cross-sectional and ambispective study was conducted in critically ill adult patients. METHODS: Data concerning prescription errors were collected retrospectively from medical records and administration errors were identified through direct observation of nurses during drug administration. Those data were collected between April and July 2015. RESULTS: A total of 650 prescription errors were identified for 961 drugs in 90 patients (mean error 7[SD 4.1] per patient) and prevalence of 47.1% (95% CI 44-50). The most frequent error was omission of the prescribed medication. Intensive care unit stay was a risk factor associated with omission error (OR 2.14; 1.46-3.14: p < .01). A total of 294 administration errors were identified for 249 drugs in 52 patients (mean error 6 [SD 6.7] per patient) and prevalence of 73.5% (95% CI 68-79). The most frequent error was interruption during drug administration. Admission to the intensive care unit (OR 0.37; 0.21-0.66: p < .01), nurses' morning shift (OR 2.15; 1.10-4.18: p = .02) and workload perception (OR 3.64; 2.09-6.35: p < .01) were risk factors associated with interruption. CONCLUSIONS: Medication errors in prescription and administration were frequent. Timely detection of errors and promotion of a medication safety culture are necessary to reduce them and ensure the quality of care in critically ill patients. IMPACT: Medication errors occur frequently in the intensive care unit but are not always identified. Due to the vulnerability of seriously ill patients and the specialized care they require, an error can result in serious adverse events. The study shows that medication errors in prescription and administration are recurrent but preventable. These findings contribute to promote awareness in the proper use of medications and guarantee the quality of nursing care.

Pain, Anxiety, Depression, and Quality of Life in Patients with Vulvodynia.

BACKGROUND/AIMS: The term vulvodynia refers to vulvar pain of unknown origin lasting at least 3 months. Psychiatric comorbidities are a common feature and, along with pain, may severely affect patients' wellbeing. We aimed to determine the characteristics of pain in vulvodynia, to correlate characteristics with symptoms of anxiety and depression, and to analyse the impact of these factors on patients' quality of life. METHODS: This cross-sectional observational study analysed pain, anxiety, and depression and the effects of these factors on quality of life. Pain, anxiety, and depression were assessed using validated tools in 110 women. RESULTS: Statistical analyses found correlations between pain and anxiety and between anxiety and worsened quality of life. Patients often reported stinging, burning, pain, itching, and dyspareunia, pointing to the importance of temporal, localisation, punctate pressure, thermal, tactile sensitivity, and emotional tension characteristics. Most patients had severe pain related to psychiatric comorbidities and decreased quality of life. CONCLUSION: Using descriptors of pain quality and assessing anxiety and depression might help to define subgroups of patients that may benefit from different therapeutic approaches and thus enable treatments to be tailored to individual patients.

Quality of life and well-being from the perspective of patients on opioid agonist maintenance treatment: study protocol for a systematic review of qualitative research and a scoping review of measures.

BACKGROUND: Opioid agonist maintenance treatment (OAMT) is a first-line treatment for heroin dependence, but its effectiveness has been assessed primarily through clinical outcomes with a limited attention to patient perspectives. Despite the increased use of patient reported outcome measures their patient-centeredness is highly questionable. This is the protocol of a systematic review of qualitative research on how OAMT users construct the meaning of their quality of life and well-being and a scoping review of instruments that measure these domains. METHODS: We will conduct a systematic review of qualitative research exploring the views of quality of life of patients on OAMT (registration number CRD42018086490). According pre-specified eligibility criteria, we will include studies from a comprehensive search of bibliographical databases from their inception. We will extract data from included studies and assess their risk of bias with the CASP appraisal criteria, and will implement a thematic analysis to generate a set of interpretative analytical themes ascertaining their confidence using the CERQual approach. We will implement similar methods to conduct a scoping review to assess to what extent the existing measures of these domains were focused on user's views, assessing their validity using the COSMIN methodology, and summarizing their characteristics and level of patient centeredness. CONCLUSION: The findings from the reviews will contribute to obtain a genuine understanding of the perspective from users on OAMT regarding their perception of well-being and quality of life and will likely lead to greater patient centeredness when assessing such variables, which in turn may contribute to a more patient-centered care.

