Hartley Garfield

The relationship between caregiver sensitivity and infant pain behaviors across the first year of life.

Summary Previous caregiver sensitivity and infant pain behaviour predict future sensitivity and behaviour in the immunization context, but consistent interrelationships are not seen until 12 months of age. ABSTRACT Recent research has begun to examine discrete caregiver pain management behaviors in the infant immunization context. However, there is a dearth of research exploring more global caregiving constructs, such as emotional availability, which can be used to examine the overall sensitivity of caregiver pain management. The aim of the present study was to examine the relationships between caregiver sensitivity (emotional availability) and infant pain behavior (baseline, immediately post‐needle, 1 min after needle) over the first year of life. Parents and infants were a part of a Canadian longitudinal cohort (the Opportunities to Understand Childhood Hurt or OUCH cohort) followed up during their 2‐, 4‐, 6‐, and 12‐month immunizations (current n = 731). Both within‐age group analyses and over‐age analyses were performed. Results indicated that: (1) over age, previous infant pain behavior predicts future infant pain behavior, but this varied depending on timing of pain response and age of infant; (2) over age, previous caregiver sensitivity strongly predicts future caregiver sensitivity; and (3) the concurrent relationship between caregiver sensitivity and every type of infant pain response is only consistently seen at the 12‐month immunization. Caregiver sensitivity to the infant in pain is predicted most reliably from previous caregiver sensitivity, not infant pain behaviour. The significant concurrent relationship between caregiver sensitivity and infant pain behaviours is not seen until 12 months, replicating patterns in the infant development literature regarding the time at which the attachment relationship between parent and child can be reliably measured. Discussion addresses implications for both researchers and clinicians who work with infants in pain.

Variability in infant acute pain responding meaningfully obscured by averaging pain responses

Summary Stable variability in infant pain responses increases with age, challenging the validity of using a mean infant pain score in pain research. Abstract Given the inherent variability in pain responding, using an “average” pain score may pose serious threats to internal and external validity. Using growth mixture modeling (GMM), this article first examines whether infants can be differentiated into stable groups based on their pain response patterns over a 2‐minute post‐needle period. Secondary analyses, to specifically address the issue of averaging pain scores to represent a sample, qualitatively described clinically meaningful differences between pain scores of the discerned groups and the overall mean (irrespective of groups). Infants were part of Canadian longitudinal cohort naturalistically observed during their 2‐, 4‐, 6‐, and/or 12‐month immunization appointments (N = 458 to 574) at 3 pediatrician clinics between 2007 and 2012. At every age, GMM analyses discerned distinct groups of infants with significantly variable patterns of pain responding over the 2 minutes post‐needle. Our secondary suggested that the overall mean pain score immediately post‐needle reflected most groups well at every age. However, for older infants (6 and 12 months, especially), the overall mean pain responses at 1 and 2 minutes post‐needle significantly over or underestimated groups that contained 48% to 100% of the sample. These results combined highlight the significant variability of infant pain responding patterns between groups of infants and furthermore, calls into question the validity of using an overall mean in research with older infants during the regulatory phase post‐needle.

Naturalistic parental pain management during immunizations during the first year of life: Observational norms from the OUCH cohort

&NA; Descriptive information about pain management techniques used in infant immunizations is provided. The relationship between these techniques and infant pain is also examined. &NA; No research to date has descriptively catalogued what parents of healthy infants are naturalistically doing to manage their infant’s pain over immunization appointments during the first year of life. This knowledge, in conjunction with an understanding of the relationships different parental techniques have with infant pain‐related distress, would be useful when attempting to target parental pain management strategies in the infant immunization context. This study presents descriptive information about the pain management techniques parents have chosen and examines the relationships these naturalistic techniques have with infant pain‐related distress during the first year of life. A total of 760 parent‐infant dyads were recruited from 3 pediatric clinics in Toronto, ON, Canada, and were naturalistically followed and videotaped longitudinally over 4 immunization appointments during the infant’s first year of life. Infants were full‐term, healthy babies. Videotapes were subsequently coded for infant pain‐related distress behaviors and parental pain management techniques. After controlling for preceding infant pain‐related distress levels, parent pain management techniques accounted for, at most, 13% of the variance in infant pain‐related distress scores. Across all age groups, physical comfort, rocking, and verbal reassurance were the most commonly used nonpharmacological pain management techniques. Pacifying and distraction appeared to be most promising in reducing needle‐related distress in our sample of healthy infants. Parents in this sample seldom used pharmacological pain management techniques. Given the psychological and physical repercussions involved with unmanaged repetitive acute pain and the paucity of work in healthy infants, this paper highlights key areas for improving parental pain management in primary care.

