Abstract
The aim of this study was to evaluate parents’ perception of their child(ren)’s distress before, during, and after influenza (flu) vaccination, and their perceived effectiveness of pain and distress management strategies used during the vaccination process. This is a cross-sectional survey of parents attending Children’s Hospital of Eastern Ontario’s 2018 family flu clinic. After vaccination, parents completed a paper-based survey concerning demographics, fear and distress levels, and use and perceived effectiveness of pain/distress management interventions provided before and during the vaccination process. All survey data were entered into Research Electronic Data Capture (REDCap). Quantitative data were analyzed using descriptive statistics; qualitative data were analyzed using content analysis. A total of 164 parents completed the survey, reporting data on 327 children aged 6 months to 18 years (83% of children were vaccinated). Of 327 children, nearly half (n = 142, 44%) were reported to be moderately to severely distressed before, during, or after the vaccination process. The parents reported that 268 (82%) children received pain/distress management strategies during vaccination. Over half (n = 138, 57%) of the parents reported that the strategies used were very effective. Despite frequent use and parents’ perceived effectiveness of pain/distress management interventions, nearly half of the children were perceived by parents as moderately to severely distressed during the vaccination process.
Introduction
Immunization is among the most effective and successful healthcare strategy that has reduced illnesses, disabilities, and death caused by infectious or vaccine-preventable diseases (WHO, 2013). Herd immunity protects against epidemics as long as a significant proportion of individuals in a population are immunized against the disease. Accordingly, routine vaccination for children is highly encouraged as children play a vital role in transmitting infections (Kempe et al., 2005) and are highly susceptible to infections (Tartof et al., 2016). However, sufficient immunization coverage remains a challenge worldwide (WHO, 2013). This could be due to discrepancies between countries in their efforts to mitigate this issue. For instance, in Australia, legal intervention such as the “No Jab No Pay” legislation incentivizes the completion of children’s vaccine schedule, as per the National Immunization Program, with access to financial welfare for families (Cheng et al., 2018). On the other hand, Canada has developed a National Immunization Strategy where vaccination coverage goals are elaborated per those of the WHO for infants, childhood, adolescent, and adult vaccines that are publicly funded (Vaccination Coverage Goals and Vaccine Preventable Disease Reduction Targets by 2025 - Canada.ca, n.d.).
One factor which may contribute to parents’ reluctance to have their children vaccinated is fear of pain (Taddio et al., 2012). Fear of needles is prevalent in both healthy children who undergo routine vaccinations and children with chronic illnesses who require frequent needle-related procedures (McMurtry, 2013).
Various pain management strategies have been shown to effectively reduce needle-related pain in infants and children. For instance, a clinical practice guideline published by HELPinKids&Adults team recommends pharmacological and nonpharmacological interventions, in age-based algorithms, to reduce pain during vaccinations (Taddio et al., 2015). As nonpharmacological interventions, they recommend breastfeeding for infants up to 2 years, positioning children upright, and holding neonates skin-to-skin during injections (Taddio et al., 2015). Recommended pharmacological interventions include giving infants small volumes of sucrose prior to injection (Taddio et al., 2015). For children up to 12 years, especially those with a known fear of needles, applying topical anesthetics to the site of injection 40–60 min before injections (Abuelkheir et al., 2014) is recommended. These interventions are effective in alleviating anxiety related to pain, all while serving as a preventative strategy to deter needle-related fear and distress, which in turn, may deter healthcare avoidance behavior (Reading, 2009; Taddio et al., 2010). However, despite these recommendations and supporting evidence, studies demonstrate inconsistent translation of these interventions into clinical practice (Franck et al., 2000; Harrison et al., 2014, 2015; Russell and Harrison, 2015; Taddio et al., 2009).
