Featured Article: The ABCDs of Pain Management: A Double-Blind Randomized Controlled Trial Examining the Impact of a Brief Educational Video on Infants' and Toddlers' Pain Scores and Parent Soothing Behavior.

Objectives: To test the efficacy of a brief behavioral pain management strategy (The ABCDs of Needle Pain Management), delivered via video, on infants' and toddlers' pain scores and on parental soothing behavior. Methods: This was a double-blind, parallel trial design. Parent-child dyads (N = 128) were recruited before their child's 6-month (infant) or 18-month (toddler) vaccination in a pediatric clinic and randomly assigned to watch a 5-min treatment video or a placebo video. The primary outcome was the Modified Behavior Pain Scale (Taddio et al., Journal of Pain and Symptom Management, 10, pp. 456-463, 1995), coded during four epochs (Pain Reactivity, Pain Regulation 1 min, Pain Regulation 2 min, and Pain Regulation 3 min) after the last vaccination needle. Secondary analyses examined parental use of distraction, rocking, and physical comforting over this same time period. Results: Results demonstrated a treatment effect for toddlers (18-month-olds) for the Pain Regulation 1 (d = 0.84) and Pain Regulation 2 (d = 0.76) postvaccination scores. Secondary analyses found differences in parental rocking and physical comforting between treatment conditions and between age-groups (d's = 0.37-0.54). Conclusions: The ABCD pain management strategy delivered via video was an effective way to reduce toddler pain after vaccination and increase parental use of rocking and physical comforting. The treatment effect was not demonstrated with infants.

Relative effectiveness of additive pain interventions during vaccination in infants.

BACKGROUND: Vaccine injections can cause acute pain and distress in infants, which can contribute to dissatisfaction with the vaccination experience and vaccine hesitancy. We sought to compare the effectiveness of additive pain interventions administered consistently during vaccine injections in the first year of life. METHODS: We conducted a multicentre, longitudinal, double-blind, add-on, randomized controlled trial. Healthy infants were randomly assigned to 1 of 4 levels of pain management for all vaccine injections at 2, 4, 6 and 12 months: (i) placebo control; (ii) parent-directed video education about infant soothing; (iii) the video plus sucrose administered orally or (iv) the video plus sucrose plus liposomal lidocaine applied topically. All infants benefit from injection techniques that minimize pain. We used a double-dummy design; hence all parents watched a video (active psychological intervention or placebo) and all infants received oral solution (sucrose or placebo) and topical cream (lidocaine or placebo). We assessed infant distress during 3 phases - preinjection (baseline), vaccine injection (needle), and 1 minute postinjection (recovery) - using the Modified Behavioural Pain Scale (range 0-10). We compared scores between groups and across infant ages using a mixed-model repeated-measures analysis. RESULTS: A total of 352 infants participated in the study, from Jan. 17, 2012, to Feb. 2, 2016. Demographics did not differ among intervention groups (p > 0.05). Baseline pain scores did not differ among intervention groups (p = 0.4), but did differ across ages (p < 0.001). Needle pain scores differed among groups (p = 0.003) and across ages (p < 0.001). The mean (± standard deviation) needle score was 6.3 (± 0.8) in the video-sucrose-lidocaine group compared with 6.7 (± 0.8) in each of the other groups. There were no other between-group differences. Recovery scores did not differ among groups (p = 0.98), but did differ across ages (p < 0.001). INTERPRETATION: Only liposomal lidocaine provided consistent analgesia within an additive pain intervention regimen during vaccinations in infants. Trial registration: ClinicalTrials.gov, no. NCT01503060.

Systematic Review: A Systematic Review of the Interrelationships Among Children's Coping Responses, Children's Coping Outcomes, and Parent Cognitive-Affective, Behavioral, and Contextual Variables in the Needle-Related Procedures Context.

Objective: To conduct a systematic review of the interrelationships between children's coping responses, children's coping outcomes, and parent variables during needle-related procedures. A systematic literature search was conducted. It was required that the study examined a painful needle-related procedure in children from 3 to 12 years of age, and included a children's coping response, a children's coping outcome, and a parent variable. In all, 6,081 articles were retrieved to review against inclusion criteria. Twenty studies were included. Parent coping-promoting behaviors and distress-promoting behaviors enacted in combination are the most consistent predictors of optimal children's coping responses, and less optimal children's coping outcomes, respectively. Additional key findings are presented. Children's coping with needle-related procedures is a complex process involving a variety of different dimensions that interact in unison. Parents play an important role in this process. Future researchers are encouraged to disentangle coping responses from coping outcomes when exploring this dynamic process.