Pregunta estructurada para generar la búsqueda de una revisión sistemática / Structured question to generate search for a systematic review

No disponible

Pain distress: the negative emotion associated with procedures in ICU patients.

PURPOSE: The intensity of procedural pain in intensive care unit (ICU) patients is well documented. However, little is known about procedural pain distress, the psychological response to pain. METHODS: Post hoc analysis of a multicenter, multinational study of procedural pain. Pain distress was measured before and during procedures (0-10 numeric rating scale). Factors that influenced procedural pain distress were identified by multivariable analyses using a hierarchical model with ICU and country as random effects. RESULTS: A total of 4812 procedures were recorded (3851 patients, 192 ICUs, 28 countries). Pain distress scores were highest for endotracheal suctioning (ETS) and tracheal suctioning, chest tube removal (CTR), and wound drain removal (median [IQRs] = 4 [1.6, 1.7]). Significant relative risks (RR) for a higher degree of pain distress included certain procedures: turning (RR = 1.18), ETS (RR = 1.45), tracheal suctioning (RR = 1.38), CTR (RR = 1.39), wound drain removal (RR = 1.56), and arterial line insertion (RR = 1.41); certain pain behaviors (RR = 1.19-1.28); pre-procedural pain intensity (RR = 1.15); and use of opioids (RR = 1.15-1.22). Patient-related variables that significantly increased the odds of patients having higher procedural pain distress than pain intensity were pre-procedural pain intensity (odds ratio [OR] = 1.05); pre-hospital anxiety (OR = 1.76); receiving pethidine/meperidine (OR = 4.11); or receiving haloperidol (OR = 1.77) prior to the procedure. CONCLUSIONS: Procedural pain has both sensory and emotional dimensions. We found that, although procedural pain intensity (the sensory dimension) and distress (the emotional dimension) may closely covary, there are certain factors than can preferentially influence each of the dimensions. Clinicians are encouraged to appreciate the multidimensionality of pain when they perform procedures and use this knowledge to minimize the patient's pain experience.

Fentanyl as pre-emptive treatment of pain associated with turning mechanically ventilated patients: a randomized controlled feasibility study.

PURPOSE: To compare pain incidence and changes in pain scores with fentanyl versus placebo as pre-emptive treatment during turning and 30 min post-turning in mechanically ventilated critically ill patients. METHODS: We performed a randomized, double-blind, parallel-group, placebo-controlled clinical trial in the intensive care unit of a university hospital. Seventy-five mechanically ventilated patients were randomized to an intervention group (fentanyl) or a control group (placebo). Patients in the intervention group received 1 µg/kg (medical patients) or 1.5 µg/kg (surgical patients) of fentanyl 10 min before turning. Pain indicators were assessed using the behavioral pain scale. Safety was assessed by determining the frequency and severity of pre-defined adverse events. Pain was evaluated at rest (T0), at turn start and end (T1 and T2) and at 5, 15 and 30 min post-turning (T3, T4 and T5). RESULTS: The two groups had similar baseline characteristics. The area under the curve for BPS values was significantly smaller in the fentanyl group than in the control group [median and interquartile range (IQR): 132 (108-150) vs. 147 (125-180); p = 0.016, respectively]. Nineteen non-serious adverse events were recorded in 14 patients, with no significant between-group differences (23 % fentanyl group vs. 14 % control group; p = 0.381). CONCLUSIONS: These results suggest an intravenous bolus of fentanyl of 1 µg/kg for medical patients or 1.5 µg/kg for surgical patients reduces the incidence of turning-associated pain in critically ill patients on mechanical ventilation. ClinicalTrials.gov: NCT 01950000.

Postoperative Discomfort After Abdominal Surgery: An Observational Study.

