Parent Targeted Interventions in Vaccination Pain Management of Infants
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The overall aim of this study is to investigate the feasibility, acceptability, preliminary
      effectiveness and sustainability of parent-targeted interventions for pain management during
      vaccination of infants. To achieve the goal, a two-phase pilot randomized control trial is
      planned. Study one, currently in the data collection phase, aims i) to evaluate the
      feasibility and acceptability of data collection tools, participants' recruitment procedures
      and implementation process of parent-targeted interventions prior to infant vaccination at
      two, four, or six months. ii) to evaluate the preliminary effectiveness of parent-targeted
      interventions prior to infant vaccination in promoting the use of pain management strategies
      during vaccinations of infants at two, four, or six months. iii) to identify the parent's
      knowledge, use, intention and recommendation to use the recommended pain management
      strategies, and facilitators and barriers influencing the implementation of the
      parent-targeted interventions during vaccinations of infants at two, four, or six months.
      Methods. This study is a prospective multi-faceted two-armed pilot randomized control trial
      (RCT). a pilot randomized control trial. The participants are parents of infants, recruited
      before the infants receive their 2, 4, or 6- month vaccinations, who responded to the online
      invitation and consent to participate in this study. Parents living in Canada and prior to
      the infant receiving one of the three vaccinations were invited to participate through an
      online recruitment process. A sample of 50 parent/infant dyads in each group of control and
      intervention is estimated to be sufficient to achieve the study's goals. The outcome
      measurements are being done by five brief study questionnaires; Brief information of the
      study goals and the researchers' affiliation followed by a hyperlink to the survey were
      posted on different online platforms. Eligible parents of infants who respond to the study
      invitation are being randomly allocated to 1 of 2 groups (Intervention and control). There
      are two interventions in the study one being compared: 1) Be Sweet to Babies Videos and
      Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS&Q. After the intervention, the
      impact of the vaccination pain management video and brochure followed by MIAS&Q questions are
      being evaluated by a brief online survey exploring the use of pain management (breastfeeding
      or sucrose and upright secure holding) during infants' vaccination in both groups. Following
      that, the opinion of parents about the understandability, applicability, feasibility, and
      acceptability of this study are evaluated. All data are being collected electronically using
      REDCap survey tool. SPSS version 23.0 (SPSS Inc, Chicago, Illinois) will be used to perform
      all descriptive and inferential statistical analyses. NVivo version 11.0 (Qualitative data
      analysis Software; QSR International Pty Ltd) will be used for content analysis and
      descriptive statistical analysis and thematic analysis will be used for the analysis of the
      qualitative data.
    

Detailed description: 
      Early childhood vaccination is the most important public health intervention to protect
      against life-threatening infectious diseases worldwide. However, vaccinations are painful and
      result in distress and anxiety for infants and, in many cases, their parents. If vaccination
      pain is not addressed, this pain can lead to subsequent non-adherence with vaccination
      schedules, fears of needles and avoidance of health care. Clinical practice guidelines and
      high-quality synthesized evidence shows that breastfeeding, sucrose, and upright secure
      holding effectively reduce pain during vaccination in infants. Despite the evidence, these
      strategies are not consistently used in practice highlighting an important gap in translating
      this knowledge into practice. Aims. The overall aim of this study is to investigate the
      feasibility, acceptability, preliminary effectiveness and sustainability of parent-targeted
      interventions for pain management during vaccination of infants. To achieve the goal, a
      two-phase pilot randomized control trial is planned. Study one, currently in the data
      collection phase, aims i) to evaluate the feasibility and acceptability of data collection
      tools, participants' recruitment procedures and implementation process of parent-targeted
      interventions prior to infant vaccination at two, four, or six months. ii) to evaluate the
      preliminary effectiveness of parent-targeted interventions prior to infant vaccination in
      promoting the use of pain management strategies during vaccinations of infants at two, four,
      or six months. iii) to identify the parent's knowledge, use, intention and recommendation to
      use the recommended pain management strategies, and facilitators and barriers influencing the
      implementation of the parent-targeted interventions during vaccinations of infants at two,
      four, or six months. Methods. This study is a prospective multi-faceted two-armed pilot
      randomized control trial (RCT). a pilot randomized control trial. The participants are
      parents of infants, recruited before the infants receive their 2, 4, or 6- month
      vaccinations, who responded to the online invitation and consent to participate in this
      study. Parents living in Canada and prior to the infant receiving one of the three
      vaccinations were invited to participate through an online recruitment process. Parents were
      eligible if they have an infant scheduled to receive their 2, 4, or 6-month routine
      vaccination as per the childhood immunization schedule of the province the parents are living
      in, and they read, speak and understand English sufficiently to understand the videos and
      complete the surveys. A sample of 50 parent/infant dyads in each group of control and
      intervention is estimated to be sufficient to achieve the study's goals. The outcome
      measurements are being done by five brief study questionnaires; Baseline demographic
      questionnaire, Baseline knowledge questionnaire, Knowledge utilization questionnaire,
      Acceptability, and feasibility questionnaire. All recruited parents of infants before their
      2, 4, or 6-month vaccination were invited to take part in a baseline survey, aimed to assess
      current awareness, previous use and future intent to use one of the recommended pain care
      strategies (breastfeeding, sucrose/other sweet solutions and holding). Different methods were
      taken for online recruiting of the participants. Brief information of the study goals and the
      researchers' affiliation followed by a hyperlink to the survey were posted on different
      online platforms. When participants clicked on the survey link, they were directed to a
      REDCap (Research Electronic Data Capture) survey.