In Canada, annual vaccinations against influenza serve as a primary healthcare prevention practice (Parkins et al., 2009). Children’s Hospital of Eastern Ontario (CHEO) holds an annual Family Flu Clinic (FFC) for its employees and their families. Since 2012’s clinic, the CHEO Nursing Research lead, in partnership with CHEO Occupational Health, Child Life team, and FFC vaccinators, has put into practice multiple evidence-based pain and distress management interventions, such as those recommended in HELPinKids&Adults’ clinical practice guideline (Taddio et al., 2015), which aims to reduce pain and distress in infants and children attending the clinic (Ouach et al., 2018). However, a study at CHEO’s 2017 FFC concluded that despite the use of evidence-based pain and distress management strategies, more than half of the children were perceived to be distressed by observers, as well as by their parents (Ouach et al., 2018). It is unknown if this emotional distress, despite using recommended pain and distress management strategies, is due to preexisting fear of needles or a lack of use or effectiveness of recommended strategies in some children, as used in this FFC context.
For ethical reasons, reducing children’s pain and distress is essential when running immunization clinics. Accordingly, since 2015, previous quality assurance studies have been conducted in the CHEO’s FFC setting to evaluate effectiveness of offered pain and distress management strategies, which helped plan appropriate resources and interventions for future FFC (Ouach et al., 2018). Hence, ongoing evaluation and building on previous work are required for continually assessing and improving processes and outcomes.
Aim
This continuous quality improvement study aims to evaluate parents’ perception of their child(ren)’s distress before, during, and after influenza vaccination at the CHEO FFC; and evaluate parents’ perceived effectiveness of pain and distress management strategies during influenza vaccination at the FFC.
Materials and methods
Study design
A cross-sectional survey (see Supplementary Material 4) was completed by parents of children attending CHEO’s 2018 FFC. Throughout the survey, “distress” was defined as a combination of pain, anxiety, or fear experienced by children before and during painful medical procedures, consistent with a recent clinical practice guideline (Taddio et al., 2015). Emotional distress was assessed in this study to better understand which age-group was most susceptible to feeling distressed before or during vaccination, to improve the planning of future CHEO FFC in terms of the availability of appropriate resources and interventions tailored specifically to the said age-group.
Setting
Annually, an FFC is hosted at CHEO, a level III Canadian pediatric hospital, located in Ottawa, Ontario, Canada. The FFC takes place over 4 h during the evening time in early November. All CHEO staff are invited to attend with their families, and between 400 and 700 individuals who are part of CHEO’s staff and their families attend each year. Every year, information about effective ways to reduce vaccination pain and distress (Supplementary Material 1) is posted on the CHEO’s Intranet site for staff and families to access. Vaccinations are carried out mainly in the hospital’s cafeteria, by 14 CHEO employees, including registered nurses, practical nurses, and pharmacists. In addition, two vaccinators carried out vaccinations in quiet rooms, separate from the cafeteria. Prior to the FFC, staff are given information about the standard approach for injection technique (rapid, with no aspiration) (Taddio et al., 2013) and pain reduction strategies, including breastfeeding or sucrose for infants, distraction, and vapocoolant for children older than 3 years, with consent. In addition, various other means of support are available such as child life specialists (CLSs), therapy dogs, and cognitive support by the CLSs and vaccination staff. CLSs used various age-appropriate distraction mechanisms to help reduce children’s fear and distress.
The CHEO cafeteria was set up to host the FFC while providing a fun and child-friendly environment. For example, children’s music and dance videos were projected on a large screen, a coloring station was set up, and ice cream was available for children following their vaccinations. In addition, a hospital’s clown was present to provide entertainment. Alternatively, two private, quiet rooms were offered as an option for children who were perceived by parents as more distressed or anxious about vaccination—this option provided one-on-one support from a CLS and therapy dogs in a quieter environment. Those rooms were located close to the main cafeteria; therefore, there were no problems with feasibility of running the clinic. Following vaccination, families were asked to remain on-site for at least 15 min to monitor for adverse reactions, during which ice cream and activities were available. During this time, parents were invited to complete the survey.
Ethical approval
The study was approved by the CHEO Research Ethics Board (#17/152X).
Data collection processes
Eligibility criteria
This study included parents of infant(s) and child(ren) between ages 6 months and 18 years who had received their influenza vaccine at CHEO’s 2018 FFC, and who consented to take part in the study.
