Community pharmacists' perceptions of the CARD (Comfort Ask Relax Distract) system for use during vaccinations.

Introduction: We explored Canadian community pharmacists' perceptions of the CARD (Comfort Ask Relax Distract) system, a vaccine delivery framework that integrates evidence-based interventions that reduce immunization stress-related responses (ISRRs). The objective was to introduce CARD to pharmacists and obtain their feedback to guide future implementation efforts for community pharmacy-based vaccinations. Methods: Eighteen pharmacists across all provinces participated in one-on-one moderated virtual interviews. A semistructured interview guide was used to guide the discussion and included questions about experiences with coronavirus disease 2019 (COVID-19) vaccine administration and perceptions of CARD as a framework for vaccination delivery in the pharmacy. In this report, we focus on feedback about CARD. Interviews were audio-recorded and transcribed verbatim and deductively coded using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted from May 28 to August 16, 2021. Pharmacists' responses were categorized in 3 CFIR domains: intervention characteristics, inner setting and characteristics of individuals. Overall, pharmacists were receptive towards CARD and thought it filled a current gap in practice, particularly for childhood vaccinations. Pharmacists reported learning techniques to make vaccinations more comfortable for their clients. They provided feedback on how specific interventions could be adapted for their practice (e.g., dissemination of client-directed education via appointment booking portals, provision of distraction items in waiting and vaccinating spaces). Discussion: This study provided preliminary evidence that pharmacists found CARD acceptable and appropriate for community pharmacy-based vaccinations. The data collected from this study were used to inform a small-scale implementation project with CARD during COVID-19 vaccine administration in children aged 5 to 11 years.

Experiences of community pharmacists administering COVID-19 vaccinations: A qualitative study.

Background: Throughout the COVID-19 pandemic, community pharmacists have played an important role in the provision of patient care, including the delivery of COVID-19 vaccines. The additional workload and related demands arising from these extended services might affect worklife burnout. This qualitative study explored the experiences of Canadian community pharmacists in providing COVID-19 vaccines during the COVID-19 pandemic. Methods: Eighteen community pharmacists across 10 provinces were asked about vaccination processes and perceptions about their role in separate, virtual semistructured interviews. Interviews were transcribed verbatim and analyzed using a deductive approach using the Areas of Worklife Burnout framework, with pharmacists' self-reported descriptions of their activities summarized using the Association of Faculties of Pharmacy of Canada's (AFPC) professional competencies framework. Results: Participants identified aspects of their role that were rewarding and challenging. Some challenges included lack of control, increased workload, inadequate communication, unfair treatment and conflicting values. They described being able to meet challenges and demonstrating resiliency via adaptability, developing communities and valuing their contribution to ending the COVID-19 pandemic. Self-identified AFPC competencies contributing to their ability to manage their worklife included care-provider, professional, leader-manager, collaborator and scholar. Conclusion: Pharmacists accepted their additional responsibility of managing COVID-19 vaccines during the COVID-19 pandemic. However, they expressed some challenges with this role. To ensure sustainability of these services, prioritizing adequate resources, work processes and efficient communication with all relevant stakeholder groups, including public health, government and corporate leaders, is recommended for the future. Can Pharm J (Ott) 2023;156(Suppl):xx-xx.

CARD (Comfort Ask Relax Distract) for community pharmacy vaccinations in children: Effect on immunization stress-related responses and satisfaction.

Introduction: CARD (Comfort Ask Relax Distract) is a vaccine delivery program demonstrated to reduce pain, fear and associated immunization stress-related responses (ISRR) in children undergoing vaccinations at school. This study evaluated CARD's clinical impact when integrated into community pharmacy-based pediatric vaccinations. Methods: This was a before-and-after CARD implementation study in 5 independent pharmacies offering COVID-19 vaccinations to children aged 5-11 years. No changes were made to practices in the "before" phase. CARD interventions were integrated in the "after" phase (e.g., children prepared a coping plan using a checklist, distraction toolkits were placed in waiting and vaccination spaces, vaccinations were performed with privacy, needles were obscured). Children self-reported ISRR, including fear, pain and dizziness during vaccination, and both children and parents/caregivers (herein, parents) compared the child's experience to their last needle (better, same, worse). In the "after" phase, parents and children reported how much CARD helped (not at all, a little bit, a moderate amount, a lot). Results: The study was conducted between January 16 and March 20, 2022. Altogether, 152 children participated (71 before and 81 after CARD); demographic characteristics did not differ. Children's self-reported fear was lower after CARD, when assessed continuously (2.5 vs 3.7 out of 10; p = 0.02) or dichotomously, using a cut-off of 0 vs >0 (58% vs 80%; p = 0.01). Pain was lower when assessed dichotomously (<2 vs ≥2; p = 0.03). There was no difference in dizziness. After CARD, children and parents reported more positive experiences compared to the child's last needle (p = 0.01, both analyses) and more children and parents reported that distraction and child participation in the process were helpful (p < 0.001, both analyses). Overall, 92% of children and 91% of parents said CARD helped. Conclusion: CARD reduced children's fear and improved vaccination experiences for children and parents when integrated in community pharmacy-based vaccinations.