Usability and knowledge testing of educational tools about infant vaccination pain management directed to postnatal nurses.

BACKGROUND: Adapting educational tools to meet user needs is a critical aspect of translating research evidence into best clinical practices. The objectives of this study were to evaluate usability and effectiveness of educational tools about infant vaccination pain management directed to postnatal nurses. METHODS: Mixed methods design. A template pamphlet and video included in a published clinical practice guideline were subjected to heuristic usability evaluation and then the revised tools were reviewed by postnatal hospital nurses in three rounds of interviews involving 8 to 12 nurses per round. Nurses' knowledge about evidence-based pain management interventions was evaluated at three time points: baseline, after pamphlet review, and after video review. RESULTS: Of 32 eligible postnatal nurses, 29 agreed to participation and data were available for 28. Three overarching themes were identified in the interviews: 1) utility of information, 2) access to information, and 3) process for infant procedures. Nurses' knowledge improved significantly (p < 0.05) from the baseline phase to the pamphlet review phase, and again from the pamphlet review phase to the video review phase. CONCLUSIONS: This study demonstrated usability and knowledge uptake from a nurse-directed educational pamphlet and video about managing infant vaccination pain. Future studies are needed to determine the impact of implementing these educational tools in the postnatal hospital setting on parental utilization of analgesic interventions during infant hospitalization and future infant vaccinations.

A randomized waitlist control trial of the Make the Connection® online program for caregivers of infants and young children: Study protocol.

Background: A positive child-caregiver relationship is one of the strongest determinants of child health and development, yet many caregivers report challenges in establishing a positive relationship with their child. For over 20 years, Make the Connection® (MTC), an evidence-based parenting program, has been delivered in-person by child-caring professionals to over 120,000 parents to improve positive parenting behaviours and attitudes. Recently, MTC has been adapted into a 'direct to caregiver' online platform to increase scalability and accessibility. The purpose of this study is to evaluate the effectiveness of the online modality of MTC in increasing parenting knowledge, attitudes, and the perceived relationship with their child, and to understand barriers and facilitators to its access. Methods: Two hundred caregivers with children aged 0-3 years old will be recruited through Public Health agencies in Ontario, Canada. Participants will be randomly placed in the intervention or waitlist control group. Both groups will complete a battery of questionnaires at study enrolment and 8 weeks later. The intervention group will receive the MTC online program during the 8-week period, while the waitlist group will receive the program after an 8-week wait. The study questionnaires will address demographic information, caregivers' relational attitudes towards their infant, self-competence in their caregiver role, depression, and caregiver stress, as well as caregivers' and infants' emotion regulation. Discussion: Results from this study will add critical knowledge to the development, scaling, and roll out of the MTC online program, thus increasing its capacity to reach a greater number of families. Trial registration: The study was registered with ClinicalTrials.gov on 15 March 2023 (NCT05770414).

Health Care Professionals' and Parents' Perspectives on the Use of AI for Pain Monitoring in the Neonatal Intensive Care Unit: Multisite Qualitative Study.