Data collection
Six trained research assistants approached all parents located in the waiting area, during their 15-min postvaccination period, to invite them to participate in the study. Parents completed surveys in the waiting area, which was located on the other side of vaccination stations in the cafeteria, where an ice-cream station and video screen were. Parents handed their survey back to an identifiable research assistant once completed. The paper-based survey contained 11 questions related to the following: parents’ fear of needles, location of vaccination (i.e., cafeteria or private room), children’s demographics (number of children in the family, age, and sex), perceived overall fear level of needles of the children, perceived distress level of children before, during, and after vaccination (See question 7 in Supplementary Material 4 for time periods.), pain treatment used during the vaccination process and its perceived effectiveness, and willingness to be contacted for future research.
Fear and distress were reported on a six-point Likert scale, with zero meaning “not at all fearful of needles” or “not at all distressed” and five meaning “extremely fearful of needles” or “extremely distressed.” Effectiveness of used pain treatments was reported as “very effective,” “somewhat effective,” or “not effective.” Parents reported pain and distress management strategies used during their child(ren)’s vaccination by ticking them off from a provided checklist of all available interventions during the CHEO FFC. A comment box was included for parents to make further comments.
Data storage
Following survey completion, contact information pages were detached from each parent survey. After the clinic, both the contact information and parent surveys were stored in a locked cabinet drawer in the senior investigator’s (Harrison) locked office at the CHEO Research Institute.
Data entry
All survey data were manually entered by a trained research assistant into an electronic data entry form in Research Electronic Data Capture (REDCap) (Harris et al., 2009). Data entered into REDCap were then double-checked by a second research team member to ascertain accuracy.
Data analysis
Data imported into REDCap were exported to a password-protected Excel file. Each child from the surveyed population was allocated a unique identifying number.
Quantitative data were analyzed using descriptive statistics. Qualitative data from parents’ comments were analyzed using content analysis guided by procedures described by Sandelowski (2000).
Results
Parent survey
Characteristics of children (N = 327) and families (N = 164).
NB. Not all questions were answered by all families. CHEO: Children’s Hospital of Eastern Ontario.
Perceived prevalence of fear
Over one-third (n = 122, 38%) of the children were reported to have a moderate to severe fear of needles (Figure 1). Eight parents (7%) of these 122 children also reported their own fear of needles. Severity of needle fears in children (N = 327) by age-group. *Fear was measured on a 6-point Likert scale, with 0 meaning “not at all fearful of needles” and 5 meaning “extremely fearful of needles.” Value over all of the vertical bars represents the number (n) of children.
Perceived prevalence of distress
As shown in Figure 2, over one-third of children were perceived by their parents to be distressed about the upcoming vaccination 24 h prior, with 32% of these being the toddler age-group (13 months–3 years). Nearly half (n = 174, 44%) of the children were reported to be moderately to severely distressed before, during, or after vaccination (Figure 2). About 35% (n = 116) of children were reported to be moderately to severely distressed immediately before the injection, and 34% (n = 111) were moderately to severely distressed during vaccination. Following completion of the injection, 10% (n = 34) of children were reported to be moderately to severely distressed. Toddlers (13 months–3 years) and children between the ages of 4 and 12 years were most frequently reported to be moderately to severely distressed before and during vaccination. Only one-third of all children (n = 109, 34%) were perceived by their parents as not distressed at any point during the vaccination process. Proportion of children experiencing moderate to severe* distress during the vaccination procedure, as perceived by parents.aImmediately before = from the time the family lined up at the clinic to the time the child sat in the vaccination chair. bDuring = from the time the child sat in the vaccination chair to the time the bandage was applied. cAfter = from the time the bandage was applied to the time the child left the vaccination chair. **Value over all of the vertical bars represents the number (n) of children.
Perceived effectiveness of pain management interventions
Use of pain management strategies a before and/or during the vaccination, categorized by physical, psychological, pharmacological, and perceived effectiveness by parents.