Integration of CARD (Comfort Ask Relax Distract) for COVID-19 community pharmacy vaccination in children: Effect on implementation outcomes.

Introduction: Community pharmacists report that providing vaccinations can be challenging, particularly if the vaccine recipient is a child, because of heightened levels of fear. The objective of this study was to determine acceptability and feasibility of the CARD (Comfort Ask Relax Distract) system as a vaccination delivery framework for children receiving COVID-19 vaccinations in a community pharmacy setting. CARD incorporates evidence-based interventions that reduce fear and immunization stress-related responses in vaccine recipients and was demonstrated to be effective and feasible in other vaccination settings providing vaccinations to children and adults. Methods: This mixed-methods study involved 5 independent pharmacies (with 6 vaccinators) offering COVID-19 vaccinations to children between 5 and 11 years of age. Vaccinating staff and implementation leads from the pharmacy organization participated in a small-scale CARD implementation project (before-and-after design). Afterwards, they filled in quantitative surveys and provided qualitative feedback about their perceptions and experiences in focus group discussions. Qualitative data were analyzed deductively, using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted between January 16 and March 20, 2022. Across both quantitative and qualitative measures, vaccinating staff reported positive attitudes about CARD and alignment with their professional roles. They reported that CARD reduced children's fear and improved the vaccination experiences in children and parents and for themselves. Vaccinators reported increased confidence due to CARD. They reported compatibility of CARD interventions within their practice and that it was time neutral. They maintained use of some interventions after the study. They also provided suggestions and shared concerns about fidelity and future feasibility of continuing various components of the program. Conclusion: CARD was demonstrated to be acceptable and feasible by vaccinators performing vaccinations in children in community pharmacies.

Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial.

BACKGROUND: Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada. METHODS: In a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student's choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™. RESULTS: Nine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation. CONCLUSION: While most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov ( NCT03948633 ); Submitted April 24, 2019.

Overview of a Knowledge Translation (KT) Project to improve the vaccination experience at school: The CARD™ System.

BACKGROUND: Students experience fear, pain, and fainting during vaccinations at school. While evidence-based interventions exist, no Knowledge Translation (KT) interventions have been developed to mitigate these symptoms. A multidisciplinary team-the Pain Pain Go Away Team-was assembled to address this knowledge-to-care gap. This manuscript provides an overview of the methodology, knowledge products, and impact of an evidence-based KT program developed and implemented to improve the vaccination experience at school. METHODS: We adapted knowledge and assessed the barriers to knowledge use via focus group interviews with key stakeholder groups involved in school-based vaccinations: students, nurses, school staff, and parents. Next, we developed project-specific goals and data collection tools and collected baseline data. We then created a multifaceted KT intervention called The CARD™ System (C-Comfort, A-Ask, R-Relax, D-Distract) to provide a framework for planning and delivering vaccinations using a student-centred approach. Selected KT tools from this framework were reviewed in additional focus groups held in all stakeholder groups. The multifaceted KT intervention was then finalized and implemented in stages in two projects including grade 7 students undergoing school vaccinations and impact on student outcomes (e.g., symptoms of fear, pain, dizziness) and process outcomes (e.g., utilization of interventions that reduce student symptoms, vaccination rate) were assessed. RESULTS: Participants reported that improving the vaccination experience is important. Based on participant feedback, an evidence-based multifaceted KT intervention called The CARD™ System was developed that addresses user needs and preferences. Selected KT tools of this intervention were demonstrated to be acceptable and to improve knowledge and attitudes about vaccination in the stakeholder groups. In two separate implementation projects, CARD™ helped grade 7 students prepare for vaccinations and positively impacted on their vaccination experiences. CARD™ improved vaccination experiences for other stakeholder groups as well. There was no evidence of an impact on school vaccination rates. CONCLUSION: We developed and implemented a promising multifaceted KT intervention called The CARD™ System to address vaccination-associated pain, fear, and fainting. Future research is recommended to determine impact in students of different ages and in different geographical regions and clinical contexts.