PURPOSE: Patients who have surgery may experience distress in the following days. Although postoperative distress is a common experience, few studies have analyzed these patient complaints in-depth. The purpose of the present study was to analyze the potential causes of patients' discomfort after abdominal surgery. DESIGN: This was a prospective and observational study. METHODS: Patients (N = 131) were asked to rate their discomfort twice using a list of nine items in the first 6 to 8 hours after surgery and at 24 hours after its completion. Participants were asked to score intensity from 0 (absent) to 10 (unbearable). FINDINGS: The main causes of discomfort at 24 hours were pain (82%), movement restriction (79%), and dry mouth (70%). These items also had the highest scores (by gender, women scored higher than did men in insomnia, dry mouth, and abdominal distension). No significant differences were observed between patients who had undergone open or laparoscopic surgery. CONCLUSION: It was concluded that pain, movement restriction, and dry mouth were the most disturbing causes of discomfort. Therefore, symptoms other than pain should be considered to improve the well-being of patients after abdominal surgery.

A randomized controlled trial of fentanyl in the pre-emptive treatment of pain associated with turning in patients under mechanical ventilation: research protocol.

AIM: To compare the effectiveness and safety of fentanyl with placebo as pre-emptive treatment for pain associated with turning in patients in intensive care units. BACKGROUND: Turning is frequently a painful procedure in this setting. Pre-emptive administration of supplementary analgesia may help decrease this pain. However, medical literature on pre-emptive analgesia in these patients is scarce. DESIGN: A randomized, double-blind, controlled clinical trial. METHODS: This study will assess the benefits and risks of pre-emptive analgesia with fentanyl compared with placebo on turning-associated pain. Eighty patients will be recruited from among those older than 18 years and needing mechanical ventilation for at least 24 hours. Pain intensity will be assessed using the Behavioral Pain Scale. Primary outcome will be pain intensity between the baseline and 30 minutes after turning, measured by the area under the curve of the pain scale scores. Secondary outcomes will be the usefulness of physiological parameters and the Bispectral Index to measure pain and the safety of pre-emptive fentanyl in turning. The study protocol was approved in February 2011. DISCUSSION: If pre-emptive fentanyl is more effective than placebo and reasonably safe, the results of the current study may change nursing attitude in managing turning in critically ill patients. As a consequence, pain may be decreased during this nursing procedure.

Influence of preoperative emotional state on postoperative pain following orthopedic and trauma surgery.

OBJECTIVES: To analyze the relationship between preoperative emotional state and the prevalence and intensity of postoperative pain and to explore predictors of postoperative pain. METHOD: Observational retrospective study undertaken among 127 adult patients of orthopedic and trauma surgery. Postoperative pain was assessed with the verbal numeric scale and with five variables of emotional state: anxiety, sweating, stress, fear, and crying. The Chi-squared test, Student's t test or ANOVA and a multivariate logistic regression analysis were used for the statistical analysis. RESULTS: The prevalence of immediate postoperative pain was 28%. Anxiety was the most common emotional factor (72%) and a predictive risk factor for moderate to severe postoperative pain (OR: 4.60, 95% CI 1.38 to 15.3, p<0.05, AUC: 0.72, 95% CI: 0.62 to 0.83). Age exerted a protective effect (OR 0.96, 95% CI: 0.94-0.99, p<0.01). CONCLUSION: Preoperative anxiety and age are predictors of postoperative pain in patients undergoing orthopedic and trauma surgery.

Influence of preoperative emotional state on postoperative pain following orthopedic and trauma surgery / Influência do estado emocional pré-operatório na dor pós-operatória após cirurgias ortopédicas e traumatológicas / Influencia del estado emocional prequirúrgico en el dolor postoperatorio tras cirugía ortopédica y traumatológica

OBJECTIVES: to analyze the relationship between preoperative emotional state and the prevalence and intensity of postoperative pain and to explore predictors of postoperative pain. METHOD: observational retrospective study undertaken among 127 adult patients of orthopedic and trauma surgery. Postoperative pain was assessed with the verbal numeric scale and with five variables of emotional state: anxiety, sweating, stress, fear, and crying. The Chi-squared test, Student's t test or ANOVA and a multivariate logistic regression analysis were used for the statistical analysis. RESULTS: the prevalence of immediate postoperative pain was 28%. Anxiety was the most common emotional factor (72%) and a predictive risk factor for moderate to severe postoperative pain (OR: 4.60, 95% CI 1.38 to 15.3, p<0.05, AUC: 0.72, 95% CI: 0.62 to 0.83). Age exerted a protective effect (OR 0.96, 95% CI: 0.94-0.99, p<0.01). CONCLUSION: preoperative anxiety and age are predictors of postoperative pain in patients undergoing orthopedic and trauma surgery. .