Astra Pharmaceuticals, L.P. Wayne, PA 19087.
aSee Supplementary Material 2 for a graph representation of the categorized strategies that are stratified according to their level of evidence-based effectiveness.
bStrategies used only in the infant population.
cEutectic Mixture of Local Anesthetics. Astra Pharmaceuticals, L.P. Wayne, PA 19087.
dDenominator (N), N = 268, represents the subset of respondents who selected at least one strategy used for their child before and/or during the vaccination.
Qualitative assessment of the comments left by parents in the “other comments” box in the survey
A total of 86 parents (52%) wrote comments at the end of the survey. Comments were organized into four themes, and the most common theme (positive experiences) was further classified into five subthemes. A summary of themes and subthemes is presented in a table (Supplementary Material 3), including example quotes. Nearly three-quarters (n = 67, 78%) of comments were of a positive nature, including expressing appreciation (n = 25, 37%) and positive feedback on pain/distress management strategies used (n = 24, 36%), staff (n = 10, 15%), clinic’s atmosphere (n = 8, 12%), and organization of the flu clinic (n = 4, 6%). The remaining themes’ comments (n = 19, 22%) varied in valence as some were positive (n = 5, 26%) and others were constructive (n = 14, 74%). Eight parents commented on their children’s fear and distress levels, eight parents said that their children’s distress might be influenced by that of other children who were being vaccinated, and six parents gave recommendations for future clinics (Supplementary Material 3).
Discussion
Data on 327 children from this cross-sectional survey of 164 parents attending an FFC showed that nearly half of the children were perceived by parents as moderately to severely distressed during the vaccination process—despite frequent use and parents’ perceived effectiveness of evidence-based pain/distress management interventions. In addition, over one-third of children had a preexisting moderate to severe fear of needles, and 32% of the younger children were distressed 24 h prior to the vaccination.
Fear and distress levels of children throughout the vaccination procedure
Needle fear is a known barrier to compliance with immunization. In a study pertaining specifically to the influenza vaccine among healthcare workers, fear of injections accounted for 4–26% of noncompliers with vaccinations (Taddio et al., 2012). Painful experiences related to past negative needle procedures can be a source of avoidance behaviors for later similar and vital procedures.
In the current study, about one-third of children were perceived to be moderately to severely distressed before the vaccination process. The same proportion of children were highly distressed during vaccination, highlighting a high frequency of needle-related distress and fear in children. This level of fear and distress was most commonly reported in toddlers and children between ages of 4 and 12 years. These results are comparable to those of an observational study in which 90% of 15- to 18-month-old children and 45% of children between ages of 4 and 6 years demonstrated signs of severe distress during vaccination procedures (Jacobson et al., 2001).
In another study evaluating distress related to needles during venipuncture, toddlers aged two and a half to 6 years and preadolescents aged 7–12 years were observed to be highly distressed (Humphrey et al., 1992). Considering that pain and fear are contributing factors for noncompliance with vaccinations (Russell and Harrison, 2015; Taddio et al., 2012), it is essential to implement and evaluate interventions to reduce such negative experiences and subsequently facilitate higher immunization coverage (Taddio et al., 2009).
Use and perceived effectiveness of pain management during vaccination
Recommendations for evidence-based pain and distress management interventions are available for healthcare providers and administrators of vaccination clinics, although these interventions are not consistently used (Harrison et al., 2015; Russel and Harrison, 2015; Taddio et al., 2009). In this study, most children received at least one pain/distress management intervention during the vaccination process, for which most parents reported that they were somewhat or very effective.
However, despite parents’ satisfaction with the effectiveness of the pain and distress management interventions used, nearly half of children still experienced moderate to severe distress before, during, and/or after vaccination. This type of discrepancy is in agreement with the literature suggesting that parental satisfaction with interventions used may not always be related to the absence of pain as a result of their use (Russel and Harrison, 2015). Accordingly, parental reporting of their children’s pain and fear of needles may be either underreported or overestimated (Taddio et al., 2012).