Piloting The CARD™ System for education of students about vaccination: Does it improve the vaccination experience at school?

OBJECTIVE: Many students are fearful of vaccine injection-associated pain. In prior research, we created Knowledge Translation (KT) tools to address school vaccinations and associated pain, fear, and fainting. The objectives of this pilot implementation project were to determine the acceptability and impact of these KT tools on student knowledge, attitudes, and perceptions of their vaccination experience. METHODS: Pre-post mixed methods design. Students in an independent school in the Greater Toronto Area, Ontario, participated in two separate focus groups before and after school vaccinations. In both sessions, they independently completed a knowledge and attitudes survey, reviewed three KT tools (two videos and one pamphlet) and then repeated the knowledge and attitudes survey. They provided structured and qualitative feedback about the KT tools and described the impact of the education on the vaccination experience. RESULTS: Altogether, 11 grade 7 students participated. Knowledge scores were higher post-tool review compared to baseline in the first focus group. There was no significant difference in fear scores and attitudes about getting vaccinated. Qualitative feedback was categorized into two themes: intervention characteristics and characteristics of the school environment. Students reported the KT tools helped them to prepare for vaccination. They used the information on vaccination day to reduce their own fear and pain and to assist peers. They believed all students should view the KT tools. Students reported that teachers and nurses did not do enough to make vaccinations a positive experience. For example, they did not provide a private setting as an option for vaccination and prevented them from using some coping strategies recommended in the KT tools. DISCUSSION: This study provides preliminary evidence of the acceptability and positive impact of the KT tools on students' vaccination experiences. Future research is recommended that involves inclusion of all students and adults in the KT intervention.

Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial.

BACKGROUND: Parents have reported that they want to learn how to reduce pain in infants during vaccinations. Our objective was to compare different levels of intensity of postnatal education about pain mitigation on parental self-reported use of interventions at future infant vaccinations. METHODS: We conducted a longitudinal, 3-group parallel, add-on, randomized controlled trial on the postnatal ward of a hospital. New mothers, unaware of the hypothesis, were randomly assigned to 1 of 3 intervention groups and 3 follow-up groups (i.e., 9 groups, 3 × 3). The 3 intervention groups were control (general immunization information), pain pamphlet (pain mitigation information), and pain pamphlet and pain video (pain mitigation information). Both pain mitigation education groups also received general immunization information. The 3 follow-up groups were 2-, 4- and 6-month infant vaccinations. Mothers reported use of breastfeeding, sucrose and topical anesthetics during infant vaccinations in a telephone survey. RESULTS: Of 3420 participants, follow-up was available for 2549 (75%): 36.1%, 34.2% and 29.7% reported on pain mitigation practices at 2-, 4- and 6-month vaccinations, respectively (p = 0.9). Maternal characteristics did not differ (p > 0.05): mean age, 33.6 years; 58% were primipara. Utilization of any intervention (breastfeeding, sucrose or topical anesthetics) was 53.2%, 61.4% and 63.0% for control, pain pamphlet, and pain pamphlet and pain video groups, respectively (p < 0.001); both pain education groups had higher utilization than the control group, but did not differ from one another. Uptake differed among intervention groups at 2 and 4 months but not at 6 months. INTERPRETATION: Hospital-based postnatal education increased parental use of pain interventions at infant vaccinations and can be added to existing education. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01937143.

Taking the sting out of school-based immunizations.

Pain and fear widely contribute to negative experiences for students during school-based immunizations. In this preliminary research, we used a pre-existing network of 50 schools across Canada that participated in a biannual national immunization poster competition for grade 6 students organized by Immunize Canada to survey principals, teachers and students about their experiences with immunization pain and fear, how they want to learn about managing pain and fear and opportunities to include this information in the process of immunization. Responses revealed that both pain and fear are relevant to the immunization experience and that education and interventions are welcome by students and school staff. This may lead to improved attitudes about immunization, as well as future compliance with recommended immunizations.