      If the respondents are not eligible, a brief message containing a thank-you note and
      explanation about their in-eligibility to continue the study was sent to them. However, if
      they meet the listed screening criteria, they are directed to the next page which is the
      study's consent form. They are invited to read the forms and provide online informed consent
      to participate in this study. They are then being directed to the next page which is the
      demographic questionnaires. A hyperlink directs participants to a brief survey asking
      questions about previous awareness and intention to use specified recommended pain management
      strategies in their infants' future immunization episodes. In addition, they were asked to
      provide an email address to be contacted for the following steps of the study. Eligible
      parents of infants who respond to the study invitation are being randomly allocated to 1 of 2
      groups (Intervention and control) in a 1:1 ratio before the infants' 2, 4, or 6-months
      vaccination. Participants were stratified according to the infant's age of receiving the
      vaccine (two, four, or six months). There are two interventions in the study one being
      compared: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos,
      pamphlet, and MIAS&Q. The Be Sweet to Babies vaccination pain management videos and pamphlet
      are provided to all participants. Those in the intervention arm is also be given MIAS&Q. Be
      Sweet to Babies vaccination pain management videos showing parents how to use breastfeeding,
      upright secure holding, and a small volume of the sweet solution during vaccination, are
      used. In addition, the pamphlet is a knowledge translation tool developed in partnership with
      the Children Hospital of Eastern Ontario (CHEO) and Ottawa Public Health. MIAS&Q includes
      five questions and statements based on MI approach consists of four scaled questions and two
      open-ended questions, aimed to present brief informative and affirmative questions and
      statements. After the intervention, the impact of the vaccination pain management video and
      brochure followed by MIAS&Q questions are being evaluated by a brief online survey exploring
      the use of pain management (breastfeeding or sucrose and upright secure holding) during
      infants' vaccination in both groups. Following that, the opinion of parents about the
      understandability, applicability, feasibility, and acceptability of this study are evaluated.
      All data are being collected electronically using REDCap survey tool. SPSS version 23.0 (SPSS
      Inc, Chicago, Illinois) will be used to perform all descriptive and inferential statistical
      analyses. NVivo version 11.0 (Qualitative data analysis Software; QSR International Pty Ltd)
      will be used for content analysis and descriptive statistical analysis and thematic analysis
      will be used for the analysis of the qualitative data.
    

Intervention name(s): MIAS&Q; Be Sweet to Babies Videos and Pamphlet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): There were two interventions compared in this study: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS&Q. The Be Sweet to Babies vaccination pain management videos and pamphlet were provided to all participants as this information is publicly available, and demonstrates the effectiveness of the evidence-based recommended vaccination pain management strategies for infants. In addition, a pamphlet was used which was developed in partnership with CHEO and Ottawa Public Health as a knowledge translation tool. Those in the intervention arm were also given MIAS&Q included five questions and statements based on the MI approach consisted of four scaled questions and two open-ended questions, aimed to present brief informative and affirmative questions and statements to help the parents reflect on their own thoughts and support them to advocate for the use of the recommended pain management strategies during their infant's vaccination.; The Be Sweet to Babies vaccination pain management videos and pamphlet will be provided to all participants. Be Sweet to Babies vaccination pain management videos showing parents how to use breastfeeding, upright secure holding, and a small volume of sweet solution during vaccination, will be used. This pamphlet is a knowledge translation tool previously developed in partnership with the Children Hospital of Eastern Ontario (CHEO) and Ottawa Public Health and has been publicly available on the Ottawa Public Health Website since June 2013. The content presented about pain management for infants during vaccination is the same information as the video.
Other intervention name(s): MI based affirmation statements and questions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Childhood Vaccination,; Knowledge Translation,; Pain management,; Parents.