BACKGROUND: The use of artificial intelligence (AI) for pain assessment has the potential to address historical challenges in infant pain assessment. There is a dearth of information on the perceived benefits and barriers to the implementation of AI for neonatal pain monitoring in the neonatal intensive care unit (NICU) from the perspective of health care professionals (HCPs) and parents. This qualitative analysis provides novel data obtained from 2 large tertiary care hospitals in Canada and the United Kingdom. OBJECTIVE: The aim of the study is to explore the perspectives of HCPs and parents regarding the use of AI for pain assessment in the NICU. METHODS: In total, 20 HCPs and 20 parents of preterm infants were recruited and consented to participate from February 2020 to October 2022 in interviews asking about AI use for pain assessment in the NICU, potential benefits of the technology, and potential barriers to use. RESULTS: The 40 participants included 20 HCPs (17 women and 3 men) with an average of 19.4 (SD 10.69) years of experience in the NICU and 20 parents (mean age 34.4, SD 5.42 years) of preterm infants who were on average 43 (SD 30.34) days old. Six themes from the perspective of HCPs were identified: regular use of technology in the NICU, concerns with regard to AI integration, the potential to improve patient care, requirements for implementation, AI as a tool for pain assessment, and ethical considerations. Seven parent themes included the potential for improved care, increased parental distress, support for parents regarding AI, the impact on parent engagement, the importance of human care, requirements for integration, and the desire for choice in its use. A consistent theme was the importance of AI as a tool to inform clinical decision-making and not replace it. CONCLUSIONS: HCPs and parents expressed generally positive sentiments about the potential use of AI for pain assessment in the NICU, with HCPs highlighting important ethical considerations. This study identifies critical methodological and ethical perspectives from key stakeholders that should be noted by any team considering the creation and implementation of AI for pain monitoring in the NICU.

Knowledge translation of the HELPinKIDS clinical practice guideline for managing childhood vaccination pain: usability and knowledge uptake of educational materials directed to new parents.

BACKGROUND: Although numerous evidence-based and feasible interventions are available to treat pain from childhood vaccine injections, evidence indicates that children are not benefitting from this knowledge. Unrelieved vaccination pain puts children at risk for significant long-term harms including the development of needle fears and subsequent health care avoidance behaviours. Parents report that while they want to mitigate vaccination pain in their children, they lack knowledge about how to do so. An evidence-based clinical practice guideline for managing vaccination pain was recently developed in order to address this knowledge-to-care gap. Educational tools (pamphlet and video) for parents were included to facilitate knowledge transfer at the point of care. The objectives of this study were to evaluate usability and effectiveness in terms of knowledge acquisition from the pamphlet and video in parents of newly born infants. METHODS: Mixed methods design. Following heuristic usability evaluation of the pamphlet and video, parents of newborn infants reviewed revised versions of both tools and participated in individual and group interviews and individual knowledge testing. The knowledge test comprised of 10 true/false questions about the effectiveness of various pain management interventions, and was administered at three time points: at baseline, after review of the pamphlet, and after review of the video. RESULTS: Three overarching themes were identified from the interviews regarding usability of these educational tools: receptivity to learning, accessibility to information, and validity of information. Parents' performance on the knowledge test improved (p≤0.001) from the baseline phase to after review of the pamphlet, and again from the pamphlet review phase to after review of the video. CONCLUSIONS: Using a robust testing process, we demonstrated usability and conceptual knowledge acquisition from a parent-directed educational pamphlet and video about management of vaccination pain. Future studies are planned to determine the impact of these educational tools when introduced in clinical settings on parent behaviors during infant vaccinations.

Caregiver and Young Child Biological Attunement In Distress Contexts: A Systematic Review and Narrative Synthesis.

The objective of the current study was to systematically review the literature on caregiver-child biological attunement within distress contexts during the first three years of life. A total of 9932 unique abstracts were identified through Medline, Embase, PsycINFO, CINAHL, and Scopus databases. Thirty-six studies provided data from caregivers and their infants or toddlers within a distress paradigm, used biological indicators of distress, and assessed the relations between caregiver and child biological indicators. Findings were synthesized based on biological indicators, type of analysis, and measurement epochs pre- and post-distress. Most articles examined cortisol. Associations between caregiver and child cortisol indicators were moderate to large, though findings varied depending on the analysis used and measurement epochs examined. Many of the findings examining relations between mother and child cardiac, sAA, and EEG indicators were weak or inconsistent, likely due to the limitations of methodological approaches used to capture the complexity of the caregiver-child attunement process. Gaps in the literature and suggestions for future research are discussed.

The influence of culture on maternal soothing behaviours and infant pain expression in the immunization context.