La douleur et la peur contribuent largement aux expériences négatives des élèves lors de la vaccination scolaire. Dans le cadre de la présente recherche préliminaire, les auteurs ont recouru à un réseau déjà formé de 50 écoles du Canada qui avaient participé à un concours national bisannuel d'affiches sur la vaccination organisé par Immunisation Canada auprès d'élèves de sixième année. Ils ont sondé les directions d'école, les enseignants et les élèves au sujet de leurs expériences de douleur et de peur liées à la vaccination, de ce qu'ils veulent savoir sur la gestion de la douleur et de la peur ainsi que des possibilités d'intégrer l'information au processus de vaccination. Les réponses ont révélé que la douleur et la peur s'associent à l'expérience de vaccination et que les élèves et le personnel scolaire seraient heureux de recevoir de l'information et des interventions. Ces mesures pourraient améliorer les attitudes vis-à-vis de la vaccination et favoriser l'adhérence aux futurs vaccins.

Exposure-based Interventions for the management of individuals with high levels of needle fear across the lifespan: a clinical practice guideline and call for further research.

Needle fear typically begins in childhood and represents an important health-related issue across the lifespan. Individuals who are highly fearful of needles frequently avoid health care. Although guidance exists for managing needle pain and fear during procedures, the most highly fearful may refuse or abstain from such procedures. The purpose of a clinical practice guideline (CPG) is to provide actionable instruction on the management of a particular health concern; this guidance emerges from a systematic process. Using evidence from a rigorous systematic review interpreted by an expert panel, this CPG provides recommendations on exposure-based interventions for high levels of needle fear in children and adults. The AGREE-II, GRADE, and Cochrane methodologies were used. Exposure-based interventions were included. The included evidence was very low quality on average. Strong recommendations include the following. In vivo (live/in person) exposure-based therapy is recommended (vs. no treatment) for children seven years and older and adults with high levels of needle fear. Non-in vivo (imaginal, computer-based) exposure (vs. no treatment) is recommended for individuals (over seven years of age) who are unwilling to undergo in vivo exposure. Although there were no included trials which examined children < 7 years, exposure-based interventions are discussed as good clinical practice. Implementation considerations are discussed and clinical tools are provided. Utilization of these recommended practices may lead to improved health outcomes due to better health care compliance. Research on the understanding and treatment of high levels of needle fear is urgently needed; specific recommendations are provided.

CARD (Comfort Ask Relax Distract) for school-based immunizations in Calgary, Canada: a pragmatic cluster trial.

ABSTRACT: School-based immunizations are fear-inducing events for many students and contribute to vaccine hesitancy. We developed an immunization delivery framework called the CARD (Comfort Ask Relax Distract) system that incorporates evidence-based interventions to improve the experience (eg, reduce fear, pain, dizziness). We evaluated CARD in grades 6 and 9 students in Calgary, Canada. In this pragmatic, hybrid, effectiveness-implementation, cluster trial, we randomized 8 Community Health Centres providing regional immunization services to CARD or control (usual care). In the CARD group, public health staff educated students about CARD and planned processes to reduce fear cues and support student coping choices during immunization. Students self-reported fear, pain, and dizziness during immunization using a 0-10 numerical rating scale; staff recorded procedure details, including vaccines administered, fainting episodes, and coping strategies used. Staff participated in focus groups afterward. Altogether, 8839 children from 105 schools in the 2019 to 2020 school calendar year were included. Fear was lower for CARD (mean = 3.6 [SD = 3.1] vs control 4.1 [3.2]; mean difference = -0.5; 95% confidence interval = -0.74 to -0.21; P < 0.001). Effectiveness persisted after stratification by student gender (male and female) and grade level (grade 6 and grade 9). Other symptoms did not differ. Compared with control, CARD students used peers, privacy, muscle tension, and topical anesthetics more; verbal distraction, deep breathing, and adult support were used less frequently ( P < 0.05, all analyses). Immunization rate did not differ. Staff reported positive to neutral attitudes about CARD. In summary, this pragmatic trial demonstrated that CARD improved the immunization experiences of students at school.

A social media intervention for communicating vaccine safety in low- and middle-income countries: protocol for a pilot study.