A Longitudinal Examination of Verbal Reassurance During Infant Immunization: Occurrence and Examination of Emotional Availability as a Potential Moderator

OBJECTIVE This study investigated the associations between caregiver verbal reassurance and infant pain-related distress during immunization over the first year of life. The relationships between verbal reassurance and caregiver emotional availability (EA) were also examined. Finally, EA was investigated as a moderator of the relationship between verbal reassurance and infant pain. METHODS A cross-sectional analysis was conducted with 606 infants (and their parents) at 4 different ages (n = 376 at 2 months, n = 455 at 4 months, n = 484 at 6 months, and n = 407 at 12 months). RESULTS Verbal reassurance was positively associated with infant distress across all four ages. EA was only negatively related to verbal reassurance at 12 months of age. EA was not a significant moderator at any age. CONCLUSION Findings demonstrate consistent but small relationships between verbal reassurance and infant pain over the first year of life.

A cross-sectional examination of the relationships between caregiver proximal soothing and infant pain over the first year of life.

&NA; In a longitudinal cohort of 760 caregiver–infant dyads, earlier infant pain behaviour was a stronger predictor of later infant pain responding than caregiver proximal soothing. &NA; Although previous research has examined the relationships between caregiver proximal soothing and infant pain, there is a paucity of work taking infant age into account, despite the steep developmental trajectory that occurs across the infancy period. Moreover, no studies have differentially examined the relationships between caregiver proximal soothing and initial infant pain reactivity and pain regulation. This study examined how much variance in pain reactivity and pain regulation was accounted for by caregiver proximal soothing at 4 routine immunizations (2, 4, 6, and 12 months) across the first year of life, controlling for preneedle distress. One latent growth model was replicated at each of the 4 infant ages, using a sample of 760 caregiver–infant dyads followed longitudinally. Controlling for preneedle infant distress, caregiver proximal soothing accounted for little to no variance in infant pain reactivity or regulation at all 4 ages. Preneedle distress and pain reactivity accounted for the largest amount of variance in pain regulation, with this increasing after 2 months. It was concluded that within each immunization appointment across the first year of life, earlier infant pain behaviour is a stronger predictor of subsequent infant pain behaviour than caregiver proximal soothing. Given the longer‐term benefits that have been demonstrated for proximal soothing during distressing contexts, caregivers are still encouraged to use proximal soothing during infant immunizations.

Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6–35 Months: A Randomized, Controlled Trial

Background. Improved influenza vaccine strategies for infants and preschool children are a high priority. Methods. The immunological response and safety of a thimerosal-free trivalent inactivated influenza vaccine at 2 different doses (0.50 mL vs 0.25 mL) was evaluated in children aged 6–35 months. The study was randomized, observer blind, multicenter, and stratified by age (6–23 months and 24–35 months), and it accounted for prior influenza immunization status. Results. Three hundred seventy-four children were in the total vaccinated cohort (study vaccine 0.25-mL dose, n = 164; 0.50-mL dose, n = 167; comparator 0.25 mL, n = 43). Regulatory criteria for immunogenicity of influenza vaccines in adults were met for all virus strains and doses for both age strata. A modest but not statistically significant improvement in immune responses was observed with the higher dose and reactogenicity, and safety of the 2 doses was not significantly different. Conclusions. The 0.5-mL dose of the study vaccine, when administered to children aged 6–35 months, resulted in a modest but not statistically significant improvement in immunogenicity with clinically similar safety and reactogenicity compared with the 0.25-mL dose. Further studies comparing full- and half-dose influenza vaccine in young children are needed. Clinical Trials Registration. NCT00778895.

Randomized, multicenter trial of a single dose of AS03-adjuvanted or unadjuvanted H1N1 2009 pandemic influenza vaccine in children 6 months to <9 years of age: safety and immunogenicity.