Pain and distress management strategies can be categorized by the 3P’s, which includes psychological, physical, and pharmacological approaches (Taddio et al., 2010). In this study, psychological interventions were most frequently reported as pain/distress management strategies used during the vaccination procedure, with nearly half of parents reporting using reassuring words. However, evidence of parent–child interactions relevant to painful procedures suggests that children exhibit more distress when reassuring words are used (McMurtry, 2013); hence, reassurance is an intervention that is not recommended for children (Taddio et al., 2015). The use of topical anesthetics as a pharmacological intervention is recommended for children, especially those with a fear of needles (Taddio et al., 2015). However, these were only used in 10% of vaccinated children. The use of a vapocoolant spray immediately before the injection was, however, widely reported. Vapocoolant sprays result in an immediate effect of skin cooling (Taddio et al., 2010), although insufficient evidence exists on the efficacy of skin cooling to reduce sensations of pain during injections (Taddio et al., 2010, 2015). Additionally, upright positioning of the child during injection was most frequently reported as a used physical intervention, with evidence supporting its effectiveness in reducing distress in children during needle-related procedures (Lacey et al., 2008; Sparks et al., 2007; Taddio et al., 2015).
There is little current evidence supporting the efficacy of reassurance in reducing distress in children; however, parents frequently reported the use of reassuring words as a strategy during their children’s vaccination at the FFC. This indicates that there may be a lack of knowledge regarding best ways to reduce pain and distress during vaccinations. A 2015 HELPinKids&Adults clinical guideline strongly recommends that parents be educated about effective pain management strategies ahead of time or on the day of their children’s vaccination as evidence shows an increase in the use of said interventions during vaccination (Taddio et al., 2015). Knowing this, the research team posted a one-page summary of best ways to reduce children’s needle pain and distress on CHEO Intranet, which is accessible by all CHEO staff (See Supplementary Material 1). This poster includes recommendation about timing of upcoming vaccinations, including to explaining to young children just before the procedure. The fact that 32% of young children were already reported to be distressed 24 h prior to the clinic highlights, however, that these young children were aware of the upcoming vaccination. It is not known, however, how many families actually read the poster. Further research evaluating awareness, usefulness, and actual use of this type of information for parents is therefore warranted.
Regarding the feasibility of using strategies implemented in this FFC, as the clinic is conducted in a tertiary referral pediatric hospital, implementation of best pain and distress management practices has been prioritized. Evidence-based pain management strategies tailored to infants, which include breastfeeding, giving small volumes of sucrose, and skin-to-skin care (Harrison et al., 2017; Taddio et al., 2010, 2015), are extremely feasible to implement. At least one of these strategies were used for five of seven infants included in this study. The use of CLSs, including therapy dogs where appropriate, and a child-friendly environment which includes rewards (ice cream) is, however, unlikely to be feasible to implement outside of a pediatric hospital setting.
Strengths and limitations
This study’s sample reflects data from a high proportion of vaccinated children who attended the FFC and is representative of children from most age-groups. Therefore, these findings are useful to inform the planning of future family-based flu vaccine clinics held in high-volume and public settings. However, a selection bias may be considered as not all parents with children who had been vaccinated were approached. This is due to some parents not having waited for 15 min in the designated area as instructed by staff.
Further limitations of this study exist. First, this study was conducted in the CHEO FFC for CHEO staff and their families, who voluntarily attend the clinic for vaccination, hence a population that may be more educated on the topic of vaccination. Our findings cannot therefore be generalized to a population with lower prior vaccine knowledge.
Second, data reported on children’s distress levels throughout the vaccination process, and the use and effectiveness of pain and distress management strategies relied solely on parents’ perceptions and required parents to recall their children’s pain throughout vaccination. However, parents completed the survey within 15 min after their children’s vaccination; therefore, any risk for recall bias was minimized.
Additionally, a lack of validity comes from relying on parents to report all of the pain and distress management interventions used during their child(ren)’s vaccination. Parents were limited as far as reporting the interventions used and that were listed in a checklist of strategies that could have been applied either by themselves or by vaccinators. This could have resulted in parents neglecting to record actions that they may have used.