Vaccine safety is a concern that continues to drive hesitancy and refusal in populations in low-and-middle income countries (LMICs). Communicating about vaccine safety is a strategy that can successfully change personal and community perceptions and behaviors toward vaccination. The COVID-19 infodemic emergency with the rapid rollout of new vaccines and new technology, demonstrated the need for good and effective vaccine safety communication. The Vaccine Safety Net (VSN), a WHO-led global network of websites that provide reliable information on vaccine safety offers the ideal environment for gathering web and social media analytics for measuring impact of vaccine safety messages. Its members work with a wide range of populations, in different geographic locations and at many levels including national, regional, and local. We propose to undertake a pilot study to evaluate the feasibility of implementing COVID-19 vaccine safety communications with VSN members working in LMICs and to assess the impact of communications on public knowledge, attitudes, and perceptions.

LetsTalkShots: personalized vaccine risk communication.

Introduction: Vaccine hesitancy is a global health threat undermining control of many vaccine-preventable diseases. Patient-level education has largely been ineffective in reducing vaccine concerns and increasing vaccine uptake. We built and evaluated a personalized vaccine risk communication website called LetsTalkShots in English, Spanish and French (Canadian) for vaccines across the lifespan. LetsTalkShots tailors lived experiences, credible sources and informational animations to disseminate the right message from the right messenger to the right person, applying a broad range of behavioral theories. Methods: We used mixed-methods research to test our animation and some aspects of credible sources and personal narratives. We conducted 67 discussion groups (n = 325 persons), stratified by race/ethnicity (African American, Hispanic, and White people) and population (e.g., parents, pregnant women, adolescents, younger adults, and older adults). Using a large Ipsos survey among English-speaking respondents (n = 2,272), we tested animations aligned with vaccine concerns and specific to population (e.g., parents of children, parents of adolescents, younger adults, older adults). Results: Discussion groups provided robust feedback specific to each animation as well as areas for improvements across animations. Most respondents indicated that the information presented was interesting (85.5%), clear (96.0%), helpful (87.0%), and trustworthy (82.2%). Discussion: Tailored vaccine risk communication can assist decision makers as they consider vaccination for themselves, their families, and their communities. LetsTalkShots presents a model for personalized communication in other areas of medicine and public health.

Corrigendum: LetsTalkShots: personalized vaccine risk communication.

[This corrects the article DOI: 10.3389/fpubh.2023.1195751.].

Measuring the Burden of Infodemics: Summary of the Methods and Results of the Fifth WHO Infodemic Management Conference.

Background: An infodemic is excess information, including false or misleading information, that spreads in digital and physical environments during a public health emergency. The COVID-19 pandemic has been accompanied by an unprecedented global infodemic that has led to confusion about the benefits of medical and public health interventions, with substantial impact on risk-taking and health-seeking behaviors, eroding trust in health authorities and compromising the effectiveness of public health responses and policies. Standardized measures are needed to quantify the harmful impacts of the infodemic in a systematic and methodologically robust manner, as well as harmonizing highly divergent approaches currently explored for this purpose. This can serve as a foundation for a systematic, evidence-based approach to monitoring, identifying, and mitigating future infodemic harms in emergency preparedness and prevention. Objective: In this paper, we summarize the Fifth World Health Organization (WHO) Infodemic Management Conference structure, proceedings, outcomes, and proposed actions seeking to identify the interdisciplinary approaches and frameworks needed to enable the measurement of the burden of infodemics. Methods: An iterative human-centered design (HCD) approach and concept mapping were used to facilitate focused discussions and allow for the generation of actionable outcomes and recommendations. The discussions included 86 participants representing diverse scientific disciplines and health authorities from 28 countries across all WHO regions, along with observers from civil society and global public health-implementing partners. A thematic map capturing the concepts matching the key contributing factors to the public health burden of infodemics was used throughout the conference to frame and contextualize discussions. Five key areas for immediate action were identified. Results: The 5 key areas for the development of metrics to assess the burden of infodemics and associated interventions included (1) developing standardized definitions and ensuring the adoption thereof; (2) improving the map of concepts influencing the burden of infodemics; (3) conducting a review of evidence, tools, and data sources; (4) setting up a technical working group; and (5) addressing immediate priorities for postpandemic recovery and resilience building. The summary report consolidated group input toward a common vocabulary with standardized terms, concepts, study designs, measures, and tools to estimate the burden of infodemics and the effectiveness of infodemic management interventions. Conclusions: Standardizing measurement is the basis for documenting the burden of infodemics on health systems and population health during emergencies. Investment is needed into the development of practical, affordable, evidence-based, and systematic methods that are legally and ethically balanced for monitoring infodemics; generating diagnostics, infodemic insights, and recommendations; and developing interventions, action-oriented guidance, policies, support options, mechanisms, and tools for infodemic managers and emergency program managers.