OBJETIVOS: analisar a relação entre o estado emocional pré-operatório e a prevalência e a intensidade da dor pós-operatória e explorar fatores preditivos de dor pós-operatória. MÉTODO: estudo retrospectivo observacional, realizado com 127 pacientes adultos submetidos a cirurgias ortopédicas e traumatológicas. A dor pós-operatória foi avaliada usando a escala numérica verbal e cinco variáveis do estado emocional: ansiedade, sudorese, estresse, medo e choro. Para a análise estatística, foram utilizados os testes do qui-quadrado, teste t de Student ou análise de variância e uma análise de regressão logística multivariada. RESULTADOS: a prevalência de dor pós-operatória imediata foi de 28%. A ansiedade foi o fator emocional mais comum (72%) e fator preditivo de risco para dor pós-operatória severa (OR: 4,60, IC 95%: 1,38 a 15,3, p<0,05, AUC: 0,72, IC 95%: 0,62 a 0,83). A idade exerceu efeito protetor (OR 0,96, IC 95%: 0,94-0,99, p<0,01). CONCLUSÃO: a ansiedade pré-operatória e a idade são fatores preditivos de dor pós-operatória em pacientes submetidos a cirurgias ortopédicas e traumatológicas. .

OBJETIVOS: analizar la relación entre el estado emocional preoperatorio y la prevalencia e intensidad de dolor postoperatorio inmediato y explorar los factores predictivos de dolor postoperatorio. MÉTODO: estudio observacional y retrospectivo realizado a 127 pacientes adultos de cirugía ortopédica y traumatológica. El dolor postoperatorio se evaluó con la escala verbal numérica y el estado emocional con 5 variables: ansiedad, sudor, tensión, miedo, lloros. Para el análisis estadístico se utilizaron las pruebas de χ2, t de Student o ANOVA y un análisis multivariado con regresión logística. RESULTADOS: la prevalencia de dolor postoperatorio inmediato fue del 28%. La ansiedad fue el factor emocional más frecuente (72%) y un factor de riesgo predictivo para el dolor postoperatorio moderado-intenso (OR: 4,60, IC95%: 1,38-15,3, p<0,05; AUC: 0,72, IC95%: 0,62-0,83). La edad ejercía un efecto protector (OR: 0,96; IC95%: 0,94-0,99, p<0.01). CONCLUSIÓN: la ansiedad prequirúrgica y la edad son factores predictivos del dolor postoperatorio en pacientes sometidos a cirugía ortopédica y traumatológica. .

Determinants of procedural pain intensity in the intensive care unit. The Europain® study.

RATIONALE: Intensive care unit (ICU) patients undergo several diagnostic and therapeutic procedures every day. The prevalence, intensity, and risk factors of pain related to these procedures are not well known. OBJECTIVES: To assess self-reported procedural pain intensity versus baseline pain, examine pain intensity differences across procedures, and identify risk factors for procedural pain intensity. METHODS: Prospective, cross-sectional, multicenter, multinational study of pain intensity associated with 12 procedures. Data were obtained from 3,851 patients who underwent 4,812 procedures in 192 ICUs in 28 countries. MEASUREMENTS AND MAIN RESULTS: Pain intensity on a 0-10 numeric rating scale increased significantly from baseline pain during all procedures (P < 0.001). Chest tube removal, wound drain removal, and arterial line insertion were the three most painful procedures, with median pain scores of 5 (3-7), 4.5 (2-7), and 4 (2-6), respectively. By multivariate analysis, risk factors independently associated with greater procedural pain intensity were the specific procedure; opioid administration specifically for the procedure; preprocedural pain intensity; preprocedural pain distress; intensity of the worst pain on the same day, before the procedure; and procedure not performed by a nurse. A significant ICU effect was observed, with no visible effect of country because of its absorption by the ICU effect. Some of the risk factors became nonsignificant when each procedure was examined separately. CONCLUSIONS: Knowledge of risk factors for greater procedural pain intensity identified in this study may help clinicians select interventions that are needed to minimize procedural pain. Clinical trial registered with www.clinicaltrials.gov (NCT 01070082).