OBJECTIVE: To investigate how maternal culture (ie, individualist versus collectivist) influences soothing techniques and infant distress. METHODS: Archival data were analyzed using a subsample of 80 motherinfant dyads selected from a larger database of infant pain expression. RESULTS: Mothers belonging to the individualist group used more affection behaviours when attempting to regulate their infants' distress. No differences were observed in mothers' touching, holding, rocking, vocalizing, caregiving or distracting their infants. Mothers' culture did not appear to be related to the level of distress expressed by their infants. CONCLUSIONS: These results suggest that the similarities in soothing and infant pain expression between individualist and collectivist cultures are more prominent than their differences.

Understanding Stability and Change in Perceived Social Support in Parents of Autistic Children and Adolescents.

Parents of children with autism often have their own support needs. Informal social support can be an important component of managing parenting-related stressors. We know very little about the factors that lead to higher levels of perceived social support or the potential reciprocal relationship social support has with other factors in parents of children with autism. The current longitudinal study examined the reciprocal relations of perceived social support and parent stress and child behavior problems across a 1-year period, using three time points. There was remarkable stability in variables over time. Baseline perceived social support significantly predicted changes in child behavior and parent stress at the 6-month time point, but neither of those variables significantly predicted social support. This study adds to our understanding of social support and clarifies how perceived social support relates to other factors longitudinally.

Distress Responses in a Routine Vaccination Context: Relationships to Early Childhood Mental Health.

Social and emotional competencies, such as distress regulation, are established in early childhood and are critical for the development of children's mental health and wellbeing. Routine vaccinations in primary care provide a unique opportunity to relate responses to a universal, relatively standardized, distress regulation paradigm (i.e., pain-related distress) to key developmental outcomes. The current study sought to examine distress regulation during routine vaccination in infancy and preschool as predictors of outcomes related to socioemotional competence in preschool. It was hypothesized that children with poorer distress regulation abilities post-vaccination would have lower socioemotional development. Furthermore, it was hypothesized that insensitive parenting would exacerbate this relationship for children with poor distress regulation abilities. As part of an ongoing longitudinal cohort, 172 parent-child dyads were videotaped during vaccinations in infancy and preschool, and subsequently participated in a full-day psychological assessment in a university lab. Videotapes were coded for child pre-needle distress (baseline distress), immediate post-needle pain-related distress reactivity (immediate distress reactivity), and pain-related distress regulation (distress regulation). Parent sensitivity during the preschool vaccination was also coded. Baseline distress prior to vaccination predicted greater externalizing problems and behavioral symptoms. Parent sensitivity did not moderate the association between any child distress behaviors and socioemotional development indicators. Child distress behaviors prior to injection, regardless of parent behavior, during the vaccination context may provide valuable information to health care professionals about child socioemotional functioning in the behavioral and emotional domains.

Understanding the Relative Contributions of Sensitive and Insensitive Parent Behaviors on Infant Vaccination Pain.

Parents play a critical role in supporting infants' ability to manage strong emotions. Routine vaccinations provide an ideal context to observe the effect of parents' behaviors on infants' pain-related distress. Previous research in the vaccination context showed that parent sensitivity, operationalized by variables such as emotional availability and proximal soothing behaviors, is associated with infant pain-related distress behavior. However, the magnitudes of these relationships were smaller than expected given the established importance of parents in the development of distress regulation. In recent work, a reliable and valid measure to operationalize insensitive behaviors was developed. The objective of the current study was to examine the relative contribution of variables representing sensitive and insensitive behaviors to the prediction of infant pain-related distress behaviors during the reactivity and regulation phases of needle pain. Archival data was used to analyze a subsample of infants followed during their two-month, six-month, and 12-month vaccinations (n= 81). Results of regression analyses indicated that parent insensitive behaviors generally had the strongest relationships with pain outcomes across all ages, with a greater influence on regulation-phase pain-related distress behavior, rather than reactivity-phase pain-related distress behavior. Our findings support the utility of a measure of distress-promoting parent behaviors in a vaccination context, and highlight the potential value of this measure for clinicians and researchers.

A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress.