Background: During the 2009–2010 influenza pandemic, we evaluated the immunogenicity and safety of different H1N1 2009 pandemic influenza vaccines delivering various viral hemagglutinin (HA) doses with or without AS03 (a tocopherol oil-in-water emulsion–based adjuvant system) in children (NCT00976820). Methods: Three hundred twenty-two healthy children 6 months to <9 years of age were randomized to receive 2 doses of nonadjuvanted (15 µg or 7.5 µg HA) or adjuvanted vaccine (3.75 µg HA/AS03A or 1.9 µg HA/AS03B), 21 days apart. Blood samples before and after each dose were tested for immune responses using hemagglutination inhibition and microneutralization assays. Safety assessments were done up to day 385. Results: The first dose of both AS03-adjuvanted vaccines elicited strong immune responses (seroprotection rates: 98.3%/99.0%; seroconversion rates: 94.9%/97.0%; geometric mean fold rises: 36.2/33.6), which were higher post-dose 2 (seroprotection rate: 100.0%/100%; seroconversion rate: 100.0%/98.8%; geometric mean fold rise: 157.1/151.6), meeting European regulatory criteria on days 21 and 42. The nonadjuvanted 15 µg HA vaccine also met the regulatory criteria after each dose; the 7.5 µg HA vaccine met them only post-dose 2. Six months post-dose 1, all vaccines except the nonadjuvanted 7.5 µg HA vaccine met European regulatory criteria. Neutralizing antibody response paralleled the hemagglutination inhibition immune response after each dose. Pain at the injection site, lasting 2–3 days, was more common following adjuvanted than nonadjuvanted vaccination. Conclusions: AS03-adjuvanted H1N1 2009 pandemic influenza vaccine (3.75 µg or 1.9 µg HA), administered as 2 doses, was highly immunogenic, induced long-term immune response to 6 months, with a clinically acceptable safety profile in children aged 6 months to <9 years of age.

Predicting preschool pain-related anticipatory distress: the relative contribution of longitudinal and concurrent factors.

Abstract Anticipatory distress prior to a painful medical procedure can lead to negative sequelae including heightened pain experiences, avoidance of future medical procedures, and potential noncompliance with preventative health care, such as vaccinations. Few studies have examined the longitudinal and concurrent predictors of pain-related anticipatory distress. This article consists of 2 companion studies to examine both the longitudinal factors from infancy as well as concurrent factors from preschool that predict pain-related anticipatory distress at the preschool age. Study 1 examined how well preschool pain-related anticipatory distress was predicted by infant pain response at 2, 4, 6, and 12 months of age. In study 2, using a developmental psychopathology framework, longitudinal analyses examined the predisposing, precipitating, perpetuating, and present factors that led to the development of anticipatory distress during routine preschool vaccinations. A sample of 202 caregiver–child dyads was observed during their infant and preschool vaccinations (the Opportunities to Understand Childhood Hurt cohort) and was used for both studies. In study 1, pain response during infancy was not found to significantly predict pain-related anticipatory distress at preschool. In study 2, a strong explanatory model was created whereby 40% of the variance in preschool anticipatory distress was explained. Parental behaviours from infancy and preschool were the strongest predictors of child anticipatory distress at preschool. Child age positively predicted child anticipatory distress. This strongly suggests that the involvement of parents in pain management interventions during immunization is one of the most critical factors in predicting anticipatory distress to the preschool vaccination.

The role of infant pain behaviour in predicting parent pain ratings

Health care practitioners rely heavily on parents’ ratings of their infants’ pain, and parents are largely responsible for managing the pain experienced by their infants during and after immunization. However, parents’ pain ratings are known to be influenced by characteristics specific to the parents. Accordingly, this study analyzed the magnitude of parents’ rating of their infant’s pain that is due to actual pain behaviours of the neonate rather than parent characteristics during multiple immunizations in a cohort of 747 infants.

Preschool childrenʼs coping responses and outcomes in the vaccination context: child and caregiver transactional and longitudinal relationships

Abstract This article, based on 2 companion studies, presents an in-depth analysis of preschoolers coping with vaccination pain. Study 1 used an autoregressive cross-lagged path model to investigate the dynamic and reciprocal relationships between young childrens coping responses (how they cope with pain and distress) and coping outcomes (pain behaviors) at the preschool vaccination. Expanding on this analysis, study 2 then modeled preschool coping responses and outcomes using both caregiver and child variables from the childs 12-month vaccination (n = 548), preschool vaccination (n = 302), and a preschool psychological assessment (n = 172). Summarizing over the 5 path models and post hoc analyses over the 2 studies, novel transactional and longitudinal pathways predicting preschooler coping responses and outcomes were elucidated. Our research has provided empirical support for the need to differentiate between coping responses and coping outcomes: 2 different, yet interrelated, components of “coping.” Among our key findings, the results suggest that a preschoolers ability to cope is a powerful tool to reduce pain-related distress but must be maintained throughout the appointment; caregiver behavior and poorer pain regulation from the 12-month vaccination appointment predicted forward to preschool coping responses and/or outcomes; robust concurrent relationships exist between caregiver behaviors and both child coping responses and outcomes, and finally, caregiver behaviors during vaccinations are not only critical to both child pain coping responses and outcomes in the short- and long-term but also show relationships to broader child cognitive abilities as well.