Digital tools, multidisciplinarity and innovation for communicating vaccine safety in the COVID-19 era.

The research on the anti-SARS-CoV-2 vaccines and their commercialization is an opportunity to test and consolidate the current knowledge along with the diverse available tools related to vaccine communication.In this paper we explore the value of a multidisciplinary approach in this field: vaccine communication activities can be combined with insights from data science, risk communication, behavior change, design thinking and digital marketing. Methodologies derived from innovation and human-centered design can contribute to the development and testing of vaccine promotion campaigns, speeding up processes and streamlining the production of evidence in this area. The multiple activities involving the anti-SARS-CoV-2 vaccine could be the fertile ground in which to develop, test and refine effective frameworks to transfer data acquired through listening strategies into effective vaccine promotion campaigns. The World Health Organization's Vaccine Safety Net is an interesting example of trusted information sources that aim toward using digital tools and innovative methodologies for communicating science-based information on vaccine safety at the global level.

Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial.

BACKGROUND: The CARD (Comfort Ask Relax Distract) system is a vaccine delivery framework that integrates evidence-based interventions to reduce stress-related responses and improve the vaccination experience for children undergoing vaccinations at school. In preliminary studies, CARD was acceptable and effective. The objective was to evaluate CARD in a large, pragmatic trial to confirm its effectiveness in real-world settings. METHODS: Hybrid effectiveness-implementation cluster randomized trial in schools receiving vaccination services from Wellington-Dufferin-Guelph Public Health. Forty schools with grade 7 students (12 years old) were randomized to CARD and control (n = 20/group). Nurses in CARD schools planned clinics with principals and educated students about CARD ahead of time. Principals disseminated information to staff and parents and sent reminders. Vaccination day processes minimized fear and facilitated student self-selected coping strategies. Nurses in control schools followed usual practices, which excluded principal meetings, education, reminders, and systematic integration of fear-reducing or child-selected coping strategies. Outcomes included stress-related symptoms (fear - primary outcome, pain, dizziness, fainting, post-vaccination reactions), use of coping interventions, vaccination uptake, attitudes and implementation outcomes (acceptability, appropriateness, feasibility, fidelity). RESULTS: Altogether, 1919 students were included. Fear and pain were lower in CARD schools: OR 0.65 (95% CI 0.47-0.90) and OR 0.62 (95% CI 0.50-0.77), respectively. No students fainted in CARD schools compared to 0.8% in control (p = 0.02). Dizziness and post-vaccination reactions did not differ. Student-led coping interventions were used more frequently in CARD schools. Vaccination uptake was 76.1% in CARD schools and 72.5% in control schools (OR 1.13 (95% CI 0.85-1.50)). Staff and students had positive attitudes about CARD and implementation outcomes; however, recommendations were made to improve fidelity. DISCUSSION: CARD reduced stress-related responses in students undergoing vaccinations at school and was positively received by students and public health staff. CARD is recommended to improve the quality of vaccination delivery services. TRIAL REGISTRATION: NCT03966300.

Letting kids play their CARDs (Comfort, Ask, Relax, Distract) to help cope with needle-related fear and pain: Results from user testing.

This study examined perceptions of children and parents about a new web-based CARD (Comfort, Ask, Relax, Distract) game that teaches children how to cope with needle-related pain and fear. A convenience sample of 15 child-parent dyads (children, 6-12 years) participated. Children played the game on a handheld device while being virtually monitored. Activity tracking revealed most children engaged with multiple components. Children reported they understood the game, it was easy to play, they learned coping strategies and believed they could implement them. Children reported lower fear of needles after playing. Parents liked the simplicity and variety of game activities. Most children and parents reported they would use the game or its coping strategies for future needles and would recommend the game. In summary, children and parents found the CARD web game acceptable and appropriate. Future studies can evaluate its effectiveness when integrated into upcoming needle procedures like COVID-19 vaccinations.