The objective was to determine if consistent pain management during vaccine injections has a beneficial effect on future infant pain reactivity. This was a multicenter, longitudinal, double-blind, double-dummy, add-on, randomized controlled trial. Healthy infants were randomized to 1 of 4 add-on pain management regimens for all vaccinations in the first year of life: 1) placebo control (standard care), 2) parent video education about infant soothing (video), 3) video and oral sucrose solution (sucrose), 4) video and sucrose and topical liposomal lidocaine (lidocaine). At 15-month vaccinations, all active pain interventions were administered (video and sucrose and lidocaine); however, individuals remained blinded to the original treatments given. Pain at 15 months was evaluated during 3 procedure phases (baseline, needle injection, and recovery) by a researcher unaware of group allocation using a validated measure, the Modified Behavioural Pain Scale (range, 0-10). Altogether, 352 infants participated; characteristics did not differ among groups (P > .05). Pain scores did not differ among groups during baseline (P = .642), needle injection (P = .739), or recovery (P = .750) phases. In conclusion, there was no evidence of a long-term benefit of consistent use of pain interventions in the first year of life on future infant pain responsivity at 15-month vaccinations. PERSPECTIVE: This randomized controlled trial did not find a long-term benefit of consistent pain management during infant vaccinations on future infant pain responsivity at 15 months. The results are relevant to clinicians and researchers studying and evaluating pain interventions in children undergoing medical procedures.

Distress regulation in infancy: attachment and temperament in the context of acute pain.

OBJECTIVE: The relationship between attachment, temperamental fear, and pain-related distress was examined in a sample of 130 caregiver-infant dyads to explore the differential susceptibility hypothesis. METHOD: Infant distress was measured during routine immunization at 12 months, and attachment and temperamental fear were measured at 12 to 18 months (meanage = 13.74, SD = 1.35) using the Strange Situation Procedure and parent-rated Infant Behavior Questionnaire-Revised, respectively. RESULTS: Immediately before immunization, avoidant infants exhibited significantly less distress than secure infants. Temperamental fear moderated the relationship between attachment and regulation; under conditions of high temperamental fear, avoidant infants regulated distress more slowly than secure infants, whereas under conditions of low temperamental fear, secure infants regulated distress more slowly than avoidant and disorganized infants. CONCLUSION: The findings suggest that attachment interacts with extremes in temperamental fear to produce differences in the regulation of distress. The results partially support the differential susceptibility hypothesis.

Interventions for Individuals With High Levels of Needle Fear: Systematic Review of Randomized Controlled Trials and Quasi-Randomized Controlled Trials.

BACKGROUND: This systematic review evaluated the effectiveness of exposure-based psychological and physical interventions for the management of high levels of needle fear and/or phobia and fainting in children and adults. DESIGN/METHODS: A systematic review identified relevant randomized and quasi-randomized controlled trials of children, adults, or both with high levels of needle fear, including phobia (if not available, then populations with other specific phobias were included). Critically important outcomes were self-reported fear specific to the feared situation and stimulus (psychological interventions) or fainting (applied muscle tension). Data were pooled using standardized mean difference (SMD) or relative risk with 95% confidence intervals. RESULTS: The systematic review included 11 trials. In vivo exposure-based therapy for children 7 years and above showed benefit on specific fear (n=234; SMD: -1.71 [95% CI: -2.72, -0.7]). In vivo exposure-based therapy with adults reduced fear of needles posttreatment (n=20; SMD: -1.09 [-2.04, -0.14]) but not at 1-year follow-up (n=20; SMD: -0.28 [-1.16, 0.6]). Compared with single session, a benefit was observed for multiple sessions of exposure-based therapy posttreatment (n=93; SMD: -0.66 [-1.08, -0.24]) but not after 1 year (n=83; SMD: -0.37 [-0.87, 0.13]). Non in vivo e.g., imaginal exposure-based therapy in children reduced specific fear posttreatment (n=41; SMD: -0.88 [-1.7, -0.05]) and at 3 months (n=24; SMD: -0.89 [-1.73, -0.04]). Non in vivo exposure-based therapy for adults showed benefit on specific fear (n=68; SMD: -0.62 [-1.11, -0.14]) but not procedural fear (n=17; SMD: 0.18 [-0.87, 1.23]). Applied tension showed benefit on fainting posttreatment (n=20; SMD: -1.16 [-2.12, -0.19]) and after 1 year (n=20; SMD: -0.97 [-1.91, -0.03]) compared with exposure alone. CONCLUSIONS: Exposure-based psychological interventions and applied muscle tension show evidence of benefit in the reduction of fear in pediatric and adult populations.