Moreover, parents reported on their children’s fear and distress based on a six-point Likert scale ranging from zero to five, where only anchors of zero and five were briefly described. This allowed for subjective scoring as parents had to estimate values between zero and five. Also, parents were not given the ability to opt out of a question when it did not apply to them, such as when rating their infants’ perceived level of fear, especially in the younger infants. In future studies, we recommend that survey questions will include the option of “unsure” when rating their children’s fear and distress.
Last, parental satisfaction regarding the effectiveness of interventions used is subjective but is an important factor to consider when evaluating and planning the FFC. As this study was focused on exploring parents’ perceptions of their children’s fear and distress related to vaccinations, staff and children were excluded from the data collection process in this case. However, the FFC setting is extremely busy, and many children were too young to participate in the survey. It is also important to note that the CHEO’s intention throughout the entire duration of the FFC is to distract children, via entertainment, ice cream, music, etc., rather than to focus on their needle experience. Nonetheless, including older children in future research would ensure their voice and perspective are explored.
Implications
Findings from this study will inform the planning of future FFCs. Given that the younger population from this study was perceived as most severely distressed, additional supports for toddlers and children are crucial, as well as further work on translating research into practice to improve use of effective interventions for infants. Consistent use of breastfeeding, skin-to-skin care, or sucrose for all needle-related procedures performed from the newborn period may reduce the risk of development of needle fear at a young age. Parental preparation for vaccination clinics is also crucial for the distress management of their children as parents’ fear of needles may impact that of their children. Also, ensuring that parents receive adequate information about evidence-based pain and distress management interventions before coming to the clinic with their child(ren) is imperative to increase appropriate use of pain- and distress-mitigating strategies for their child(ren).
While this study explored parents’ perceptions, future research on children’s perspectives is warranted. In addition, exploration of vaccinators’ knowledge pertaining to the implementation of pain management strategies, as well as perceived barriers and facilitators for the use of pain management interventions, is needed.
Conclusion
Despite efforts to inform parents and to implement age-appropriate strategies to reduce pain and distress during vaccination in a busy hospital FFC, parents of vaccinated children reported high levels of pain, distress, and needle fears. Consistently using evidence-based strategies during painful procedures for newborns, young infants, and children may help reduce pain, distress, and development of needle fear.
Supplemental Material
sj-pdf-1-chc-10.1177_1367493521994983 – Supplemental Material for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey
Supplemental Material, sj-pdf-1-chc-10.1177_1367493521994983 for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey by Sarah Khadij, Jessica Reszel, Jodi Wilding and Denise Harrison in Journal of Child Health Care
Supplemental Material
sj-pdf-2-chc-10.1177_1367493521994983 – Supplemental Material for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey
Supplemental Material, sj-pdf-2-chc-10.1177_1367493521994983 for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey by Sarah Khadij, Jessica Reszel, Jodi Wilding and Denise Harrison in Journal of Child Health Care
Supplemental Material
sj-pdf-3-chc-10.1177_1367493521994983 – Supplemental Material for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey
Supplemental Material, sj-pdf-3-chc-10.1177_1367493521994983 for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey by Sarah Khadij, Jessica Reszel, Jodi Wilding and Denise Harrison in Journal of Child Health Care
Supplemental Material
sj-pdf-4-chc-10.1177_1367493521994983 – Supplemental Material for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey
Supplemental Material, sj-pdf-4-chc-10.1177_1367493521994983 for Children’s fear and distress during a hospital-based family flu vaccine clinic: A parent survey by Sarah Khadij, Jessica Reszel, Jodi Wilding and Denise Harrison in Journal of Child Health Care
Footnotes
Acknowledgements
We thank all families who participated, the manager of CHEO’s Occupational Health team, the CHEO Child Life team, and the Be Sweet to Babies team of volunteer research assistants for their efforts and support.
We thank the University of Ottawa Undergraduate Research Opportunity Program (UROP) for financially supporting an undergraduate student to help with the study.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Financial support by the University of Ottawa Undergraduate Research Opportunity Program (UROP).
Ethical approval
The study was approved by the CHEO Research Ethics Board (#17/152X).
Supplemental material
Supplemental material for this article is available online.
References
Supplementary Material
Please find the following supplemental material available below.
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